Senior Medical Writer (Upper Gwynedd, PA, Rahway, NJ or Boston)
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 Senior Medical Writer (SMW) is a key member of the Medical Writing team. The SMW is responsible for development and management of medical writing deliverables that support the clinical regulatory writing portfolio and works with some guidance and oversight to achieve goals. The SMW will support the Infectious Disease (ID)/Vaccines therapeutic area. Position can be located at Rahway, NJ or Upper Gwynedd, PA locations, or remote based.
In this role the Senior Medical Writer:
- Is recognized as a scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation.
- Applies developing knowledge of regulatory medical writing and the therapeutic area/investigational product to support pipeline projects. Participates as part of the medical writing team in cross-functional teams (either internally or externally).
- Demonstrates competence in writing, editing and reviewing clinical regulatory documents (e.g., protocols, clinical study reports, investigator brochures, and clinical CTD modules) in line with expectations. Interprets data and applies knowledge of regulatory/compliance/scientific requirements to document preparation.
- 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., Protocols and CSRs), and filings (e.g., clinical modules).
- Works collaboratively with colleagues across functions to achieve results.
- Solves problems associated with medical writing scope of work, seeking advice from management and others as needed and exercising negotiation and communication skills with project team members.
- May participate in orientation and coaching of junior team members or contractor writers.
- May participate in initiatives to improve medical writing processes and standards.
- Bachelor’s Degree in the Life Sciences with a minimum of 6 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry OR
- MS Degree in the Life Sciences with a minimum of 3 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry OR
- PhD in the Life Sciences with a minimum of 1.5 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry.
- Ability to prepare, with minimal supervision, a core subset of clinical regulatory documents ( e.g., protocols, clinical study reports, investigator brochures, and clinical CTD modules) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise, and compliant format.
- Participate actively in medical writing and cross-functional project teams.
- 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.
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, 5 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck