Merck Specialist, Regulatory Report Coordinator in Upper Gwynedd, Pennsylvania

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Regulatory Report Coordinator works closely with the Regulatory Submission Manager and stakeholders such as Clinical Safety and Risk Management and Regulatory Liaisons to support the creation and project management of routine periodic submission plans.

Primary Activities (include but are not limited to):

  • Responsible for the creation of submission plans in Microsoft Project to ensure correct components and timelines are captured

  • Project and document management of regulatory and safety submission components including the coordination and tracking of contributor authoring , review and quality control utilizing regulatory tracking tools to ensure timely release to Publishing and compliance with Health Authority timelines

  • In collaboration with the Regulatory Submission Manager (RSM), actively participate at planning meetings to ensure accurate and complete submission plans and identify, assess and communicate any risks/ issues that could impact the successful completion of routine submissions

  • Work closely with project teams to develop and implement risk mitigation plans as necessary

  • Authoring of administrative cover letters and forms to support periodic Safety and Regulatory submissions to the FDA or other Agencies as needed

  • Responsible for reviewing and requesting the archiving of regulatory/safety submissions

Education Minimum Requirement:

  • Bachelor’s degree required

Required Experience and Skills:

  • Minimum 1 year work experience with a focus on project management

  • Strong document management and organizational skills

  • Proven leadership skills, initiative and ownership of deliverables

  • Ability to work effectively in matrix organizational structure

  • Self-starter, fast learner with ability to innovate and perform in a fast-paced team environment

  • Must have excellent written and verbal communication and interpersonal skills

  • Proficient with computer systems (MS Office necessary; Advanced Excel and Word skills preferred) and document management systems (i.e. FirstDoc, Documentum, SharePoint)

Preferred Experience and Skills:

  • A minimum of 1 year experience working within the healthcare/consumer care industry, preferably in a regulatory/safety environment

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .

Search Firm Representatives Please Read Carefully:

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Visa sponsorship is not available for this position.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it’s manifestations.

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Regulatory Affairs Generic

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Other Locations: NA-US-NJ-Rahway

Title: Specialist, Regulatory Report Coordinator

Primary Location: NA-US-PA-Upper Gwynedd

Requisition ID: REG003966