Senior Medical Writer, Regulatory Affairs
Location: South San Francisco, CA
Position type: Full time
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to alter the tumor microenvironment to enhance tumor cell killing. Our company has a growing portfolio of product candidates and currently has three protein therapeutics in clinical development.
- Cabiralizumab (FPA008) – a monoclonal antibody targeting CSF1R in a Phase 1/2 clinical trial in pigmented villonodular synovitis (PVNS) and in a Phase 1a/1b clinical trial in multiple cancers in combination with Bristol-Myers Squibb Company’s PD-1 immune checkpoint inhibitor, Opdivo® (nivolumab)
- FPA144 – a monoclonal antibody targeting FGFR2b in a Phase 1 clinical trial in FGFR2b over-expressing gastric cancer
- FP-1039 – an FGF ligand trap in a Phase 1b clinical trial in mesothelioma
Five Prime has a differentiated target discovery platform and library that we use to rapidly interrogate the entire extracellular proteome in medically relevant in vitro and in vivo models to discover novel targets and drug leads. Our technology has been validated by our growing pipeline and through multiple collaborations with pharmaceutical companies, including Bristol-Myers Squibb, UCB Pharma, S.A. and GlaxoSmithKline across a range of therapeutic areas. FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at www.fiveprime.com.
We are seeking a motivated and ambitious individual to join the Medical Writing group under Regulatory Affairs. The individual will work closely with cross-functional teams and oversee contractors to perform medical writing duties. This position reports to the Vice President of Regulatory Affairs.
Responsibilities will include:
- High quality writing, reviewing and editing preclinical, clinical and CMC regulatory documents including sections of INDs, protocols, amendments, investigator brochures, development safety update reports (DSURs), regulatory briefing documents that conform to domestic and/international regulatory submission and internal document standards.
- Demonstrate a good grasp of scientific and medical content and drug development process with an excellent understanding of regulatory submissions
- Collaborate closely with and manage cross-functional teams to provide draft and final versions of documents that adhere to time-sensitive timelines.
- Attend meetings about document(s) in development.
- Ensure consistency between related documents.
- Participate in the document QC process as needed.
- Develop and maintain medical writing processes e.g. SOPs, working guidelines, templates, etc.
- Coordinate and manage the work of contract medical writers.
- Through professional associations, publications, and/or meetings, maintain knowledge/ understanding of medical and scientific issues related to developing documents.
- Other projects as needed.
- BA/BS degree in Biology or Biochemistry; advanced degree desirable.
- ≥5 years of experience working as a medical writer
- Ability to communicate and write English clearly, concisely, and effectively
- Understanding of key requirements for regulatory submission as stipulated in FDA regulations, practices and ICH guidances
- Basic to intermediate knowledge of biostatistical and clinical research concepts
- Good understanding of the drug and biologic product development process
- Experience in writing preclinical, clinical and/or CMC sections of INDs and BLAs
- Excellent verbal, written, negotiation, influence and interpersonal communication skills
- Ability to work independently with limited supervision
- Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems
- Well-organized; ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents under tight timelines and shifting priorities/demands
- Ability to coordinate, plan and manage communications to enable timely reviews from other authors and reviewers and to function as a collaborative team member
- Strong attention to detail related to consistency, grammar, syntax and scientific accuracy
Please upload your cover letter and resume.