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Associate Director, Global Regulatory Affairs Lead - Oncology

Merck


Location:
Upper Gwynedd, PA
Date:
08/30/2017
2017-08-302017-09-29
Job Code:
REG003130
Merck
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Job Details

Job Title: Associate Director, Global Regulatory Affairs Lead - Oncology  - REG003130

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 

 

The Associate Principle Scientist, Regulatory Liaison supports products in the oncology therapeutic area as part of a regulatory team.  He/She will have excellent communication and collaboration skills and will work closely with a Global Therapeutic Area Liaison to help develop and implement a global strategy for registration of oncology products and help manage regulatory submissions.  His/her responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions.  The Associate Principle Scientist will report to a Global Regulatory Liaison (Director or Executive Director) and will work with one or more Regulatory Liaison Directors in the oncology therapeutic area). 

The individual will have responsibility for driving results for his/her assigned projects through application of regulatory science and strong communication and analytical skills.   

Specific responsibilities (with coaching and managerial oversight) include but are not limited to:

  • Assisting in Regulatory Agency communications and submissions, including but not limited to: marketing applications (sBLAs), requests for orphan drug and/or breakthrough designations and annual or other periodic reports. The individual will also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests.
  • Implementing strategy to develop Agency background packages and documents associated with Regulatory submissions for marketing applications
  • Communicating with Agencies and attending Agency meetings as needed to assist the Global liaison
  • Participating as an active member on the global regulatory team.  He/She will attend cross functional meetings as required, in collaboration with, and to assist the global liaison.
  • Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy.  Assist the global liaison in authoring of regulatory strategy documents.
  • Collaborating and communicating regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC) as well as other functional areas (e.g. clinical research, safety assessment)
  • Support of Global liaison in label development
  • Assisting with process improvement initiatives
  • Performing regulatory administrative activities as needed in support of the oncology TA


Qualifications

Education Requirement:

  • BA Degree in Pharmacy, Biological Science, Chemistry, Nursing or related discipline.

Required Experience :

  • Bachelor’s degree, preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline required with at least 6 years of relevant experience in the pharmaceutical industry.  Alternatively a Master’s or other advanced degree with at least 3 years of relevant experience in pharmaceutical industry.
  • Prior regulatory experience with any major regulatory agency is required
  • Must have excellent communication skills (both oral and written)
  • Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects. 
  • Flexibility is required.
  • Strong scientific and analytical skills with attention to detail.

Preferred Experience:

  • Experience in clinical drug development is preferred.  Depending upon previous work experience, a new Senior Scientist may require close managerial oversight and guidance as they gain and accumulate knowledge and gain exposure to programmatic regulatory issues.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 

 

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

Visa sponsorship is not available for this position.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            

            



Job Regulatory Affairs Liaison

Primary Location NA-US-PA-Upper Gwynedd

Other Locations NA-US-NJ-Rahway

Employee Status Regular

Number Of Openings 1

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