Regulatory Project Manager (Rpm), Associate Director

Job Description

The Regulatory Project Manager (RPM) is a key member of our company's Regulatory Planning and Publishing (RPP) organization, which operates within the larger framework of Global Regulatory Affairs, Clinical Safety, and Pharmacovigilance (GRACS), Operations, Process, & Systems (GRACS O.P.S.). The RPM role sits in RPP, Portfolio and Program Management, and is one of several distinct roles that contribute to the efficient management of Regulatory Projects.

Position Description/Summary

The RPM plays a crucial role in guiding and advancing projects by translating global regulatory strategy into actionable plans at the asset level. This individual acts as a Regulatory Project management expert, ensuring alignment and coordination among cross-functional teams to drive successful outcomes. The RPM collaborates closely with the Global Regulatory Liaison (GRL) to support the development of regulatory strategies for various projects.

Key responsibilities of the RPM include providing strong leadership, driving cross-functional teams, and having a deep understanding of regulatory strategy and processes. Additionally, the RPM proactively contributes to the continuous improvement of business processes while fulfilling their project-related duties.

This position may be based in either Rahway, NJ; Upper Gwynedd, PA;

Primary Responsibilities:

• Demonstrates strong project management skills in handling projects of significant complexity within the end-to-end regulatory drug development process. Proactively identifies areas that need Regulatory Project management support and works collaboratively with the team to seek solutions.

• Applies a strategic mindset to support comprehensive strategies that align with organizational goals and regulatory requirements to ensure successful execution.

• Drives cross-functional teams and leads by influence, leveraging effective interpersonal and communication skills to foster collaboration and navigate complexities inherent in drug development projects.

• Leads key regulatory team meetings by developing clearly defined agendas, ensuring appropriate participation, providing valuable project management insights, and following up to drive progress and accountability.

• Coordinates the communication of critical regulatory information to ensure timely and accurate dissemination of regulatory strategy and operational status throughout the team including co-development partners and/or other external partners, as required.

• Identifies, establishes, and manages databases/information sources to track key deliverables and information.

• Provides strong operational leadership by offering scenario and visualization support to drive proactive planning and rapid and informed decision making.

• Monitors and reviews submission activity and agency interactions for business development collaborations (as applicable) under direction of the GRL, flagging critical information for the relevant stakeholders for timely action.

• Serves as a mentor and coach to fellow RPMs and Regulatory Submission Managers (RSM). Shares valuable lessons learned and best practices to positively impact the growth and success of RPP.

• Identifies opportunities for process improvements and embed best practices into supported teams.

Education, Experience, and Skills:

• Experience and knowledge of regulatory drug development required; including the different phases of development and how the various functional areas contribute to a comprehensive regulatory strategy required

• Minimum of five (5) years of experience in project management or a related role required

• Bachelor’s degree required; concentration in a scientific or applied discipline preferred

• Project management certification (PMP) and/or formal coursework/training in project management is preferred

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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, generally Tuesday, Wednesday and either Monday or 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”.

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Expected salary range:

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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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):

Requisition ID:R286609