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.