Merck Principal Medical Writer, Oncology in Durham, North Carolina
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
The Principal Medical Writer 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 team (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, trials (e.g., pivotal 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 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.
Qualifications, Skills & Experience:
At least 5 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.
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.
*Remote opportunity available
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R46097