Director, GRACS Business Development Execution, Regulatory Affairs

Global Regulatory Affairs And Clinical Safety Business Development

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. These agreements include but are not limited to divestitures, mergers / acquisitions, in-licensing, out-licensing, collaborations, public private partnerships, distribution, co-marketing, and authorized generic agreements. Facilitates the processes, communications, and governance to ensure GRACS contractual obligations and commitments are met while maintaining regulatory compliance.

Work closely with the Corporate Business Development, our Company's Research & Development Division Global Alliance Management (MGAM), Integration Management Office (IMO) and GRACS Business Development to understand the partner agreements and the goals of those agreements throughout the lifecycle post signing.

Responsible for establishing the GRACS Integration or Transition Team (comprised of functional Subject Matter Expert (SME)) through the recruiting and onboarding integration team members upon completion of the due diligence and understanding of the contract execution requirements for the deal.

Following the GRACS Business Development Operating Model, performs all responsibilities of the GRACS Business Development Execution Lead (or Integration Lead for Acquisitions / Mergers / Collaboration or Transition Lead for divestitures) including facilitation of discussions with GRACS SME execution team to identify gaps and risks, track progress and coordinate ongoing updates of progress to ensure GRACS Leadership is informed as needed. Responsible for understanding contracts and working closely with the Corporate Business Development and our Company's Research & Development Division Alliance Management Teams.

Assess GRACS Integration related problem situations to identify causes, gather and process relevant information, generate possible solutions, make recommendations and / or resolve the problem and direct the resolution of complex business problems.

Ensure adherence to the established common network framework for GRACS functional areas to understand / evaluate business partner operations, establish guidelines for working together and leverage differences to create value, share best practices and deliver activities to drive knowledge transfer between GRACS team members. Provide training as necessary on successful partner relationship skills including process, collaboration, communication, and tools.

Develop the functional alliance relationship to support effective business deal execution, engage partners and GRACS applicable personnel to explore the potential challenges of working together, examine differences, develop shared protocols for managing those differences, and establish mechanisms for their day-to-day work.

Work closely with the Mature Deals and Operations team to define, establish, and drive continuous improvement of the Business Process for the pre and post execution phases of Business Development Agreements with focus on how the different GRACS functions and business partners collaborate.

Specific to opportunities where an ongoing relationship is maintained with the business partner, the incumbent will be responsible for serving as the point of contact for all alliance management issues related to ongoing GRACS activities.

The Director may also have people management responsibilities related to oversight of team members in supporting opportunities in a similar manner as described above. Additionally, the incumbent will assume the responsibilities for employee development and management consistent with Company Leadership and Diversity and Inclusion 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 effectively operate in an ambiguous / rapidly changing environment while being quality and compliance oriented. Proven and demonstrated skills in project management and leadership, strategic, proactive, and a creative problem-solver that generates options and drive results in a deadline driven environment. Strong virtual and in person collaboration Demonstrated facilitation and leadership skills. Clear communicator and goal oriented. Comfort and experience building and presenting effective slide presentations with audiences at all levels of the organization. Independent thinker and worker. Highly organized, motivated, and detail-oriented while still able to keep overall "big picture" view of projects and strategies. Demonstrated analytical and data management skills. Experience pulling together abstract milestones and data into centralized management report. Demonstrated ability to lead cross functional teams and facilitate cross functional meeting to achieve a purpose. Strong, demonstrated project management capabilities and skills. Ability to collaborate and manage multiple projects at various stages of the process simultaneously. Ability to communicate messages in a clear and concise manner both verbally and in writing. Experience with change management concepts and execution. Strong proficiency with generating content using all MS Office tools including but not limited to Word, Excel, Power-Point and SharePoint. Some experience creating and modifying MS Teams and MS Project or related tools to manage project timelines and collaboration. Ability to effectively work seamlessly with all levels of personnel. Demonstrated sensitivity and knowledge of Diversity and Inclusion principles

Desired Experience : Experience with Business Development and / or Regulatory strategy and process for partnerships (multiple deal or execution types) preferred. Experience with partnerships, contracts, and agreements Project Management Professional (PMP) Certification and / or Six Sigma Green or Black

Required Skills : Accountability, Biopharmaceutical Industry, Business Processes, Communication, Cross-Functional Teamwork, Decision Making, Detail-Oriented, Diversity and Inclusion (D&I), Divestitures, Employee Training Programs, EU Legislation, In Licensing, Mentorship, Mergers and Acquisitions (M&A), Negotiation, Out Licensing, People Leadership, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Experience, Regulatory Intelligence

Preferred Skills :

The salary range for this role is $169,700.00 - $267,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https : / / jobs.merck.com / us / en / compensation-and-benefits .

You can apply for this role through https : / / jobs.merck.com / us / en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only : We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only : We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully : Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status : Regular

Relocation : N / A

VISA Sponsorship : N / A

Travel Requirements : N / A

Flexible Work Arrangements : Hybrid

Shift : N / A

Valid Driving License : N / A

Hazardous Material(s) : N / A

Job Posting End Date : 10 / 31 / 2025

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