Job Description

Position overview

Under minimal guidance of the Director, Business Development Execution Mature Deals and Operations, the incumbent will be accountable for centralized oversight of the Regulatory activities defined by the Global, Regional and Local contracts and arrangements.These arrangements include but are not limited to divestitures, out-licensing, collaborations, public private partnerships, distribution, co-marketing, and authorized generic agreements post business execution integration (Mature Deals).  This role will also provide oversight, and maintenance of the tools to enable the efficient operations for the Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution and GRACS Integration teams to ensure consistency and streamlined execution and maintenance of our Company’s existing and future business partner deals for all deal types.

Where post implementation ongoing relationship is maintained with the business partner, the incumbent will have duty for serving as the point of contact for all alliance management issues including contractual questions related to ongoing GRACS activities.  As required, lead execution and support of ancillary agreement activities including but not limited to Divestitures and Terminations.

Work closely with the Corporate Business Development, our Research & Development Division Global Alliance Management (MGAM) and GRACS Business Development Execution to comprehend the partner agreements and the goals of those agreements post implementation. Provide ongoing Regulatory reporting of status, risks and issues for Senior Leadership on the contractual obligations and commitments of the GRACS organizations including Global, Regional and Local throughout the Integration Team activities and throughout the integration and post integration with the partner.

Work closely across GRACS Stakeholders including but not limited to GRACS Integration Teams, GRACS Business Development to view and link milestones for a single dashboard view across the active divestitures, integrations and alliances to enable the reporting.  Support a centralized Risk and Issue tracking mechanism and tool for GRACS across deals.

Manage the consistency of operations for GRACS Business Development Execution Leads and the GRACS Integration Teams across deals through the development of new and expansion of existing tools to enable a structured and consistent approach across Alliances and Integrations.  Using tools including but not limited to SharePoint, MS Teams etc., standard templates, playbooks, and examples from previous learnings across deals as applicable and via content available from Corporate Business Development, our Research & Development Division Alliance Management and the Integration Management Office.

Work closely with experienced GRACS Functional and Subject Matter Experts (SME) to centralize knowledge in playbook functional area guides, allocated learning experience and other related examples across deal types. Manage the ongoing necessary periodic updates for these critical tools to ensure alignment to current business practices.

Work closely with BDE Leads and GRACS Integration Team to capture post deal execution reflection, learning, feedback and assessment required to update tools and playbooks as a result of the learning to identify gaps and risks, track progress and coordinate ongoing updates of progress to ensure GRACS Leadership is informed as needed.

Work closely with the GRACS Integration Leads to establish processes and tools for GRACS Business Development Execution Close activities.  Create standardized model for continuity and to enable archival of information, efficiency using checklists and communications to enable long term visibility and information availability for the partnership.

Education:

Required: Bachelor’s Degree preferably in technical, business or science.

Required Experience:

At least 8 years in the pharmaceutical industry with at least 5 years in Regulatory/Pharmacovigilance Function or Business Development.

Understanding of regulatory and clinical processes for pharmaceutical products, vaccines and/or biologic products.  Working knowledge of regulatory concepts, requirements, and overall process of product lifecycles

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).

Experience with partnerships, contracts, and agreements

Project Management Professional (PMP) Certification and/or Six Sigma Green or Black Belt desired.

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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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

02/17/2025

*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:R328402