Associate Principal Scientist, CSRM Med Assessment Job
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.
In collaboration with the Clinical Safety and Risk Management (CSRM) Medical Assessment Physician, performs medical assessments of product quality observations / deviations. Works closely with colleagues in Merck Manufacturing Division (MMD) Product Quality and Global Safety & Environment during the investigation of product quality complaint reports and GMP non-compliance events to evaluate potential patient safety impact, prepare written reports and share findings at team meetings.
Safety Surveillance and Risk Management:
Performs primary medical review of serious adverse experience (AE) reports and other AE reports of interest to monitor and describes the safety profile of assigned products; taking an active role in the oversight and development of pharmacovigilance and risk management plans under the overall direction of the CSRM physician/senior management.. Leads preparation regulatory documents and responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for Merck marketed products; strategizes with safety team recommending appropriate data to respond to queries and analyze data.Qualifications
- Undergraduate degree in nursing (BSN), pharmacy, Physician’s Assistant, or other relevant clinical health related field AND Graduate degree in a relevant health related field.
- Graduate degree in nursing (e.g MSN), PharmD, Physician’s Assistant, or other relevant clinical health related field (undergraduate training is flexible with advance degree in medical discipline).
- A minimum of 6 years of professional experience with both clinical and pharmaceutical industry experience required, of which a minimum of 3 years MUST include safety experience (e.g. Pharmacovigilance or Clinical Research) involving analysis of aggregate safety data and authoring of safety documents.
- Excellent writing and communication skills a must. Demonstrated leadership skills in managing programs, processes, and facilitating meetings.
- Problem solving and critical thinking skills.
- Experience in data analysis or the interpretation of adverse experience information is a plus.
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.
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Job: Drug/Dvcs Sfty Survnce (NonMD)
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck