Principal Medical Writer, Oncology
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.
The Principal Medical Writer (PMW) is a key member of the Medical Writing team. The PMW is responsible for development and management of medical writing deliverables that support the clinical regulatory writing portfolio and is capable of working independently to achieve goals. In this role the Principal Medical Writer:
- Is recognized as a significant scientific contributor and subject matter expert in preparation of regulatory clinical documentation.
- Applies in-depth knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Represents functional area in cross-functional teams (either internally or externally).
- Produces high-quality and timely documentation in line with expectations. Interprets and applies knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines.
- Leads and manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development (e.g., program level standards), trials (e.g., CSRs), and filings (e.g., clinical modules). Works collaboratively with colleagues across functions to achieve results.
- Solves complex problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve.
- Oversees the work of other medical writers, providing scientific and operational mentorship and coaching in the design, planning, and execution of their assignments. Provides feedback to their managers on development plans and performance reviews.
- Provides leadership for medical writing processes, standards, and innovative initiatives.
- Degree in the Life Sciences.
- Bachelor’s degree with 10+ years; or MS with 8+ years; or PhD with 5+ years of relevant career experience.
- Minimum of 5 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry. Ability to prepare, without supervision, core clinical regulatory documents according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
- 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.
- Successful preparation of Common Technical Document clinical modules.
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: Clinical Research - Clin Ops
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck