If you are a professional in Regulatory Affairs, Clinical Affairs, Quality Assurance, Quality Engineering, Medical Affairs, Drug Safety, Research and Development, Medical Writing, Marketing and Business Development or Licensing you’ve come to the right place.
We all know change is difficult when it comes to your career. Even though most people, on average, change jobs every 39 months, it is the thought of change that actually stalls or paralyzes them. You’ve heard it before, “paralysis by analysis”. Don’t let yourself fall into this trap.Discuss your options confidentially with one of our Life Sciences specialists. They know what you’re going through emotionally and professionally and can work closely with you to find your perfect opportunity.Our team of “industry insiders” know what the key motives for change are and will help you assess your true feelings for exploring change while helping you find what’s of critical importance to you in your next opportunity.We have found the following 6 issues to be behind over 90% of why people leave their current position
Lack of challenge
No career advancement (or slow career advancement)
Compensation is not commensurate with responsibilities
No sense of job security
Location (commute is brutal)
Co worker issues
If your need is immediate, we will confidentially discuss what is currently available in todays market and develop a plan of action for you.If your need is longer term, we will confidentially discuss what you would like to see in your next opportunity, keep their antenna up and contact you when we find it.Either way, if you are in any of our specialty areas, let us know about your career aspirations and how to contact you.Please submit a copy of your resume by clicking here.
Friday, July 25, 2008
Wednesday, April 9, 2008
Resume Writing Tips
Your resume writing should be succinct, clear and easy to read. No resume writing that is overly flowery, with hyperbole and superlatives that exaggerate your qualifications. Your resume writing should include lots of organization - bullets, lists and italics that make important points stand out, and plenty of white space.
Make sure that when you do your resume writing you catch all the grammatical and punctuation errors and all the typographical mistakes as well. There is nothing that will get your resume thrown on the junk pile faster than a grammar mistake or a misspelled word. No matter what experience you list or what qualifications you clarify you probably won't get the interview if your resume writing indicates you are sloppy or a poor communicator.
Your resume writing should be focused and powerful. If you don't want to state an objective (which, by the way, if stated, should be very specific) you should at least clarify a job title or industry somewhere up front. Your name and contact information should be immediately followed by "clinical professional," centered on a line by itself, for example.
While your resume writing should certainly be honest and factual you also want to stand out and put your best job search foot forward with the use of powerful words. Starting each sentence with a powerful word is one good way of making yourself unique. Some powerful words are "accomplished," "launched," "managed," "tackled," and "coordinated." See the powerful action in these? This type of resume writing makes you look proactive, strong, focused and determined.
Writing Your Qualifications
Resume writing is first and foremost about stating your qualifications and experience, of course. Here are some tips on writing this section of your resume.
You should always list the positions you held in reverse chronological order. In other words, list the most recent job first and the job you held first is last on the list when you do your resume writing. Those jobs that you held years ago and probably were more entry level than your later positions don't need much detail.
Where your resume writing should be more detailed is in the explanation of your most recent jobs and the ones whose responsibilities and achievements have the most relevance to the position for which you are now applying. Make sure the information you provide is detailed and quantifiable, not long, confusing or boring.
There is no hard and fast rule, when resume writing, about whether to begin each job with the job title or the name of the firm. Just decide on which will most impress the potential employer, and then start with that - and make it bold. Once decided, however, your resume writing must be consistent.
You should never start one job with the job title and your next position with the name of the firm. If the firm is not well known, it’s wise to parenthetically explain what the company does and is. Your dates of work should come last, and be italicized. There is never any reason, if you were employed more than a year, to include the months. All you need to state are the years of employment.
It is perfectly acceptable, when resume writing - and, in fact, is encouraged - to include volunteer work that is relevant.
If you're writing a resume for a Life Sciences position here are a few resume tips.
1) Technical Skills Come First
The first resume tip is to put your technical skills, training, education and knowledge at the top of your resume. Make sure it is detailed and organized and that your technical expertise is clear. Keep in mind that prior to finding its way to the prospective employer the resume is going to be read by a gatekeeper, and will likely be perused for important keywords. The best resume tip to get your resume in front of the employer is to make sure you include relevant keywords, such as industry or job jargon, an all operating systems and programs with which you are proficient.
2) Quantify Your Past Results
Be factual with your experience, quantifying it where you can. You could, for instance, highlight the regulatory submissions you’ve filed, the types of clinical trials you’ve managed, the products you’ve marketed, or the types of therapeutic areas you’ve researched. What was the quantifiable impact your actions had on the company? Did your actions help move a drug through a phase quicker, launch a drug or device sooner, thus saving money or making additional profits for your company? If so, state it unequivocally on your resume
3) Use Action Words
Be active rather than passive in your resume. Begin each sentence with an action, keeping it in the past tense. For example, which description do you think is better?:
I was a call Quality Engineer
Implemented effective quality systems resulting in ISO 13485 compliance
It is important to clearly describe the value you provided to the employer in the past tense and starting with an action word.
4) Give Yourself Credit
Blow your own horn. This is not the time to be shy. Treat your resume as a marketing and sales tool for yourself. Write it as if you are the product and the employer the consumer. Sell yourself. If you have a significant accomplishment that doesn't seem relevant to the job list it separately, but do list it.
5) Be As Short As Possible While Still Being Totally Clear
Keep your resume as concise as practical, without minimize the point size to make it hard to read, or eliminating needed white space. If your resume includes fewer than six years of experience you should be able to keep it to one page. Unless you are applying for a senior executive position, however, you shouldn't exceed three pages. Some of the ways to be concise is to leave out the details of projects of which you were not the key part. Articles and pronouns can be eliminated - you don't need a, an or the - and you definitely don't need I.
6) Don't Give Any More Information Than The Reader Needs
Eliminate all unimportant, or non-pertinent information, as well as those things that will give away your right to be considered without bias. You should never, for example, include your resume, your marital status, any indication of your health or age, or any associations that would make clear your religious, sexual preference or political affiliation. You don't need to tell a prospective employer, for example, that references are available, nor do you need to name supervisors at this point.
7) No Silly Mistakes
The final resume tip is to check for errors. Check yourself for grammatical and punctuation errors as well as typographical mistakes. Have someone else proofread your resume whose opinion and ability to catch errors you are confident about. This is probably the most important resume tip of all.
Make sure that when you do your resume writing you catch all the grammatical and punctuation errors and all the typographical mistakes as well. There is nothing that will get your resume thrown on the junk pile faster than a grammar mistake or a misspelled word. No matter what experience you list or what qualifications you clarify you probably won't get the interview if your resume writing indicates you are sloppy or a poor communicator.
Your resume writing should be focused and powerful. If you don't want to state an objective (which, by the way, if stated, should be very specific) you should at least clarify a job title or industry somewhere up front. Your name and contact information should be immediately followed by "clinical professional," centered on a line by itself, for example.
While your resume writing should certainly be honest and factual you also want to stand out and put your best job search foot forward with the use of powerful words. Starting each sentence with a powerful word is one good way of making yourself unique. Some powerful words are "accomplished," "launched," "managed," "tackled," and "coordinated." See the powerful action in these? This type of resume writing makes you look proactive, strong, focused and determined.
Writing Your Qualifications
Resume writing is first and foremost about stating your qualifications and experience, of course. Here are some tips on writing this section of your resume.
You should always list the positions you held in reverse chronological order. In other words, list the most recent job first and the job you held first is last on the list when you do your resume writing. Those jobs that you held years ago and probably were more entry level than your later positions don't need much detail.
Where your resume writing should be more detailed is in the explanation of your most recent jobs and the ones whose responsibilities and achievements have the most relevance to the position for which you are now applying. Make sure the information you provide is detailed and quantifiable, not long, confusing or boring.
There is no hard and fast rule, when resume writing, about whether to begin each job with the job title or the name of the firm. Just decide on which will most impress the potential employer, and then start with that - and make it bold. Once decided, however, your resume writing must be consistent.
You should never start one job with the job title and your next position with the name of the firm. If the firm is not well known, it’s wise to parenthetically explain what the company does and is. Your dates of work should come last, and be italicized. There is never any reason, if you were employed more than a year, to include the months. All you need to state are the years of employment.
It is perfectly acceptable, when resume writing - and, in fact, is encouraged - to include volunteer work that is relevant.
If you're writing a resume for a Life Sciences position here are a few resume tips.
1) Technical Skills Come First
The first resume tip is to put your technical skills, training, education and knowledge at the top of your resume. Make sure it is detailed and organized and that your technical expertise is clear. Keep in mind that prior to finding its way to the prospective employer the resume is going to be read by a gatekeeper, and will likely be perused for important keywords. The best resume tip to get your resume in front of the employer is to make sure you include relevant keywords, such as industry or job jargon, an all operating systems and programs with which you are proficient.
2) Quantify Your Past Results
Be factual with your experience, quantifying it where you can. You could, for instance, highlight the regulatory submissions you’ve filed, the types of clinical trials you’ve managed, the products you’ve marketed, or the types of therapeutic areas you’ve researched. What was the quantifiable impact your actions had on the company? Did your actions help move a drug through a phase quicker, launch a drug or device sooner, thus saving money or making additional profits for your company? If so, state it unequivocally on your resume
3) Use Action Words
Be active rather than passive in your resume. Begin each sentence with an action, keeping it in the past tense. For example, which description do you think is better?:
I was a call Quality Engineer
Implemented effective quality systems resulting in ISO 13485 compliance
It is important to clearly describe the value you provided to the employer in the past tense and starting with an action word.
4) Give Yourself Credit
Blow your own horn. This is not the time to be shy. Treat your resume as a marketing and sales tool for yourself. Write it as if you are the product and the employer the consumer. Sell yourself. If you have a significant accomplishment that doesn't seem relevant to the job list it separately, but do list it.
5) Be As Short As Possible While Still Being Totally Clear
Keep your resume as concise as practical, without minimize the point size to make it hard to read, or eliminating needed white space. If your resume includes fewer than six years of experience you should be able to keep it to one page. Unless you are applying for a senior executive position, however, you shouldn't exceed three pages. Some of the ways to be concise is to leave out the details of projects of which you were not the key part. Articles and pronouns can be eliminated - you don't need a, an or the - and you definitely don't need I.
6) Don't Give Any More Information Than The Reader Needs
Eliminate all unimportant, or non-pertinent information, as well as those things that will give away your right to be considered without bias. You should never, for example, include your resume, your marital status, any indication of your health or age, or any associations that would make clear your religious, sexual preference or political affiliation. You don't need to tell a prospective employer, for example, that references are available, nor do you need to name supervisors at this point.
7) No Silly Mistakes
The final resume tip is to check for errors. Check yourself for grammatical and punctuation errors as well as typographical mistakes. Have someone else proofread your resume whose opinion and ability to catch errors you are confident about. This is probably the most important resume tip of all.
Friday, March 21, 2008
RA Manager / Senior Regulatory Affairs Manager
Regulatory Affairs Manager / Senior Regulatory Affairs Manager
Exciting opportunity for to work with an established multinational company in their vaccines division! This is a chance to be part of having a lasting impact on humanity as this division is working on vaccines in some critical areas such as pandemic flu, seasonal flu as well as others.
They are seeking an individual who have a strong scientific and regulatory skills who have some experience with vaccines.
The responsibilities are as follows:
Develop and execute regulatory plans for complex US Vaccine projects including new product development and maintenance of licenses/authorizations for existing marketing authorizations
Provide regulatory input on nonclinical, clinical and CMC development issues
Represent or lead the RA function on assigned cross-functional project teams
Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
Establish appropriate communication within RA and other functions primarily at project level
Perform gap analysis and propose solutions
Develop and document sound regulatory decisions and justifications
Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
May provide direct supervision of individuals
May review promotional material or SOP’s for compliance with local and global regulations
The idea candidate will have the following qualifications:
Strong basis of Regulatory knowledge, previous experience in vaccine development will be an advantage
Strong Scientific Knowledge
Direct Experience with FDA and other Health Authorities
Experience with BLA/NDA and supplement submissions
Ability to manage complex projects and timelines in a matrix team environment
Experience working on global project teams
Strong verbal and written communication and presentation skills
Demonstrated interpersonal skills including strong negotiation skills
Ability to independently identify compliance risks and escalate when necessary
Ability to lead and coach others
Master's degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA, including managing people or projects.
Higher degree/PhD will be an advantage
All are encouraged to apply. For additional regulatory affairs openings please visit our website www.executivesg.com
Exciting opportunity for to work with an established multinational company in their vaccines division! This is a chance to be part of having a lasting impact on humanity as this division is working on vaccines in some critical areas such as pandemic flu, seasonal flu as well as others.
They are seeking an individual who have a strong scientific and regulatory skills who have some experience with vaccines.
The responsibilities are as follows:
Develop and execute regulatory plans for complex US Vaccine projects including new product development and maintenance of licenses/authorizations for existing marketing authorizations
Provide regulatory input on nonclinical, clinical and CMC development issues
Represent or lead the RA function on assigned cross-functional project teams
Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
Establish appropriate communication within RA and other functions primarily at project level
Perform gap analysis and propose solutions
Develop and document sound regulatory decisions and justifications
Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
May provide direct supervision of individuals
May review promotional material or SOP’s for compliance with local and global regulations
The idea candidate will have the following qualifications:
Strong basis of Regulatory knowledge, previous experience in vaccine development will be an advantage
Strong Scientific Knowledge
Direct Experience with FDA and other Health Authorities
Experience with BLA/NDA and supplement submissions
Ability to manage complex projects and timelines in a matrix team environment
Experience working on global project teams
Strong verbal and written communication and presentation skills
Demonstrated interpersonal skills including strong negotiation skills
Ability to independently identify compliance risks and escalate when necessary
Ability to lead and coach others
Master's degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA, including managing people or projects.
Higher degree/PhD will be an advantage
All are encouraged to apply. For additional regulatory affairs openings please visit our website www.executivesg.com
Friday, March 14, 2008
Current Openings
Several Director Regulatory Affairs Positions - in both Pharmaceuticals and Medical Device
in the following locations: Chicago, Boston, LA , North Carolina
VP Chemistry Manufacturing and Control
Start up company - Philadelphia
VP Regulatory CMC
RTP, North Carolina
VP Regulatory Affairs - Biotechnology
Los Angeles, CA
Director of Clinical and Scientific Research
Hyderabad, India
in the following locations: Chicago, Boston, LA , North Carolina
VP Chemistry Manufacturing and Control
Start up company - Philadelphia
VP Regulatory CMC
RTP, North Carolina
VP Regulatory Affairs - Biotechnology
Los Angeles, CA
Director of Clinical and Scientific Research
Hyderabad, India
Regulatory Affairs Managers & Associate Directors
Rapidly growing leader in the Medical Device Industry is looking to add talented professionals to their regulatory affairs team.
This is an exciting opporunity with temendous professional growth potential. If you are looking to advance your career in regulatory affairs and have experiance with class II medical devices, particularly if you work with any software driven / electromechanical products you will find this position very exciting.
Some of the responsibitities include:
Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations;
Ensure that regulatory submissions for class II products, strong 510K submissions understanding
Monitor applicable regulatory requirements; assure compliance with company and external standards;
Identify risk areas and develop alternative courses of action including anticipation of Regulators responses through scenario planning and development of contingency plans;
Establish a leadership position on project development teams and ensure appropriate communication within RA and across other functional areas;
Develop and document sound regulatory decisions and justifications
Review of labels, labeling and promotional material for compliance with local and global regulations.
Lead and/or participate in RA and Corporate operational efficiency initiatives.
Requirements
Job Requirements
Bachelor’s degree in engineering or scientific discipline, with a minimum of 3 years direct experience in US regulatory submissions for hardware/software medical device regulatory submissions.
Higher degree/PhD will be an advantage.
International regulatory experience/exposure preferable.
Experience in hardware/software medical device development, regulations, standards, and current industry practices.
This company is offering a highly compedative salary and benifits package. For more information about these great Regulatory Affairs Jobs please call Katie Corliss @ 207-510-6666 or visit our website at www.executivesg.com to submitt your resume for consideration.
This is an exciting opporunity with temendous professional growth potential. If you are looking to advance your career in regulatory affairs and have experiance with class II medical devices, particularly if you work with any software driven / electromechanical products you will find this position very exciting.
Some of the responsibitities include:
Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations;
Ensure that regulatory submissions for class II products, strong 510K submissions understanding
Monitor applicable regulatory requirements; assure compliance with company and external standards;
Identify risk areas and develop alternative courses of action including anticipation of Regulators responses through scenario planning and development of contingency plans;
Establish a leadership position on project development teams and ensure appropriate communication within RA and across other functional areas;
Develop and document sound regulatory decisions and justifications
Review of labels, labeling and promotional material for compliance with local and global regulations.
Lead and/or participate in RA and Corporate operational efficiency initiatives.
Requirements
Job Requirements
Bachelor’s degree in engineering or scientific discipline, with a minimum of 3 years direct experience in US regulatory submissions for hardware/software medical device regulatory submissions.
Higher degree/PhD will be an advantage.
International regulatory experience/exposure preferable.
Experience in hardware/software medical device development, regulations, standards, and current industry practices.
This company is offering a highly compedative salary and benifits package. For more information about these great Regulatory Affairs Jobs please call Katie Corliss @ 207-510-6666 or visit our website at www.executivesg.com to submitt your resume for consideration.
Thursday, February 7, 2008
Current Openings
The positions that we are working are always changing. This is not a complete list but I think a good overview.
As you know I specialize in Regulatory & Drug Safety, however my recruiters all have different specialities and we can help in almost every area.
We work both nationally as well as internationally.
RA Manager - International
NJ
AD Regulatory - Consumer Products - OTC
NJ
Sr. Supplier Quality Engineer
MA
Chief MSL
Charlotte
NC
AD Regulatory and Project Mgt
Philadelphia
PA
VP of CMC
Philadelphia
Sr. RA Liscensing Specialist
Waltham
MA
Sr. RA Specialist
Waltham
MA
Sr. RA Specialist
Waltham
MA
RA Specialist
Waltham
MA
RA Specialist
Waltham
MA
Dir. Reg Affairs - Pharma
Chicago
IL
RA Publisher
Chicago North
RA Liscensing Specialist
Waltham
MA
Medical Science Liaison
San Fransisco
CA
RA Manager
Openings in MA, NJ, IL and PA
Director Drug Safety
NJ
RA Project Manager
NJ
Dir Reg Affairs -Medical Device
IL
RA Specialist -Pharmacueticals
Openings in Submissions, Liscening and Operations
MA, IL, NJ
As you know I specialize in Regulatory & Drug Safety, however my recruiters all have different specialities and we can help in almost every area.
We work both nationally as well as internationally.
RA Manager - International
NJ
AD Regulatory - Consumer Products - OTC
NJ
Sr. Supplier Quality Engineer
MA
Chief MSL
Charlotte
NC
AD Regulatory and Project Mgt
Philadelphia
PA
VP of CMC
Philadelphia
Sr. RA Liscensing Specialist
Waltham
MA
Sr. RA Specialist
Waltham
MA
Sr. RA Specialist
Waltham
MA
RA Specialist
Waltham
MA
RA Specialist
Waltham
MA
Dir. Reg Affairs - Pharma
Chicago
IL
RA Publisher
Chicago North
RA Liscensing Specialist
Waltham
MA
Medical Science Liaison
San Fransisco
CA
RA Manager
Openings in MA, NJ, IL and PA
Director Drug Safety
NJ
RA Project Manager
NJ
Dir Reg Affairs -Medical Device
IL
RA Specialist -Pharmacueticals
Openings in Submissions, Liscening and Operations
MA, IL, NJ
Wednesday, October 3, 2007
This is a great artical on Personalized Medicine
Advancing Personalized Medicine- FDA’s Perspective and Role
Credit: FDA Consumer Health Information
e-published on MedicineandBiotech.com October 1st, 2007
Each person has a unique set of chemical blueprints that determine how his or her body looks and functions. These blueprints are contained in their own DNA which is made up of two twisting sequences or single strands that are able to be paired with another.
Here we discuss the following important topics of interest:
* What is Personalized Medicine?
* How Does Personalized Medicine Work?
* What's Involved?
* What are the Benefits of Personalized Medicine?
* What are the Challenges?
* FDA's Role
Medications have been prescribed over the years mostly by trial-and-error to reach the best dose for each patient. Typically, doctors diagnosed a condition and then selected what they believed was the most promising drug for treatment. If one didn't work, they'd try another.
Today, as science gives way to the understanding that people and diseases differ at the genetic or molecular level, doctors are learning to tailor treatments—or personalize them—to individuals more effectively.
By using "genomics," or the identification of genes and how they relate to drug treatment, doctors will be able to treat patients based on the actual biology of a disease and not just according to symptoms, and as an individual, not just a member of a population.
The Food and Drug Administration is especially interested in clearing the pathway for the development of safe and effective, leading-edge products that this burgeoning field of genomics is spawning—multiple tools, technologies, and sciences that will translate into the discovery and safety of drugs and medical products that the agency regulates.
By ensuring that new products and technologies are developed and made available to doctors and patients as effectively as possible, FDA believes this can only enhance the health of all Americans.
What is Personalized Medicine?
Personalized medicine uses information about a person's genetic makeup to tailor products that will detect, treat, or prevent disease in that person. The goal is to get the best medical outcomes by choosing treatments that work well with a person's genetic profile, or with certain characteristics in the person's blood or cells.
Scientifically, personalized medicine is known as pharmacogenomics (drugs combined with genes), or how genetic differences in individuals affect the way people respond to drugs. The science of pharmacogenomics tries to answer questions like: Why do some people get cancer and others don't? Why is cancer more aggressive in this person and not in that one? Why does this drug work for him and not for her? Why do some people show toxicity to a drug while others don't? Why does someone need twice the standard dose to be effective? And why do others need only half of the standard dose?
How Does Personalized Medicine Work?
Someone diagnosed with colon cancer today would receive a treatment based on standard medication and dosing guidelines for that disease. The doctor might factor in weight, age, medical history, and how any blood relatives might have reacted to a certain medication. But the doctor cannot know how that person will respond to the medication, which may help the cancer or have no affect at all. The person could experience terrible side effects or none at all. And, it may be necessary for several revisits to the doctor for adjusting the dosage or to switch medications. This is considered the trial-and-error approach to medicine.
With personalized medicine, people may be able to take a genetic test that can help determine which diseases they are likely to develop, and a blood test to help determine which genetic variations they may have—even before they've taken a single dose of medicine. Based on test results, the doctor could tailor a patient's treatment by avoiding using a certain drug, prescribing another, or altering a dose to match the body's genetics. A person's unique genetic profile can help a doctor personalize treatments.
What's Involved?
New technologies and tools have been developed as a direct result of the nation's effort to understand DNA—deoxyribonucleic acid—the blueprint that determines how each person’s body looks and functions. Those technologies and what they intend to accomplish within personalized medicine include:
Functional genomics—measures gene expression under normal and troubled conditions and attempts to predict the gene expression profiles for these conditions.
Structural genomics—addresses questions concerning individual genetic differences and the impact that these genetic differences have on the development of disease.
Proteomics—seeks to discover all proteins in a living organism, and determine their function and how they affect each other.
Metabolomics—studies all the molecules involved in metabolism (metabolites) in a living organism by evaluating tissues and body fluids, such as urine, blood, plasma, and saliva for changes.
Genomics and Medical Devices—understands how certain diseases, or increased risks pass from generation to generation.
Nanotechnology—uses materials or devices at the level of molecules and atoms too small to be seen with a conventional laboratory microscope.
What are the Benefits of Personalized Medicine?
* Diagnosing disease or predicting risk of disease.
* Determining whether a treatment is working or not.
* Monitoring healthy people to detect early signs of disease.
* Producing safer drugs by predicting the potential for adverse effects earlier.
* Targeting specific groups of people most likely to benefit from a drug, while keeping its use from those who may be harmed by it.
* Providing researchers the opportunity to get a global view of the events that are always changing within a cell.
* Producing new classes of structural materials that are expected to bring about lighter, stronger, smarter, cheaper, cleaner, and more precise medical products.
What are the Challenges of Personalized Medicine?
Personalized medicine is new and still in the early stages. Using a pharmacogenomic test to determine who will respond to a treatment or who should not get a treatment may narrow the market for certain drugs—manufacturers may be reluctant to invest time and money. Identifying all of the genetic variations (perhaps millions) that may exist could take years. How a person responds to a medication may not be determined by just one gene, but rather, several genes and their products interacting with each other.
This new way of doing things likely will be expensive and time-consuming.
FDA's Role
Tests that scientists are beginning to use on body fluids and cells to determine the variations of disease were not available in the past. Such tests, coupled with the understanding of the expression of each individual’s genes, will allow scientists to detect differences between patients and diseases much more precisely. FDA's Critical Path Initiative—the scientific process through which a medical product is transformed from discovery to development—is organizing work across 76 science and regulatory areas to improve medical product development, especially for gene-oriented drugs and diagnostic tests.
FDA encourages applications for approval of new tools and technologies for a number of reasons:
* The ability to bridge data gaps that exist in preclinical studies (animals) and clinical studies (humans) used to assess the safety and effectiveness of products it regulates.
* Technologies can be used not only in the discovery phase of potential products, but also in the safety and effectiveness evaluation phase of development and submission to the agency.
* Adverse events likely can be predicted prior to the approval and marketing of a product.
FDA's role in personalized medicine will be to bring balance to an evolving science in a way that does not inhibit its growth. Thousands of cancer patients are already benefiting from several targeted drugs, such as Tarceva and Gleevec, both known to work better in people with certain genetic profiles. Hope for the future is that personalized medicine will improve the safety, quality and effectiveness of health care for every American.
Credit: FDA Consumer Health Information
e-published on MedicineandBiotech.com October 1st, 2007
Each person has a unique set of chemical blueprints that determine how his or her body looks and functions. These blueprints are contained in their own DNA which is made up of two twisting sequences or single strands that are able to be paired with another.
Here we discuss the following important topics of interest:
* What is Personalized Medicine?
* How Does Personalized Medicine Work?
* What's Involved?
* What are the Benefits of Personalized Medicine?
* What are the Challenges?
* FDA's Role
Medications have been prescribed over the years mostly by trial-and-error to reach the best dose for each patient. Typically, doctors diagnosed a condition and then selected what they believed was the most promising drug for treatment. If one didn't work, they'd try another.
Today, as science gives way to the understanding that people and diseases differ at the genetic or molecular level, doctors are learning to tailor treatments—or personalize them—to individuals more effectively.
By using "genomics," or the identification of genes and how they relate to drug treatment, doctors will be able to treat patients based on the actual biology of a disease and not just according to symptoms, and as an individual, not just a member of a population.
The Food and Drug Administration is especially interested in clearing the pathway for the development of safe and effective, leading-edge products that this burgeoning field of genomics is spawning—multiple tools, technologies, and sciences that will translate into the discovery and safety of drugs and medical products that the agency regulates.
By ensuring that new products and technologies are developed and made available to doctors and patients as effectively as possible, FDA believes this can only enhance the health of all Americans.
What is Personalized Medicine?
Personalized medicine uses information about a person's genetic makeup to tailor products that will detect, treat, or prevent disease in that person. The goal is to get the best medical outcomes by choosing treatments that work well with a person's genetic profile, or with certain characteristics in the person's blood or cells.
Scientifically, personalized medicine is known as pharmacogenomics (drugs combined with genes), or how genetic differences in individuals affect the way people respond to drugs. The science of pharmacogenomics tries to answer questions like: Why do some people get cancer and others don't? Why is cancer more aggressive in this person and not in that one? Why does this drug work for him and not for her? Why do some people show toxicity to a drug while others don't? Why does someone need twice the standard dose to be effective? And why do others need only half of the standard dose?
How Does Personalized Medicine Work?
Someone diagnosed with colon cancer today would receive a treatment based on standard medication and dosing guidelines for that disease. The doctor might factor in weight, age, medical history, and how any blood relatives might have reacted to a certain medication. But the doctor cannot know how that person will respond to the medication, which may help the cancer or have no affect at all. The person could experience terrible side effects or none at all. And, it may be necessary for several revisits to the doctor for adjusting the dosage or to switch medications. This is considered the trial-and-error approach to medicine.
With personalized medicine, people may be able to take a genetic test that can help determine which diseases they are likely to develop, and a blood test to help determine which genetic variations they may have—even before they've taken a single dose of medicine. Based on test results, the doctor could tailor a patient's treatment by avoiding using a certain drug, prescribing another, or altering a dose to match the body's genetics. A person's unique genetic profile can help a doctor personalize treatments.
What's Involved?
New technologies and tools have been developed as a direct result of the nation's effort to understand DNA—deoxyribonucleic acid—the blueprint that determines how each person’s body looks and functions. Those technologies and what they intend to accomplish within personalized medicine include:
Functional genomics—measures gene expression under normal and troubled conditions and attempts to predict the gene expression profiles for these conditions.
Structural genomics—addresses questions concerning individual genetic differences and the impact that these genetic differences have on the development of disease.
Proteomics—seeks to discover all proteins in a living organism, and determine their function and how they affect each other.
Metabolomics—studies all the molecules involved in metabolism (metabolites) in a living organism by evaluating tissues and body fluids, such as urine, blood, plasma, and saliva for changes.
Genomics and Medical Devices—understands how certain diseases, or increased risks pass from generation to generation.
Nanotechnology—uses materials or devices at the level of molecules and atoms too small to be seen with a conventional laboratory microscope.
What are the Benefits of Personalized Medicine?
* Diagnosing disease or predicting risk of disease.
* Determining whether a treatment is working or not.
* Monitoring healthy people to detect early signs of disease.
* Producing safer drugs by predicting the potential for adverse effects earlier.
* Targeting specific groups of people most likely to benefit from a drug, while keeping its use from those who may be harmed by it.
* Providing researchers the opportunity to get a global view of the events that are always changing within a cell.
* Producing new classes of structural materials that are expected to bring about lighter, stronger, smarter, cheaper, cleaner, and more precise medical products.
What are the Challenges of Personalized Medicine?
Personalized medicine is new and still in the early stages. Using a pharmacogenomic test to determine who will respond to a treatment or who should not get a treatment may narrow the market for certain drugs—manufacturers may be reluctant to invest time and money. Identifying all of the genetic variations (perhaps millions) that may exist could take years. How a person responds to a medication may not be determined by just one gene, but rather, several genes and their products interacting with each other.
This new way of doing things likely will be expensive and time-consuming.
FDA's Role
Tests that scientists are beginning to use on body fluids and cells to determine the variations of disease were not available in the past. Such tests, coupled with the understanding of the expression of each individual’s genes, will allow scientists to detect differences between patients and diseases much more precisely. FDA's Critical Path Initiative—the scientific process through which a medical product is transformed from discovery to development—is organizing work across 76 science and regulatory areas to improve medical product development, especially for gene-oriented drugs and diagnostic tests.
FDA encourages applications for approval of new tools and technologies for a number of reasons:
* The ability to bridge data gaps that exist in preclinical studies (animals) and clinical studies (humans) used to assess the safety and effectiveness of products it regulates.
* Technologies can be used not only in the discovery phase of potential products, but also in the safety and effectiveness evaluation phase of development and submission to the agency.
* Adverse events likely can be predicted prior to the approval and marketing of a product.
FDA's role in personalized medicine will be to bring balance to an evolving science in a way that does not inhibit its growth. Thousands of cancer patients are already benefiting from several targeted drugs, such as Tarceva and Gleevec, both known to work better in people with certain genetic profiles. Hope for the future is that personalized medicine will improve the safety, quality and effectiveness of health care for every American.
RAPS Conference 2007
It was great to see so many of you at RAPS 2007!!!!
Those of you who I didn't get a chance to meet hopeful we can connect another time. What an exciting time to be in regulatory. I am always just thrilled to hear about all of the new products and so many companies are working on.
Have a great day!
Katie
Those of you who I didn't get a chance to meet hopeful we can connect another time. What an exciting time to be in regulatory. I am always just thrilled to hear about all of the new products and so many companies are working on.
Have a great day!
Katie
Tuesday, September 18, 2007
RAPS 2007 Annual Conference
I am going to be attending the RAPS 2007 Annual Conference in Boston on Monday September 24th.
My hope is to continue learning about this exciting field and how I as a recruiter can best serve all of you in filling positions or searching for a new job.
I am looking to network with as many regulatory professionals as possible and an open to your suggestion about what trainings it maybe helpful for me to attend and who else I should meet while I am there.
If you are planning to attend please let me know I would love to meet up and say hello!
Katie Corliss
207-510-6666 ext 122
kcorliss@executivesg.com
My hope is to continue learning about this exciting field and how I as a recruiter can best serve all of you in filling positions or searching for a new job.
I am looking to network with as many regulatory professionals as possible and an open to your suggestion about what trainings it maybe helpful for me to attend and who else I should meet while I am there.
If you are planning to attend please let me know I would love to meet up and say hello!
Katie Corliss
207-510-6666 ext 122
kcorliss@executivesg.com
3rd Quarter Update
I just wanted to drop you a quick note to let all of you know that with the 3rd quarter quickly coming to an end there are a lot of companies looking at ramping up their regulatory groups.
I am working on some great new openings and would love the chance to share them with you. If you haven't been currently looking for a new position this maybe a great time to just listen to what is out there and see if something peeks your interest.
Please let me know the best way for us to catch up by phone.
Have a great day!
Katie Corliss
Senior Vice President, Life Science Practice
Executive Search Group
207-510-6666 ext 122
kcorliss@executivesg.com
I am working on some great new openings and would love the chance to share them with you. If you haven't been currently looking for a new position this maybe a great time to just listen to what is out there and see if something peeks your interest.
Please let me know the best way for us to catch up by phone.
Have a great day!
Katie Corliss
Senior Vice President, Life Science Practice
Executive Search Group
207-510-6666 ext 122
kcorliss@executivesg.com
Thursday, August 2, 2007
Awesome Quality Trainer / Audit Position
My client is a 60 year old company. They were one of the first to bring dialysis treatment out of the hospitals and into the free standing clinics that we see today. They have over 1500 clinics nationwide.
Over the past 20 years they have branch out into the medical device and pharmaceutical area and have marketed products used for dialysis treatment. They now have 4 manufactures plants of there own; 2 in the US 1 in Mexico and 1 in Canada. This is a great opportunity to work with both pharmaceutical and medical device products.
The exciting part of working for this company is that have tremendous resources available to them, they have recently purchased and NDA and they have a plan for continued growth.
They are looking for a Quality Systems Auditor/Trainer to be based in at their North American Headquarter in Waltham MA. There would be about 40% travel involved and it would be a mix of auditing as well as doing training on quality systems as various locations.
If you have a the following background, we should talk! 207-510-6666 ext 122
BS/BA in Engineering, Life Sciences, Quality Management, or significant work experience providing a knowledge base is required.
3-5 years quality system auditing experience in a medical manufacturing environment.
5-7 years working in quality assurance in a medical products manufacturing environment.
Working knowledge of the requirements of 21 CFR 820, 21 CFR 211, and ISO 13485:2003 (knowledge of Canadian and Mexican regulations desired).
Able to travel 40% international and domestic
Over the past 20 years they have branch out into the medical device and pharmaceutical area and have marketed products used for dialysis treatment. They now have 4 manufactures plants of there own; 2 in the US 1 in Mexico and 1 in Canada. This is a great opportunity to work with both pharmaceutical and medical device products.
The exciting part of working for this company is that have tremendous resources available to them, they have recently purchased and NDA and they have a plan for continued growth.
They are looking for a Quality Systems Auditor/Trainer to be based in at their North American Headquarter in Waltham MA. There would be about 40% travel involved and it would be a mix of auditing as well as doing training on quality systems as various locations.
If you have a the following background, we should talk! 207-510-6666 ext 122
BS/BA in Engineering, Life Sciences, Quality Management, or significant work experience providing a knowledge base is required.
3-5 years quality system auditing experience in a medical manufacturing environment.
5-7 years working in quality assurance in a medical products manufacturing environment.
Working knowledge of the requirements of 21 CFR 820, 21 CFR 211, and ISO 13485:2003 (knowledge of Canadian and Mexican regulations desired).
Able to travel 40% international and domestic
Wednesday, May 16, 2007
Current openings!
Dir Reg Affairs -Bio Surgery Division
ChicagoIL
130-170K
Dir Reg Affairs - Pharma - nj
New Providence NJ
160-185K
Dir. Reg Affairs - Pharma-renal
ChicagoIL
160-185K
Sr. Dir. Reg Affairs - Pharma- Clintec
ChicagoIL
175-225K
Sr. Mrg RA, Cell Therapy
Chicago IL
110-125K
Sr. Mrg RA - International
New ProvidenceNJ
90-120K
Sr. Director RA
Hopkinton MA
185-225K
Sr. Manager RA
HopkintonMA
95-125K
RA Specialist
NewtonMA
60-80K
RA Specialist
Beverly MA
60-80K
RA Specialist
Bedford MA
70-80K
RA Specialist
Waltham MA
80-90K
RA Specialist
Rockland MA
85-95K
RA Specialist
Mansfield MA
85-95K
RA Specialist
Danvers/TauntonMA
70-80K
RA Specialist
Rayham MA
85-95K
RA Manager
Canton MA
90-110K
RA Specialist
Bedford MA
70-80K
This is not a complete list things are changing everyday. So please call anytime if you want to learn about what we are working on that maybe a good fit with your background!
Katie Corliss
Executive Search Group
207-510-6666 ext 122
ChicagoIL
130-170K
Dir Reg Affairs - Pharma - nj
New Providence NJ
160-185K
Dir. Reg Affairs - Pharma-renal
ChicagoIL
160-185K
Sr. Dir. Reg Affairs - Pharma- Clintec
ChicagoIL
175-225K
Sr. Mrg RA, Cell Therapy
Chicago IL
110-125K
Sr. Mrg RA - International
New ProvidenceNJ
90-120K
Sr. Director RA
Hopkinton MA
185-225K
Sr. Manager RA
HopkintonMA
95-125K
RA Specialist
NewtonMA
60-80K
RA Specialist
Beverly MA
60-80K
RA Specialist
Bedford MA
70-80K
RA Specialist
Waltham MA
80-90K
RA Specialist
Rockland MA
85-95K
RA Specialist
Mansfield MA
85-95K
RA Specialist
Danvers/TauntonMA
70-80K
RA Specialist
Rayham MA
85-95K
RA Manager
Canton MA
90-110K
RA Specialist
Bedford MA
70-80K
This is not a complete list things are changing everyday. So please call anytime if you want to learn about what we are working on that maybe a good fit with your background!
Katie Corliss
Executive Search Group
207-510-6666 ext 122
Bio2007 was great!
I just wanted to say how good it was to see some many of you last week at Bio2007 in Boston. It was a tremendous show!
It really was a great way to see what a truely exciting time it is to be working in this industry.
It really was a great way to see what a truely exciting time it is to be working in this industry.
Tuesday, April 3, 2007
FDA Approves Combination Drug Janumet For Type 2 Diabetes
Article Date: 03 Apr 2007 - 0:00
PDT email this article printer friendly view or write opinions
Article Also Appears In
Pharma Industry
US Food and Drug Administration has approved a new combination drug called Janumet that combines a new drug and an older drug in a more convenient form for people with type 2 diabetes.Janumet is made by Merck & Co and according to the company it is the first and only tablet that combines a dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin (also known as Januvia), and metformin for treating patients with type 2 diabetes.Januvia, also made by Merck, enhances the body's own ability to lower elevated blood sugar. It was approved by the FDA last October and received a European Commission licence yesterday. It is mostly taken in combination with other drugs.Metformin is an oral drug in the biguanide class. It is the most widely used drug in the treatment of diabetes in the US and was first made by Bristol-Myers Squibb over ten years ago as Glucophage but has since become available in generic form.Pharma analysts are predicting that Janumet will overtake combination treatments based on Januvia because of its convenient single tablet form.According to Merck's statement, the FDA approved Janumet based "upon clinical data including sitagliptin plus metformin as separate tablets."They say that a clinical bioequivalence study has demonstrated that the single tablet Janumet is equivalent to taking sitagliptin plus metformin as separate tablets.The FDA has approved Janumet as an adjunct to diet and exercise to "improve blood sugar (glucose) control in patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone, or in patients already being treated with the combination of sitagliptin and metformin".Merck says that Janumet should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.The FDA announced the decision to the press late last Friday.According to the American Diabetes Association more than 6 million Americans have diabetes and don't know it. Another 54 million are pre-diabetic, with an increased risk of having the disease.The ADA give the main risk factors for type 2 diabetes as:-- being overweight-- having a sendentary lifestyle-- being over 45 years old-- having a family history of diabetesAfrican Americans, Latinos, Native Americans, Asian Americans and Pacific Islanders carry an increased risk, as do women who give birth to babies weighing more than nine pounds (4.1 kilos).
Click here to take the ADA diabetes risk test.
Click here for FDA
Written by: Catharine Paddock
Writer: Medical News Today
Article Date: 03 Apr 2007 - 0:00
PDT email this article printer friendly view or write opinions
Article Also Appears In
Pharma Industry
US Food and Drug Administration has approved a new combination drug called Janumet that combines a new drug and an older drug in a more convenient form for people with type 2 diabetes.Janumet is made by Merck & Co and according to the company it is the first and only tablet that combines a dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin (also known as Januvia), and metformin for treating patients with type 2 diabetes.Januvia, also made by Merck, enhances the body's own ability to lower elevated blood sugar. It was approved by the FDA last October and received a European Commission licence yesterday. It is mostly taken in combination with other drugs.Metformin is an oral drug in the biguanide class. It is the most widely used drug in the treatment of diabetes in the US and was first made by Bristol-Myers Squibb over ten years ago as Glucophage but has since become available in generic form.Pharma analysts are predicting that Janumet will overtake combination treatments based on Januvia because of its convenient single tablet form.According to Merck's statement, the FDA approved Janumet based "upon clinical data including sitagliptin plus metformin as separate tablets."They say that a clinical bioequivalence study has demonstrated that the single tablet Janumet is equivalent to taking sitagliptin plus metformin as separate tablets.The FDA has approved Janumet as an adjunct to diet and exercise to "improve blood sugar (glucose) control in patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone, or in patients already being treated with the combination of sitagliptin and metformin".Merck says that Janumet should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.The FDA announced the decision to the press late last Friday.According to the American Diabetes Association more than 6 million Americans have diabetes and don't know it. Another 54 million are pre-diabetic, with an increased risk of having the disease.The ADA give the main risk factors for type 2 diabetes as:-- being overweight-- having a sendentary lifestyle-- being over 45 years old-- having a family history of diabetesAfrican Americans, Latinos, Native Americans, Asian Americans and Pacific Islanders carry an increased risk, as do women who give birth to babies weighing more than nine pounds (4.1 kilos).
Click here to take the ADA diabetes risk test.
Click here for FDA
Written by: Catharine Paddock
Writer: Medical News Today
List of Openings
Here is a list of some of the positions that we are working on right now!
Vice President Regulatory Affairs - Medical Device
Boston MA
Director Regulatory Affairs – Medical Device
Chicago
Director Regulatory Affairs – Pharmaceuticals
New Jersey
Director Regulatory Affairs – Pharmaceuticals
Chicago
Senior Director Regulatory Affairs – Pharmaceuticals
Chicago
Senior Manager Regulatory Affairs, Cell Therapy
Chicago
Senior Manager Regulatory Affairs - International
New Jersey
Senior Director Regulatory Affairs – Biologic
Hopkinton MA
Senior Manager Regulatory Affairs – Biologic
Hopkinton MA
Sr. Regulatory Affairs Specialist
Several Locations in Massachusetts:
Canton, Beverly, Bedford, Taunton, Davners, Waltham, Hopkinton, Mansfield
~Things are always changing so by the time this is posted something else maybe open or something maybe filled but is you are looking to make a change ~ give us a call and I will be happy to keep you informed as things come up that could be a good next step for you! I have a team of recruiters working for me now and we have a strong presence in the Research Triangle Park Areas as well as the West Coast!
HAVE A GREAT DAY!!
Katie Corliss
207-510-6666
Vice President Regulatory Affairs - Medical Device
Boston MA
Director Regulatory Affairs – Medical Device
Chicago
Director Regulatory Affairs – Pharmaceuticals
New Jersey
Director Regulatory Affairs – Pharmaceuticals
Chicago
Senior Director Regulatory Affairs – Pharmaceuticals
Chicago
Senior Manager Regulatory Affairs, Cell Therapy
Chicago
Senior Manager Regulatory Affairs - International
New Jersey
Senior Director Regulatory Affairs – Biologic
Hopkinton MA
Senior Manager Regulatory Affairs – Biologic
Hopkinton MA
Sr. Regulatory Affairs Specialist
Several Locations in Massachusetts:
Canton, Beverly, Bedford, Taunton, Davners, Waltham, Hopkinton, Mansfield
~Things are always changing so by the time this is posted something else maybe open or something maybe filled but is you are looking to make a change ~ give us a call and I will be happy to keep you informed as things come up that could be a good next step for you! I have a team of recruiters working for me now and we have a strong presence in the Research Triangle Park Areas as well as the West Coast!
HAVE A GREAT DAY!!
Katie Corliss
207-510-6666
Medical Devices
Well if you are a Regulatory Affairs Professional in Massachusetts with Medical Device experience this is your year!
I am working on dozens - yes dozens of jobs, with some great Bay State companies. From the big Fortune 500 device companies that we are all familiar with to some great European companies that are establishing North American Headquarters in MA. This is true the most exciting time I have seen in the medical device field in the past several years. The companies that I am working with are financially stable, growing, investing in their people, and are aggressively pursuing top people.
If you want to learn more feel free to give me a call anytime.
Katie Corliss
Vice President, Life Sciences Practice
207-510-6666 ext 122
I am working on dozens - yes dozens of jobs, with some great Bay State companies. From the big Fortune 500 device companies that we are all familiar with to some great European companies that are establishing North American Headquarters in MA. This is true the most exciting time I have seen in the medical device field in the past several years. The companies that I am working with are financially stable, growing, investing in their people, and are aggressively pursuing top people.
If you want to learn more feel free to give me a call anytime.
Katie Corliss
Vice President, Life Sciences Practice
207-510-6666 ext 122
Senior Director of Regulatory Affairs - IL
Position Title:
Senior Director Regulatory Affairs
Location:
Deerfield, IL
Description:
The Director, Global Regulatory Affairs, is responsible for strategic direction of the RA function supporting the Global Business of the Medication Delivery Division for a company with an 80% market share in this space.This is a very key roll with responsibilities for strategic direction and performance of the RA function within multiple portfolios, regions, or business units including development, implementation and management of plans and standards. Accountable for relationship and communication with Regulatory Authorities. Accountable for regulatory strategy and vision across multiple businesses or divisions The position will direct and manage a team of regulatory professionals responsible for development of global regulatory strategic plans for new product development, as well as life cycle management of existing products. Responsibilities include management of all US submissions (INDs, NDAs, SNDAs), in addition to oversight and support for all international registrations. The Director will be accountable for relationship and communication with FDA, as well as business management and international affiliates
.1) Guide, direct, and lead a team of regulatory professionals in development of strategic plans and regulatory submissions
2) Foster and maintain relationships with regulatory authorities to facilitate interactions on behalf of Baxter
3) Ensure alignment of regulatory strategy to business strategy across all functional areas
4) Oversee development and negotiation of overall plans regarding safety, efficacy, and quality to assure viability for global or regional registrations
5) Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements
6) Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
7) Act as business liaison to the Business Unit, representing Global Regulatory Affairs on the business management team
8) Develop and manage budget as appropriate
9) Act as primary contact with the regulatory authorities including the planning and leadership of meetings
Job Requirements
QUALIFICATIONS
1. Sound basis of scientific knowledge
2. Expert knowledge of pharmaceutical regulations, standards, current industry practices, and strong experience with interpretation and application.
3. Excellent written and verbal communication, presentation, and facilitation skills
4. Demonstrated leadership skills
5. Proven negotiation skills and significant experience in interacting with regulatory authorities
6. Risk management and problem solving skills
7. Ability to lead, mentor, and develop others for future growth and development8. Demonstrated ability to manage and build relationships with colleagues and regulatory authorities
9. Established credibility with regulatory authorities
EDUCATION AND EXPERIENCE
Advanced Degree or country equivalent in related scientific discipline with a minimum of 10 years experience in RA, including at least 5 years experience managing people. Higher degree/PhD will be an advantage. International experience/exposure preferred
Senior Director Regulatory Affairs
Location:
Deerfield, IL
Description:
The Director, Global Regulatory Affairs, is responsible for strategic direction of the RA function supporting the Global Business of the Medication Delivery Division for a company with an 80% market share in this space.This is a very key roll with responsibilities for strategic direction and performance of the RA function within multiple portfolios, regions, or business units including development, implementation and management of plans and standards. Accountable for relationship and communication with Regulatory Authorities. Accountable for regulatory strategy and vision across multiple businesses or divisions The position will direct and manage a team of regulatory professionals responsible for development of global regulatory strategic plans for new product development, as well as life cycle management of existing products. Responsibilities include management of all US submissions (INDs, NDAs, SNDAs), in addition to oversight and support for all international registrations. The Director will be accountable for relationship and communication with FDA, as well as business management and international affiliates
.1) Guide, direct, and lead a team of regulatory professionals in development of strategic plans and regulatory submissions
2) Foster and maintain relationships with regulatory authorities to facilitate interactions on behalf of Baxter
3) Ensure alignment of regulatory strategy to business strategy across all functional areas
4) Oversee development and negotiation of overall plans regarding safety, efficacy, and quality to assure viability for global or regional registrations
5) Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements
6) Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
7) Act as business liaison to the Business Unit, representing Global Regulatory Affairs on the business management team
8) Develop and manage budget as appropriate
9) Act as primary contact with the regulatory authorities including the planning and leadership of meetings
Job Requirements
QUALIFICATIONS
1. Sound basis of scientific knowledge
2. Expert knowledge of pharmaceutical regulations, standards, current industry practices, and strong experience with interpretation and application.
3. Excellent written and verbal communication, presentation, and facilitation skills
4. Demonstrated leadership skills
5. Proven negotiation skills and significant experience in interacting with regulatory authorities
6. Risk management and problem solving skills
7. Ability to lead, mentor, and develop others for future growth and development8. Demonstrated ability to manage and build relationships with colleagues and regulatory authorities
9. Established credibility with regulatory authorities
EDUCATION AND EXPERIENCE
Advanced Degree or country equivalent in related scientific discipline with a minimum of 10 years experience in RA, including at least 5 years experience managing people. Higher degree/PhD will be an advantage. International experience/exposure preferred
Friday, February 16, 2007
Director of Regulatory Affairs Opening
The Director, Global Regulatory Affairs, is responsible for strategic direction of the RA function supporting the a Global Business Unit for one of our key clients in the pharmaceutical industry. The position will direct and manage a team of regulatory professionals responsible for development of global regulatory strategic plans for new product development as well as life cycle management of existing products. Responsibilities include management of all US submissions (INDs, NDAs, ANDAs, SNDAs), and oversight of international registrations. The Director will be accountable for relationship and communication with FDA, as well as business management and international affiliates.
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Guide, direct, and lead a team of regulatory professionals in development of strategic plans and regulatory submissions
2. Foster and maintain relationships with regulatory authorities to facilitate interactions on behalf of our client
3. Ensure alignment of regulatory strategy to business strategy across all functional areas
4. Oversee development and negotiation of overall plans regarding safety, efficacy, and quality to assure viability for global or regional registrations
5. Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements
6. Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
7. Act as business liaison to the Anesthesia Business Business Unit
8. Develop and manage budget as appropriate
9. Act as primary contact with the regulatory authorities including the planning and leadership of meetings
QUALIFICATIONS
1. Sound basis of scientific knowledge
2. Expert knowledge of pharmaceutical regulations, standards, current industry practices, and strong experience with interpretation and application.
3. Excellent written and verbal communication, presentation, and facilitation skills
4. Proven negotiation skills and significant experience in interacting with regulatory authorities
5. Risk management and problem solving skills
6. Ability to lead, mentor, and develop others for future growth and development
7. Demonstrated ability to manage and build relationships with colleagues and regulatory authorities
8. Established credibility with regulatory authorities
EDUCATION AND EXPERIENCE
Advanced Degree or country equivalent in related scientific discipline with a minimum of 10 years experience in RA, including at least 5 years experience managing people. Higher degree/PhD will be an advantage. International experience/exposure preferred
If you have an interest in this position please send your resume and email expressing your interst to kcorliss@executivesg.com or give me a call at 207-510-6666.
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Guide, direct, and lead a team of regulatory professionals in development of strategic plans and regulatory submissions
2. Foster and maintain relationships with regulatory authorities to facilitate interactions on behalf of our client
3. Ensure alignment of regulatory strategy to business strategy across all functional areas
4. Oversee development and negotiation of overall plans regarding safety, efficacy, and quality to assure viability for global or regional registrations
5. Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements
6. Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
7. Act as business liaison to the Anesthesia Business Business Unit
8. Develop and manage budget as appropriate
9. Act as primary contact with the regulatory authorities including the planning and leadership of meetings
QUALIFICATIONS
1. Sound basis of scientific knowledge
2. Expert knowledge of pharmaceutical regulations, standards, current industry practices, and strong experience with interpretation and application.
3. Excellent written and verbal communication, presentation, and facilitation skills
4. Proven negotiation skills and significant experience in interacting with regulatory authorities
5. Risk management and problem solving skills
6. Ability to lead, mentor, and develop others for future growth and development
7. Demonstrated ability to manage and build relationships with colleagues and regulatory authorities
8. Established credibility with regulatory authorities
EDUCATION AND EXPERIENCE
Advanced Degree or country equivalent in related scientific discipline with a minimum of 10 years experience in RA, including at least 5 years experience managing people. Higher degree/PhD will be an advantage. International experience/exposure preferred
If you have an interest in this position please send your resume and email expressing your interst to kcorliss@executivesg.com or give me a call at 207-510-6666.
What is the goal of my blog?
This blog will be a place that I can keep my candidates informed of new positions, share the exciting new of my clients and publish information important to those working in Regulatory Affairs.
Who is Katie Corliss?
I am the Executive Director of the Life Sciences Practice for the Executive Search Group. I am proud to work with a dedicated team of professionals the strive everyday to meet the needs of our clients and bring great opportunities to our candidates.
I specialize in recruiting Regulatory Affairs Professionals. I work closely with my clients to understand the needs of their organization. Having a true understanding of the clients’ objectives allows me to be successful in bringing them the regulatory professionals that will help them achieve their goals. I have made it my goal to reach out to dedicated group of regulatory professionals, learn what they do, why the do it, and what they are looking for in their long term career goals. I am then able to see my candidates grow professionally in positions that they enjoy and watch my clients achieve their goals and continue to grow,I am please to have strong relationships with both small up coming biotechs and large multinational pharmaceutical companies and medical device companies.
I bring to ESG a background in healthcare administration that gives me a unique view of the industry and ability to understand the long terms goals my clients have to bring new healthcare solutions to their customers.
I specialize in recruiting Regulatory Affairs Professionals. I work closely with my clients to understand the needs of their organization. Having a true understanding of the clients’ objectives allows me to be successful in bringing them the regulatory professionals that will help them achieve their goals. I have made it my goal to reach out to dedicated group of regulatory professionals, learn what they do, why the do it, and what they are looking for in their long term career goals. I am then able to see my candidates grow professionally in positions that they enjoy and watch my clients achieve their goals and continue to grow,I am please to have strong relationships with both small up coming biotechs and large multinational pharmaceutical companies and medical device companies.
I bring to ESG a background in healthcare administration that gives me a unique view of the industry and ability to understand the long terms goals my clients have to bring new healthcare solutions to their customers.
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