Associate Director, Business Development & Licensing:

Upper Gwynedd Pennsylvania
Requisition ID: REG003568

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. 

Under minimal guidance of the Director, Business Development & Licensing, the incumbent independently assesses, writes, updates and maintains pharmacovigilance business agreements and safety management plans.  This includes exchange of adverse experience data with business partners involved with Merck as part of clinical trial investigations, supply agreements, co-marketing agreements, divestitures and co-promotional agreements.  Negotiates or participates in the negotiations of pharmacovigilance agreements and safety management plans with Merck business partners and Contract Research Organization  (CRO)  partners.  Represents Business Development & Licensing in meetings with internal departments concerning partner agreement reporting responsibilities and process flows.  Identifies and prioritizes workload in order to maintain compliance with departmental and regulatory reporting requirements. 

  1. Independently  organizes, conducts and/or facilitates meetings with business partners and CRO partners in the negotiation of pharmacovigilance business agreements and safety management plans.
  2. Independently assesses, writes, updates, maintains, and stores business agreements according to internal checklists and guidelines as well as company policies and standards.
  3. Independently  organizes, conducts and/or facilitates meetings with business partners, CRO partners and internal stakeholders for the implementation and maintainence activities in our pharmacovigilance business agreements and safety management plans.
  4. Maintains, in collaboration with the Director Business Development & Licensing, the internal guidelines for creating, updating and retention of business partner pharmacovigilance agreements and safety management plans.
  5. Responsible for ensuring that the transfer of legacy data to or from the business partner is appropriate and complete.  Assesses the requirements and liaises with Pharmacovigilance Operations team to ensure appropriate data and/or algorithms are updated appropriately based on the requirements of the agreement.
  6. Collaborates with Director, Pharmacovigilance Business Agreements, to ensure training needs are assessed; creates and implements appropriate training as applicable in regards to new processes for each business agreement.



  • A bachelor’s degree


  • A minimum of seven years pharmaceutical experience or relevant professional experience   
  • Excellent written and verbal communication skills and negotiation skills including ability to write clearly and concisely, and the ability to facilitate meetings
  • Strong conceptual and analytical thinking skills
  • Experience with MS Office (specifically: Excel, Word, PowerPoint) 
  • Demonstrated ability to manage multiple priorities
  • Demonstrated ability to network, collaborate, and communicate across cultures, organizational levels and disciplines
  • Demonstrated ability to make effective and timely decisions 

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. 


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Job: Regulatory Affairs Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications