Friday, July 25, 2008

Thinking of Changing Jobs?

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.

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.

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

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

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.

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 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

AD Regulatory - Consumer Products - OTC

Sr. Supplier Quality Engineer

Chief MSL

AD Regulatory and Project Mgt


Sr. RA Liscensing Specialist

Sr. RA Specialist

Sr. RA Specialist

RA Specialist

RA Specialist

Dir. Reg Affairs - Pharma

RA Publisher
Chicago North

RA Liscensing Specialist

Medical Science Liaison
San Fransisco

RA Manager
Openings in MA, NJ, IL and PA

Director Drug Safety

RA Project Manager

Dir Reg Affairs -Medical Device

RA Specialist -Pharmacueticals
Openings in Submissions, Liscening and Operations