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Associate Vice President, Oncology Therapeutic Area at Merck USA in Rahway, NJ

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Description

Requisition ID: REG003408

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.


This position is a newly created role within the Global Regulatory Oncology Therapeutic Area to lead the strategy that has been identified to support our expanding Oncology portfolio demands.
The AVP, reporting to the Vice President, Worldwide Regulatory Group, is responsible for overseeing the development and implementation of worldwide regulatory strategy for projects within their portfolio. The individual functions with a high degree of independence and directly manages senior level Global Regulatory Leaders (GRLs) across multiple programs. Recognized as an expert in oncology drug development and provides technical and professional leadership to staff handling multiple projects. Therapeutic Area expertise is leveraged internally to provide advice to staff and externally via committee representation and consultation. Recognized internal expert for one or more aspects of regulatory policy or geographic regions.

  • Effectively communicate to (and manage) multiple senior stakeholders in Merck Research Laboratories (MRL) and Global Human Health (GHH) to bring an awareness of the product/program risks. Collaborate and work effectively across boundaries to enable the timely (proactive) resolution of challenges in an innovative manner. Demonstrate leadership capabilities to drive an effective conversation at Senior levels and serve as a delegate of the Therapeutic Area VP.
  • Oversight and management of Global Regulatory Leaders including review of regulatory strategy for Liaison’s respective products.
  • Leading complex programs or components thereof of significant value to the company
  • Applies high-level scientific judgment in a variety of highly complex and unprecedented situations
  • Review and provide final approval of license application subsections.
  • Review and approve communication materials to be used external to Merck such as press releases for accuracy and consistency of message; Review and approve final approval for background packages to ensure clarity and comprehensive presentation of issues.
  • Provide review of labeling; Oversee label negotiations with agencies worldwide as appropriate to obtain and maintain optimal labeling consistent with the company core data sheet.
  • Undertake regulatory due diligence activities for licensing candidate review.
  • Manage the GRL support process, including resourcing for project assignments, role definition and management of activities for specific products.
  • Provides technical and professional leadership to staff and conducts all appropriate HR activities such as managing performance, Development planning; staffing and related people-management responsibilities for liaisons within areas of responsibility.
  • Lead, develop and coach a team of senior level employees to effectively manage programs, franchises and enable rapid and effective decision making through empowerment of individuals. Embody leadership behaviors and develop/coach team to interact and increase effectiveness by enabling clear, and concise communication directly to senior management at Merck.
  • Develop relationship with external stakeholders (industry and regulators) to understand the current landscape and influence internally to implement rigorous, innovative and science-based approaches to our development and submissions.
  • Enhanced business acumen that allows strategic understanding and thinking beyond functional lines that enables driving of decisions and strategies that are innovative and in Merck’s best interest. Ability to leverage experience in a collaborative manner and influence the strategic direction of the company.
  • Serve as MRL/GRACS representative in Senior Mgt teams and engage with the team to articulate a clear vision/direction for the team, thereby driving tough decisions.
Qualifications

Education Requirement: 
  • M.D. or PhD with >12 years relevant drug development experience, preferably with >8 years in Regulatory 
  • M.S. or B.S. with >15 years relevant drug development experience a majority of which was in Regulatory

Required:

  • Regulatory experience required across all phases of drug development required; with therapeutic area experience in Oncology preferred
  • Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies such as the FDA is required.
  • Outstanding interpersonal, communication and negotiation skills are required.
  • Demonstrated leadership experience with building and leading high performing teams; exemplifying corporate and ethical integrity to drives success consistent with company values and priorities.
  • Travel - 30%-40%

Preferred: 

  • Experience with international regulatory authorities outside of USA, such as Europe and Japan
  • Managing portfolios
  • Biologics experience
  • Demonstrated successes/experience in Regulatory policy

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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request tostaffingaadar@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:

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Regulatory Affairs Liaison
Other Locations:
Employee Status: Regular
Travel:
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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