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Medical Device and Combination Products (MDCP) Medical Reviewer Job

Employer
Merck
Location
Rahway NJ
Closing date
Sep 28, 2017

Job Details

Medical Device and Combination Products (MDCP) Medical Reviewer-DRU000683

Description

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.

This position supports safety assessment and reporting within the growing area of Medical Devices and Combination Products (MDCP), and focuses upon determining whether product quality complaints and /or adverse events meet reporting requirements as well as assessing overall impact to device risk management file. Under the direction of the Clinical Safety and Risk Management (CSRM) MDCP Head, the MDCP Medical Reviewer will provide in-line medical safety review of individual cases arising from Merck post-marketing safety and product quality complaints in order to:

- Assess the need for reporting cases to regulatory agencies
- Perform a medical assessment of the case based upon available product safety and quality data as well as the known safety profile
- Provide a justification assessment that will be included as part of the Individual Case Report as necessary.
- Ensure accuracy of relevant components of the product’s device risk management file.
- Ensure compliance with global expedited reporting timelines, which will require consultation with representative(s) from the Merck Manufacturing Division (MMD), Clinical Safety and Risk Management (CSRM) Physician, and others, as appropriate.

The MDCP Medical Reviewer will work closely and collaboratively with colleagues in other Merck departments, including but not limited to: CSRM staff, and Global Safety Case Management. The MDCP Medical Reviewer will be an extended member of the Risk Management Safety Teams (RMSTs) for the products that he/she supports, as well as other sub-teams, as needed. The incumbent will be based at a Merck site in either Rahway (NJ) or Upper Gwynedd (PA).

Qualifications

Education:

- M.D. or D.O.

Required:

- Minimum of 3 years of combined clinical practice and pharmaceutical industry (pharmacovigilance) experience.

Preferred:

- Highly preferred prior medical review and/or case management experience (specific to device case review)
- Experience in device -drug safety, pharmacovigilance and/or risk management
- Basic familiarity with manufacturing and/or MDCP design considerations

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 an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

For more information about personal rights under Equal Employment Opportunity, visit:

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


Job: Drug Safety Surveillance (MD)

Job Title:Principal Scientist, Drug Safety

Primary Location: NA-US-NJ-Rahway

Other Locations: NA-US-PA-Upper Gwynedd

Employee Status: Regular

Travel: Yes, 5 % of the Time

Number of Openings: 2

Company Trade Name:Merck

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

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