Senior Medical Writer

The Senior Medical Writer may require a bachelor’s/master’s degree. Responsible for researching, writing, and editing clinical/statistical reports and study protocols: summarizes data from clinical studies for submission to the Food and Drug Administration (FDA). Being a Senior Medical Writer typically reports to a supervisor or manager. Working as a Senior Medical Writer typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature.

Senior Medical Writer Job Description Template

Our company is looking for a Senior Medical Writer to join our team.

Responsibilities:

  • Perform formal literature searches, and succinctly summarize scientific content for assigned projects;
  • Collaborate with other staff to resolve complex or unclear situations;
  • Represents medical writing for all clinical studies;
  • Work with team to develop standardization of templates, processes, and tools (SOPs, best practices, templates, style guide);
  • Provide quality control review checks of assigned regulatory documents;
  • Oversee all contract and external medical writing resources;
  • Manage and communicate timelines with team members and senior management to ensure milestones are met;
  • Reviews, synthesizes, and translates medical literature to aid and prepare publications;
  • Writes project reports, edits and formats scholarly products and documents as per required templates;
  • Ensures manuscripts, grants, and award documents meet specific guidelines;
  • Translates findings from systematic reviews into Key Concept and Key Message documents. Drafts and edits manuscripts for clinicians, and faculty team;
  • Collaborates with chair, team, and faculty on the creation and editions of CME products based on systematic reviews and reports;
  • Gathers, interprets, and synthesizes data and presents results in a clear manner;
  • Prepares research and grant proposals, and grant reports according to the specifications of sponsor agencies;
  • Tracks and follows up on status of ongoing projects.

Requirements:

  • IND/NDA submission experience preferred;
  • Ability to communicate with cross-functional team members;
  • Strong understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guideline;
  • MS/MA and 3 years of experience in regulatory writing within the pharmaceutical industry;
  • Has available writing samples;
  • Detail-oriented team player capable of multitasking and prioritizing;
  • Previous medical writing experience from a medical communications or pharma environment across a broad range of projects and/or therapy areas;
  • Strong background in clinical therapeutics and critical analysis;
  • Managed care experience is a plus;
  • Proficient in the use of common Microsoft software programs;
  • Minimum of 3 years’ experience in promotional medical writing in a healthcare communications agency or related background;
  • Approximately 3–4 years’ relevant writing experience;
  • Excellent clinically oriented writing and communications skills;
  • A life sciences degree, ideally combined with a science Masters or PhD;
  • BA/BS in life sciences discipline, English, or job-related field is preferred.