Associate Director, GRACS BD

Merck; North Wales (Montgomery County); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Medical, Dental, Vision coverage

401(k) retirement plan

Paid holidays

Sick days

Job summary

Merck is seeking a lead for Global Regulatory Affairs and Clinical Safety (GRACS) to manage regulatory and contract activities for business development transactions, including due diligence, drafting and negotiating master and regulatory agreements, and coordinating cross-functional implementation teams.

The role collaborates with BD, Clinical Research, Legal, and Alliance Management, and requires managing deal-specific GRACS implementation teams and ongoing partner diligence.

Qualifications

• Bachelor's degree required.
• Experience in regulatory affairs, BD, and contracting.
• Strong project management and coordination skills.
• Familiarity with FDA regulations and cross-functional collaboration.

Responsibilities

• Lead GRACS activities across business development lifecycle (strategy, evaluation, due diligence, contracting, implementation).
• Draft, negotiate, and maintain master and regulatory agreements and amendments.
• Coordinate due diligence, assemble cross-functional teams, and manage implementation plans.

Skills

Adaptability

Agreement Management

Budget Management

Business Development

Cross-Functional Project Management

FDA Regulations

Pharmacovigilance

Policy Implementation

Project Management

Education

Bachelor's Degree

Job description

Job Description

The incumbent is responsible for representing Global Regulatory Affairs and Clinical Safety (GRACS) on business development transactions from deal initiation through potential signing and transition execution support. More specifically, this position will manage the GRACS activities for business development stages of strategy, evaluation, due diligence, contracting, and implementation support. The deal types largely reflect, but are not limited to, acquisitions, licensing, and collaborations.

• Throughout the business development lifecycle, the incumbent partners with appropriate functional areas within GRACS as well as Business Development, Clinical Research, Legal, and Alliance Management to support diligence, execution, and management of Business Deals.
• Support the drafting, negotiation, execution, and maintenance of both master agreements as well as regulatory agreements, amendments, side letters, and other contractual forms.
• Coordinates and conducts due diligence on business development activities for all projects with GRACS functional area subject matter experts. Recruits and onboards due diligence team members to the due diligence project, facilitates discussions with GRACS due diligence team members to identify gaps and risks, tracks progress and coordinates GRACS due diligence summary reports, ensures GRACS Leadership is made aware of critical due diligence findings as needed, and liaises with GRACS Portfolio and Prioritization group to support GRACS resource estimation. Responsible for reviewing commercial contracts and collaborating with the Corporate Business Development and GRACS SMEs to negotiate the GRACS-related contract language with the partner.
• Charter and manage deal-specific GRACS implementation teams comprised of representatives from the impacted functions/ processes; responsibility will include (a) utilizing project management tools to drive development of implementation project plans; (b) identifying & ensuring cross-functional alignment of interdependent activities; and (c) driving execution of the plans through to project close-out.
• 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 including contractual questions related to ongoing GRACS activities and as required, lead execution and support of ancillary agreement creation, such as regulatory agreements. Conduct/oversee ongoing relevant partner diligence.
• Support any other work related to BD activities including updating BD projects and contracts within the Business Development Lifecycle Management system.

Education Requirements

• Bachelor's Degree

Required Skills

Adaptability, Adaptability, Agreement Management, Budget Management, Business Development, Change Management, Clinical Leadership, Community Relations, Contract Processing, Cross-Cultural Awareness, Cross-Functional Project Management, Data Management, Employee Training Programs, FDA Regulations, Partner Relationship Management (PRM), Partnership Development, People Management, Pharmacovigilance, Policy Implementation, Project Implementations, Project Management, Project Management Methodology (PMM), Project Management Tools, Project Planning, Project Resource Management {+ 9 more}

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

Requirements

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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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The salary range for this role is $129,000.00 - $203,100.00

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.

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

Employee Status

Regular

Flexible Work Arrangements

Hybrid

Job Posting End Date

09/28/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R417558