Job Description

Under minimal guidance of the Senior Director, Business Development Execution, The primary function includes coordinating various GRACS (Global Regulatory Affairs and Clinical Safety) 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, 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 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.

Performs all responsibilities of the GRACS Business Development Execution Lead (or GRACS Integration Lead or Transition lead) including facilitation of discussions with GRACS Functional 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 Research & Development Division Alliance Management Teams

Following the GRACS Business Development Operating Model and related tools, kick off, charter and facilitate deal-specific GRACS Integration Team comprised of functional area representatives from the impacted functions/processes. Responsibility will include (a) utilizing project management tools to drive development of deal implementation project plans; (b) identifying & ensuring cross-functional alignment of interdependent activities; and (c) driving execution of the plans through to project close-out.

Assess GRACS Integration/Transition 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 through the GRACS Business Development Forum.

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, including Ways of Working alignment. Review project details, update and track business development related communications within the Business Development Lifecycle Management system.

Education:

• BS 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 Alliance Management.

• 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 Alliance Management 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 Belt.

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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Requisition ID:R341370