To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Ĭlick here to request this role’s pay range.Įmployees 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). 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. 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. Awareness of pharmaceutical industry needs beyond clinical development.

Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.Įxcellent oral (including presentation) and written communication, and project management skills. 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.īachelor’s degree with 10 years or MS with 8 years or PhD with 5 years of relevant career experience.ĥ-10 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry. Provides leadership for medical writing processes, standards, and initiatives. Provides feedback to their managers on development plans and performance reviews. Oversees the work of other medical writers, providing scientific and operational mentorship and coaching in the design, planning, and execution of their assignments. Solves complex problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve. Works collaboratively with colleagues across functions to achieve results. 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). Interprets and applies knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines. Produces high-quality and timely documentation in line with expectations. Represents functional area in cross-functional team (either internally or externally).

Is recognized as a significant scientific contributor and subject matter expert in preparation of regulatory clinical documentation.Īpplies in-depth knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. In this role the Principal Medical Writer: 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.

Merck medical writer salary