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.
- Degree in the Life Sciences
- Bachelor’s Degree with a minimum of 12 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry OR
- MS Degree with a minimum of 10 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry OR
- PhD with a minimum of 6 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry.
- Ability to prepare, without supervision, any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
- A minimum of 2 years experience managing people, projects and/or the work of others.
- Provide leadership of and management for complex documentation projects and project teams of medical writers.
- Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
- Excellent oral (including presentation) and written communication, and project management skills.
- Awareness of pharmaceutical industry needs beyond clinical development.
- Demonstrated experience in process improvement.
- Active involvement in professional organizations.
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.
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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.
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HJ042018, MRMS
Job: Clinical Research - Clin Ops
Other Locations: US; Upper Gwynedd, PA, US; Boston, MA, US
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 7
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark