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Associate Director/Director, Medical Writing

Company

FibroGen, Inc.
Address , Remote
Employment type FULL_TIME
Salary $223,200 - $238,200 a year
Expires 2023-06-26
Posted at 1 year ago
Job Description
APPROVED for REMOTE WORK IN U.S.
Overview:
FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The company is currently developing and commercializing Roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). For more information, please visit
www.fibrogen.com
.
Position Summary:
The Associate Director/Director, Medical Writing, is responsible for leading medical writing activities for innovative small molecule and biologics throughout the lifecycle of the product (IND, NDAs, BLAs). This role is accountable for working closely with cross-functional subject matter experts in Medical, Medical Affairs, Safety, Regulatory Affairs, CMC, Quality, Product development, Manufacturing and Non-clinical research to ensure accurate, complete, and data drive submission documents with the highest quality to meet global health authority expectations. The position will be responsible for planning, execution, and completion of assigned writing projects spanning the lifecycle of FibroGen’s portfolio.
Key Responsibilities:
  • Participate in external industry forums to ensure Fibrogen practices mirror emerging best practice and technologies.
  • Serve as a senior medical writer and department representative for assigned development program or therapeutic area, including providing guidance to less experienced writers or contractors working on a project that they manage.
  • Leads or advises others on complex projects or problems with broad impact and reviews documents written by less experienced or contract medical writers.
  • Independently author a wide variety of clinical/regulatory documents of all types and complexities such as protocols, clinical study reports (all phases), investigator brochures, CTD summaries/overviews, PIPs/PIP modifications, and regulatory responses.
  • Appropriately delegates projects and initiatives to team and identifies potential conflict and proactively takes action to mitigate.
  • Manage or supervise less experienced writers and contractors to ensure the highest quality of medical writing and adherence to document standards.
  • Participate on multiple cross-functional teams (eg, regulatory submission teams, regulatory project teams) and provide guidance on regulatory submission document strategies.
  • Coaches, trains, and provides guidance to less experienced writers or contractors.
  • Serve as submission lead for complex regulatory submissions, with responsibilities including development and management of document timelines.
  • Participate in or lead medical writing and cross-functional process improvement initiatives on clinical document standards, template development, and document processes.
Education and Qualifications:
  • Minimum Bachelor's degree (M.S. or Ph.D. preferred) in a scientific discipline, communications discipline, or equivalent.
  • Experience in providing oversight of third party vendor contracts to ensure on-time and on-budget delivery.
  • Expertise with regulatory document management systems (e.g. Veeva).
  • Minimum 8+ years of experience in a drug development with expertise in biologics and deep experience in product life cycle for marketed products.
  • Experience in submitting a BLA and expertise in commercial product lifecycle (Marketed products) is highly desired. Experience in IND, IMPDs, BLA, MAA, and supporting documentation (i.e Briefing documents).
  • Excellent interpersonal, verbal, and written communication skills.
  • Strong negotiating skills and ability to think creatively and develop creative solutions.
  • Detail-oriented and highly organized.
  • Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally including vendor partners, FDA and other Health Authorities.
  • Works independently and under tight deadlines. Comfort with ambiguity.
SALARY RANGE
$223,200.00-$238,200.00
FibroGen is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender identity/expression, creed, national origin/ancestry, age, alienage or citizenship, status, age, sex, sexual orientation, marital or domestic/civil partnership status, disability, veteran status, genetic information, or any other basis protected by law.FibroGen will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.
At FibroGen we continue to strive to build a diverse and equitable workplace; we share the typical minimum and maximum salary ranges on all job postings. For annual base pay, we typically set standard ranges for positions based on function and level benchmarks. Further, we establish fixed annual bonus targets, expressed at a % of annual base pay, based on level in the organization. Bonus awards are determined based on assessment of individual and corporate goal achievement. All compensation offers of employment are determined by multiple factors including a candidate’s relevant qualifications, work experience, skills, and other factors and may vary from the amounts listed above.
Notice to Recruiters and Search Firms
FibroGen does not accept unsolicited resumes or communications. Contact with a hiring manager or submission or presentation of candidates by recruiters or placement agencies without a current signed agreement with FibroGen will not constitute, in any form, a financial obligation or agreement for recruitment services or placement support or consulting fees.
E-Verify: Notice to all Prospective Employees