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Executive Director, Chemistry, Manufacturing, and Controls (CMC)

Merck


Location:
West Point, PA
Date:
08/17/2017
2017-08-172017-09-16
Job Code:
REG003099
Merck
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Job Details

Job Title: Executive Director, Chemistry, Manufacturing, and Controls (CMC)  - REG003099

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.
 
The Executive Director CMC Pharma Post-Approval manages a team of CMC professionals supporting a large portfolio of sterile and non-sterile pharmaceutical products. The Executive Director is accountable for CMC regulatory strategy and delivery of high quality post-approval CMC submissions for all marketed products within their assigned portfolio. This lead plays a critical role in negotiating and achieving alignment in partnership with Global Regulatory Affairs Clinical Safety and CMC, Merck Research Labs, Merck Manufacturing Division and Global Human Health to ensure product registrations as maintained in a compliant manner and submissions are delivered that enable sustained product supply to patients.

Responsibilities:

Deliver business objectives through successful and timely delivery of robust and compliant regulatory impact assessments, regulatory strategies and high quality submissions for global post-approval changes to assigned product portfolio.

Negotiate priorities in partnership with stakeholders to enable successful resource planning and allocation to critical projects. Utilize resource models to project future resource requirements and define flexible sourcing options to meet the profit plan.

Evaluate key business challenges within assigned portfolio and collaborate with team members to direct the development of innovative and compliant solutions

Proactively identify, investigate and resolve complex regulatory challenges with potential impact to critical priorities and company objectives. Identify and effectively communicate CMC regulatory strategy, risk, mitigation and overall plan to the Global Regulatory Affairs Clinical Safety, Merck Research Labs, Merck Manufacturing Division management team, and escalate to executive management, as needed

Ensure adherence to regulatory process execution to deliver high quality regulatory CMC submissions, correspondence and Health Authority interactions.

Consider and apply appropriately balanced perspectives (regulatory, business, technical, global, etc.) when making decisions and generating solutions. Influence and drive consensus across divisions to reach rapid, disciplined decision and develop plans to execute.

Manage, coach and mentor CMC staff to manage performance and advance personal and professional development goals. Identify key talent and provide development opportunities that enable growth.

Represent CMC on key executive level meetings, as required. Actively engage as an LT member within the Pharma Post-Approval CMC Team.

Establish strong cross-functional and divisional relationships with key stakeholders, customers and external organizations.
 
 


Qualifications
Education Requirement:
  • Required: Bachelor’s Degree with a minimum of (20) years’ experience in the Pharmaceutical Industry
  • Preferred: Advanced degree with a minimum of (15) years’ experience in the Pharmaceutical Industry

Required Experience:

  • Minimum of (10) years’ experience in CMC Regulatory with progressive experience in leading global programs from pre-approval through post-marketing. 
  • Minimum of (7) years People Management / Leadership experience with proven track record of developing talent.
  • Demonstrated ability to anticipate and influence within and across divisions and in the external business and regulatory environment to identify potential challenges impacting the business and proactively recommend approaches to minimize regulatory risk
  • Recognized as a leader with broad expertise in CMC regulatory strategy and dossier development and life-cycle management. 
  • Experience leading organizational or process related change to drive effective and efficient execution and continuous improvement.
  • Demonstrated ability to recruit, train and develop staff, to motivate others and drive continuous improvement. 
  • Flexibility to operate in a matrix-managed environment and to support staff in that same environment. 
  • 10% Travel 
 
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 - CMC

Primary Location NA-US-PA-West Point

Other Locations 

Employee Status Regular

Number Of Openings 1

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