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Associate Principal Scientist

Merck


Location:
Upper Gwynedd, PA
Date:
08/30/2017
2017-08-302017-09-29
Job Code:
REG003155
Merck
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Job Details

Job Title: Associate Principal Scientist  - REG003155

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) R4, Associate Principle Scientist position is a broad role encompassing all aspects of regulatory strategy including Chemistry, Manufacturing and Controls (CMC), clinical efficacy, safety and risk management, and labeling.  He/She has direct responsibility for a portfolio of products that generally ranges across all phases of development and includes mature products.  The Associate Principle Scientist reports to a Director in RAI-HQ. 


The Associate Principle Scientist will have responsibility for an assigned portfolio of products.  The individual will have responsibility for leading and strategically driving results on assigned products and projects through alignment and prioritization with Department management and across stakeholders.  


This highly enthusiastic, self-motivated individual functions with a high degree of independence and imparts their knowledge to the department as a whole.  They have demonstrated their ability to think laterally as well as vertically by looking at how issues potentially can have an impact on other functional areas.  Drug development expertise is leveraged internally to provide advice to RAI HQ Liaisons and externally via committee or cross-functional or cross-divisional team representation and consultation.


Specific responsibilities include: 

  • Independently create and drive implementation of a Rest of World (ROW) regulatory strategy for assigned new products to optimize time to approval in collaboration and alignment with the product team.
  • Independently create and drive execution of regulatory strategy to support lifecycle management of In-line (i.e. mature) products.
  • Support for Clinical Trial Applications (CTA’s) in Phase I-III, Product, Registration and Launch (PR&L) filings, and post filing activities.
  • Critically review and provide scientific and regulatory input on background packages for Agency consultation to ensure clarity and comprehensive presentation of issues.
  • Regulatory review of labeling and responsibility for the strategy and release of supplemental safety and efficacy supplements to update the label.
  • Lead, collaborate and communicate with Country Regulatory Leads, Regional Leads, Regional Liaisons, other functional areas within Global Regulatory Affairs and Clinical Safety, MRL and across Divisions with GHH and MMD to ensure alignment around a common set of priorities and objectives for ROW filings and lifecycle management activities.
  • Lead business process space forums and other organizational initiatives and may represent RAI HQ on cross-functional/cross-divisional teams
  • Act as the Global Regulatory Team (GRT) Lead for assigned products 
  • Will have some agency interactions such as facilitating responses to agency queries, Pre-Submission Meetings (PSMs), FDA communications, etc.  



Qualifications

Education:

  • 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 OR A Master’s or other advanced degree with at least 4 years of relevant experience in pharmaceutical industry.

Required:

  • Previous industry experience is required.  
  • Depending upon previous work experience, a new Senior Scientist may require close managerial oversight and guidance as they gain accumulate knowledge and gain exposure to programmatic regulatory issues. 
  • 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 and negotiating skills are required.
  • Demonstrated Leadership skills
  • Strong scientific and analytical skills.
  • Proactive and creative problem solver that generates options, makes effective and timely decisions and resolves conflicts

Preferred:

  • Prior regulatory experience is preferred but not required.


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 NA-US-NJ-Rahway

Employee Status Regular

Number Of Openings 1

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