Merck Principal Medical Writer, Safety Lead (Remote) in Pierre, South Dakota
The Principal Medical Writer Safety Lead is responsible for development and management of medical writing deliverables, with a focus on safety reporting, such as participant narratives, that support the clinical regulatory writing portfolio.Capable of working independently to achieve goals.In this role the Principal Medical Writer Safety Lead:
Is recognized as a significant scientific contributor and subject matter expert in preparation of regulatory clinical documentation, especially safety-related documentation. Strong focus on delivery of participant safety narratives to support CSR, ISS, SUR, RTQ, and narrative writing requests that are the responsibility of Medical Writing.
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., narratives for CSRs), and filings (e.g., safety-related 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.
May have direct reports in addition to overseeing 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.
Promote and adopt new tools and technologies that streamline the deliverables.
Minimum education required:
Degree in the Life Sciences.
Bachelor’s degree with 10+ years; or MS with 8+ years; or PhD with 6+ years of relevant career experience.
Qualifications, Skills & Experience
Minimum of 7 years of experience as a medical writer preparing regulated documents, including safety documents, in the pharmaceutical and/or biotech industry. Ability to prepare, without supervision, core clinical regulatory documents including patient narratives 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), written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development.
Fosters the use of new technology and support innovative approaches to writing, review and QC of documents.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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.
Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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Expected salary range:
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Flexible Work Arrangements:
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Requisition ID: R223394
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