Medical Writer
Surrozen, United States
Job Description
Surrozen is a biotechnology company focused on discovering and developing novel regenerative medicines with a focus on unlocking the powerful self-renewal properties of the body through specific control of the Wnt signaling pathway.
Surrozen was founded by five leading-edge scientists: K. Christopher Garcia, Ph.D., Roel Nusse, Ph.D. and Calvin Kuo, M.D., Ph.D. from Stanford University; Claudia Janda, Ph.D. from the Princess Maxima Center for Pediatric Oncology; and Hans Clevers, M.D, Ph.D. from the Hubrecht Institute and Princess Maxima Center in the Netherlands. Each has conducted extensive research on Wnt signaling, with findings that together shape Surrozen’s technology and approach to therapeutic development.
Position Summary
The Principal Medical Writer will be responsible for authoring and revising clinical and regulatory documents for submission to the FDA and other agencies. The principal medical writer will also support other clinical communication efforts including abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals.
Responsibilities
- Prepare Investigational New Drug (IND) applications, amendments, briefing documents, annual reports and other documents to support global product development
- Collaborate with project teams to respond to health authority questions and requests
- Lead the development and authoring of clinical protocols, clinical study reports, investigator brochures, and clinical summaries in support of regulatory filings in collaboration with project teams
- Contribute to strategic publication planning and implementation of publication plans, including working with internal authors to develop and author manuscripts, abstracts, posters and presentations for scientific congresses
- Organize, conduct, and lead cross-functional document development meetings from gathering materials and developing content to facilitating document review meetings and discussions and assuring adherence to electronic submission standards
- Review work of other authors on the project teams for accuracy, quality, focus, and adherence to format and stylistic requirements
- Develop and implement internal processes, procedures, and templates that support efficient and compliant document preparation
Requirements
- Bachelor’s degree with 8 years of medical writing experience required
- Doctorate degree with at least 4 years of regulatory medical writing in a biopharmaceutical setting along with other scientific/technical writing experience preferred
- Experience writing IND/CTA submissions, investigator's brochures, clinical protocols, clinical study reports, periodic safety reports, and informed consent documents
- Familiarity with FDA regulations, ICH guidelines, Good Clinical Practices and the drug development process
- Advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates
- Familiarity with Good Publication Practice for Communicating Company-Sponsored Medical Research
- Familiarity with AMA Style guide and clinical research terminology
- Exceptional written communication skills including the ability to independently interpret and summarize complex results
- Experience writing manuscripts, abstracts, and/or scientific/technical (preclinical/CMC) documents
- Ability to influence and reach compromises cross functionally to produce a quality document
- Expert abilities in Microsoft Word, PowerPoint and Adobe Acrobat
- Ability to independently coordinate and prioritize multiple projects in a fast-paced environment
- Flexible with the ability to learn new medical/clinical therapeutic areas and/or indications quickly
- Strong attention to detail
- Demonstrated leadership capability, good team player characteristics, excellent communication and interpersonal skills, strong project management skills, organized and self-motivated
Benefits
- We offer a dynamic start-up environment and a collaborative, passionate team
- Excellent benefits, including competitive employer contributions
- Stock options
- Paid vacation, sick time and holidays
- Shuttle service to/from Caltrain, BART and the South San Francisco Ferry
- State-of-the-art research facility and onsite gym (see the amenities available at The Cove: http://leasing.covessf.com/toc.cfm)