Principal Medical Writer at Merck Remote

Principal Medical Writer job at Merck. Remote. 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.

Minimum education required:

• 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.

Required experience and skills:

• 5-10 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.

#MRLGCTO #MW20 #eligiblefor NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingen Apply tot his job Apply To this Job