Senior Medical Writer
This is a senior medical writing position that requires scientific knowledge along with clear writing and communication skills. The primary focus is on scientific medical writing, which includes researching, writing and editing protocols, investigator brochures, DSUR annual reports, preparation of abstract and scientific presentations, and supervising external vendor(s) in writing clinical study reports. This includes the ability to summarize data from clinical studies and assist in the development of formats and guidelines for clinical documentation. Responsibilities include representation on cross-functional teams as well as development of internal style standards and guidelines consistent with those for electronic regulatory submissions. Must be flexible with the ability to respond rapidly and effectively to changing priorities and corporate policies in a growing biopharmaceutical company.
Primary Duties and Responsibilities
- With input from other team members (Clinical, Development Operations, Biostatistics, Regulatory Affairs, Drug Safety, Pre-Clinical), the Medical Writer researches, writes, and edits Investigator’s Brochures, DSURs, clinical protocols, clinical study reports (CSRs), and clinical summary documents (such as integrated summaries of efficacy and safety), using data provided and in a format compliant with the governing regulatory agency (EMA, FDA and ICH guidelines) and with electronic submission guidelines.
- Lead applications for Orphan Drug Designations, Fast Track, Breakthrough, etc. including responses to health authorities.
- Manages medical writing aspects including development of the strategy and timelines for document preparation and document review process.
- Acts as liaison between cross-functional department personnel, managing writing projects to ensure that background materials are provided, timelines are communicated, and questions are answered.
- Review work of other functional expert writers for accuracy, quality, focus, and adherence to format and stylistic requirements.
- Facilitates internal review of materials and documents and consolidates comments from internal and external reviewers (adjudication meetings).
- Leads the development of style standards and guidelines for preparation of clinical documents submitted to regulatory agencies.
- Acquires and maintains files of reprints cited in clinical documents.
- Minimum BS/BA degree in science (Masters or PhD preferred) with at least 8 year of experience writing clinical documents including regulatory writing and submission experience in a pharmaceutical/biotech company or CRO.
- Extensive knowledge of English grammar, excellent communication skills with a familiarity with a standard style guide.
- Familiarity with the principles of discovery, preclinical development, and clinical research with oncology experience preferred.
- Ability to interpret and present clinical data and other complex information in a clear and concise manner.
- Knowledge of FDA, EMA and ICH guidelines.
- Self-directed and collaborative while building strong working relationships across multiple departments to finalize documents, including in high-pressure situations.
- Thorough working knowledge of personal computer systems and desktop office applications, including proficiency in MS Word, Excel, and PowerPoint.
Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to eradicate cancer globally. The company’s existing pipeline consists of five development-stage assets including two novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and three targeted therapies against uncontrolled growth signaling pathways.