The (Senior) Medical Writer is responsible for development of medical writing deliverables that support the clinical regulatory writing portfolio and works with some guidance and oversight to achieve goals. This individual is recognized as a scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation which include but not limited to medical information, clinical writing, and publications. The incumbent is responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program. The incumbent will ensure that strategically aligned communication points are conveyed in medical writing deliverables and that the communication points are consistent across program documentation. He / she will mitigate risk associated with medical writing and disclosure processes by establishing and maintaining Best Practices and SOPs.
Key Duties and Responsibilities:
- Responsible for Clinical protocols and reports, Publication planning and Abstracts
- Responsible for all aspects of publication planning and execution including but not limited to collaboration with authors to generate content for abstracts, posters, orals, and manuscripts that appropriately communicates the scientific significance and value to the target audience (discovery, clinical, health economics, observational research, etc.)
- Responsible for generating and maintaining medical information letters
- Is recognized as a scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation
- Applies knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects
- Represents medical writing in cross-functional teams
- Manage outsourced projects and ensure quality, alignment, and timely completion while staying on track with allocated budgets
- Understand the publication landscape (journals, congresses, readership, etc.) and advise the Publication Team and authors accordingly
- Demonstrate disease state expertise and knowledge of current medical and/or regulatory issues related to the product
- Lead discussions on appropriate publication innovations (enhanced content, etc.) and execute appropriately
- Ensure alignment of publication content with product strategy, communication objectives, and lexicon
- Drive timelines and advance multiple projects simultaneously
- Serve as an internal resource to cross-functional teams regarding compliant publication practices
Additional activities may include:
- Lead critical functional or cross-functional initiatives
- Coordinate with external medical writing vendors as required
Education, Skills and Experience:
- Bachelor’s degree required. Substantial coursework in life sciences, chemistry, physics or related preferred
- Advanced scientific degree preferred
- A minimum of 5 years medical writing experience within the bio pharmaceutical industry or a contract research organization.
- Experience in oncology regulatory writing, Genitourinary Cancer preferred (RCC or Prostate)
- Strong interpersonal and communication skills, both oral and written
- Excellent ability in searching and interpreting medical literature
- Technical aptitude for virtual meetings and virtual conferences
The Company’s lead candidate is tivozanib, an oral, once-daily, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective, long half-life inhibitor of all three VEGF receptors, which AVEO is seeking to develop and commercialize in North America as a treatment for renal cell carcinoma (RCC), hepatocellular carcinoma (HCC) and other cancers. On June 1, 2020, the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for tivozanib as a treatment for relapsed or refractory RCC and assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2021. Tivozanib (FOTIVDA®) is approved by the European Commission for the treatment of adult patients with advanced RCC in the European Union plus Norway, New Zealand and Iceland. AVEO is leveraging or seeks to leverage partnerships to develop and commercialize its pipeline of products and product candidates, including tivozanib in oncology and other indications in various geographies, and ficlatuzumab (HGF MAb) in head and neck cancer and pancreatic cancer. AVEO’s earlier-stage pipeline includes AV-203 (anti-ErbB3 MAb), AV-380 (GDF15 MAb) and AV-353 (Notch 3 MAb) drug candidates being developed for various oncology indications.
Tivozanib, ficlatuzumab, AV-203, AV-380 and AV-353 are investigational drugs and have not yet been approved by the U.S. Food and Drug Administration (FDA).