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Principal Scientist

Merck


Location:
Upper Gwynedd, PA
Date:
08/30/2017
2017-08-302017-09-29
Job Code:
REG003153
Merck
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Job Details

Job Title: Principal Scientist  - REG003153

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 Regulatory Affairs International Headquarters (RAI-HQ) Principal Scientist position is a broad role encompassing all aspects of regulatory strategy, including Chemistry, Manufacturing and Controls (CMC), clinical, risk management and labeling. The position has dual responsibilities. The Principal Scientist provides guidance and oversight, leading a group of RAI HQ Liaisons who are responsible for the development and implementation of regulatory strategies for Rest of the World (ROW) countries for their portfolio. These portfolios may include products in any phase of development through registration and/or mature products. The Principal Scientist will also have their own portfolio of product(s). The individual will have responsibility for strategically driving results on assigned products and projects through collaboration and alignment with stakeholders. The position reports to the Therapeutic Area Lead in RAI-HQ. 

 

This self-motivated individual functions with a high degree of independence and imparts their knowledge not only to their direct reports but also to the department as a whole. His or her drug development expertise is leveraged within the department to provide advice to RAI-HQ Liaisons and further via committee or cross-functional /cross-divisional team representation and consultation.

 

Specific responsibilities include: 

  • Manage individuals who are responsible for product development stages including Clinical Trial Applications
  • (CTAs) in Phase I-III, Product Registration and Launch (PR&L) filings, and post filing activities.
  • Manage individuals that develop and implement regulatory strategy to support lifecycle management of In-line products.
  • Create and drive implementation of the ROW regulatory strategy for their own assigned products.
  • Review and provide scientific and regulatory input on background packages for Agency consultation to ensure clarity and comprehensive presentation of issues. 
  • Provide regulatory review of product labeling. Responsible for the strategy and release of supplementary safety and efficacy supplements to update the label.
  • Collaborate with Regional Liaisons and Country Regulatory Leads and with other functional areas within Global Regulatory Affairs and Clinical Safety, Merck Research Laboratories, and across divisions (Global Human Health and Merck Manufacturing Division) to ensure that a common set of priorities and objectives are developed for ROW filings and for lifecycle management activities.
  • Manage the liaison support process, including resourcing for project assignments, role definition and management of activities for specific products.  
  • Conduct all appropriate HR activities including managing performance, development planning; staffing and related people-management responsibilities for liaisons within areas of responsibility.  
  • Mentor team members and provide guidance on various aspects of Regulatory Affairs and their projects.
  • Lead and drive organizational initiatives on behalf of the RAI-HQ Leadership Team and represent RAI-HQ on cross-functional/cross-divisional teams. 
  • Lead and resolve complex quality and compliance issues·
  • Collaborate and be the point of contact regarding pre-qualification of World Health Organization filings for certain products.

    



Qualifications

Education:

  •  A Bachelor’s Degree in Pharmacy, Biological Science, Chemistry, Nursing or related discipline.

Required: 

  •  A minimum of 8 years or relevant experience in the pharmaceutical industry.
  • The ability to work effectively both independently and in a team environment, good organizational skills, proven ability to balance diverse activities for multiple projects.
  •  Ability to travel internationally when needed.

Preferred: 

  •  Experience in regulatory affairs and/or clinical drug/biologic development is preferred.
  •  Experience with quality and compliance investigations is preferred.
  •  A Master’s Degree in a relevant discipline, with at least 7 years of relevant experience in the pharmaceutical industry, or a Doctoral level Degree (e.g., Ph.D,, M.D.) with a minimum of 6 years of experience. 
  • Prior people management experience.
  • Prior regulatory experience across a diverse portfolio of products.

 

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.

 

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

 

            

            



Job Regulatory Affairs Liaison

Primary Location NA-US-PA-Upper Gwynedd

Other Locations 

Employee Status Regular

Number Of Openings 1

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