Merck
Director, GRACS Business Development Execution, Regulatory Affairs
Merck, Rahway, New Jersey, us, 07065
Director, GRACS Business Development Execution, Regulatory Affairs
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Director, GRACS Business Development Execution, Regulatory Affairs
role at
Merck .
Under the minimal guidance of the Senior Director, Business Development Execution, the incumbent manages and is responsible for the business process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution. The primary function includes coordinating various GRACS functional areas to ensure implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements such as divestitures, mergers/acquisitions, in‑licensing, out‑licensing, collaborations, public private partnerships, distribution, co‑marketing, and authorized generic agreements. The role facilitates processes, communications, and governance to ensure GRACS contractual obligations and commitments are met while maintaining regulatory compliance.
Key Responsibilities
Work closely with Corporate Business Development, MGAM, IMO, and GRACS Business Development to understand partner agreements and goals throughout the lifecycle post signing.
Establish the GRACS Integration or Transition Team (comprised of functional SMEs) through recruiting and onboarding integration team members after due diligence.
Perform responsibilities of the GRACS Business Development Execution Lead (or Integration Lead/Transition Lead) including facilitation of discussions with GRACS SME teams to identify gaps, track progress, and coordinate updates for GRACS Leadership.
Assess GRACS integration problems, gather and process relevant information, generate solutions, recommend actions, and resolve complex business problems.
Ensure adherence to the common network framework for GRACS functional areas to understand business partner operations, establish guidelines, share best practices, and deliver activities to drive knowledge transfer.
Develop functional alliance relationships to support effective business deal execution and manage day‑to‑day interactions with partners and GRACS personnel.
Collaborate with Mature Deals and Operations to define, establish, and drive continuous improvement of Business Process for pre‑ and post‑execution phases of BD Agreements.
Serve as point of contact for all alliance management issues related to ongoing GRACS activities.
Provide people‑management oversight of team members, employee development, and management in alignment with company leadership and diversity principles.
Education
BS Degree preferably in technical, business or science.
Required Experience
At least 12 years in the pharmaceutical industry with at least 5 years in Regulatory/Pharmacovigilance Function or Business Development.
Ability to influence and operate in an ambiguous/rapidly changing environment while being quality and compliance oriented.
Proven project management, strategic leadership, proactive problem‑solving, and results orientation in deadline‑driven environments.
Strong virtual and in‑person collaboration skills.
Demonstrated facilitation and leadership skills.
Clear communicator, goal oriented, with strong presentation skills for all levels.
Independent thinker, highly organized, detail‑oriented, with overall big‑picture perspective.
Analytical and data management skills with proficiency in MS Office tools.
Experience with cross‑functional team leadership and facilitation.
Diversity and inclusion sensitivity.
Desired Experience
Experience with Business Development and/or Regulatory strategy and processes for partnerships.
Project Management Professional (PMP) Certification and/or Six Sigma Green/Black.
Required Skills
Accountability, biopharmaceutical industry knowledge, business processes, communication, cross‑functional teamwork, decision making, detail orientation, diversity & inclusion, divestitures, mentoring, mergers & acquisitions, negotiation, licensing, people leadership, regulatory affairs compliance.
EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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Director, GRACS Business Development Execution, Regulatory Affairs
role at
Merck .
Under the minimal guidance of the Senior Director, Business Development Execution, the incumbent manages and is responsible for the business process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution. The primary function includes coordinating various GRACS functional areas to ensure implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements such as divestitures, mergers/acquisitions, in‑licensing, out‑licensing, collaborations, public private partnerships, distribution, co‑marketing, and authorized generic agreements. The role facilitates processes, communications, and governance to ensure GRACS contractual obligations and commitments are met while maintaining regulatory compliance.
Key Responsibilities
Work closely with Corporate Business Development, MGAM, IMO, and GRACS Business Development to understand partner agreements and goals throughout the lifecycle post signing.
Establish the GRACS Integration or Transition Team (comprised of functional SMEs) through recruiting and onboarding integration team members after due diligence.
Perform responsibilities of the GRACS Business Development Execution Lead (or Integration Lead/Transition Lead) including facilitation of discussions with GRACS SME teams to identify gaps, track progress, and coordinate updates for GRACS Leadership.
Assess GRACS integration problems, gather and process relevant information, generate solutions, recommend actions, and resolve complex business problems.
Ensure adherence to the common network framework for GRACS functional areas to understand business partner operations, establish guidelines, share best practices, and deliver activities to drive knowledge transfer.
Develop functional alliance relationships to support effective business deal execution and manage day‑to‑day interactions with partners and GRACS personnel.
Collaborate with Mature Deals and Operations to define, establish, and drive continuous improvement of Business Process for pre‑ and post‑execution phases of BD Agreements.
Serve as point of contact for all alliance management issues related to ongoing GRACS activities.
Provide people‑management oversight of team members, employee development, and management in alignment with company leadership and diversity principles.
Education
BS Degree preferably in technical, business or science.
Required Experience
At least 12 years in the pharmaceutical industry with at least 5 years in Regulatory/Pharmacovigilance Function or Business Development.
Ability to influence and operate in an ambiguous/rapidly changing environment while being quality and compliance oriented.
Proven project management, strategic leadership, proactive problem‑solving, and results orientation in deadline‑driven environments.
Strong virtual and in‑person collaboration skills.
Demonstrated facilitation and leadership skills.
Clear communicator, goal oriented, with strong presentation skills for all levels.
Independent thinker, highly organized, detail‑oriented, with overall big‑picture perspective.
Analytical and data management skills with proficiency in MS Office tools.
Experience with cross‑functional team leadership and facilitation.
Diversity and inclusion sensitivity.
Desired Experience
Experience with Business Development and/or Regulatory strategy and processes for partnerships.
Project Management Professional (PMP) Certification and/or Six Sigma Green/Black.
Required Skills
Accountability, biopharmaceutical industry knowledge, business processes, communication, cross‑functional teamwork, decision making, detail orientation, diversity & inclusion, divestitures, mentoring, mergers & acquisitions, negotiation, licensing, people leadership, regulatory affairs compliance.
EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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