Summary of Position:
The successful candidate will be a strong scientist with biopharmaceutical experience who can collaborate with members of cross-functional teams to prepare high-quality protocols, protocol amendments, investigator brochures, synopses, regulatory documents such as INDs and BLAs, clinical publications, and related clinical documents within agreed-upon timelines. Aravive is a fast-paced, small organization and the ability to be productive and successful in an intense and collaborative work environment is critical.
Job Title: Director/Senior Director, Medical Writing
Reports to: SVP Data Sciences
Employment Type: Full-Time
Location: US East Coast (NC preferred)
FLSA Status: Exempt
Date: Fall, 2020
Key Essential Functions:
- Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts, integrating inputs from other team members into a cogent fit-for-purpose whole.
- Participates in scientific communication planning, including development of strategic medical communication plans
- Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
- Manages the corporate EndNote 9 shared bibliographic library
- Manages all aspects of outsourced or internal CSR production and ensures project delivery
- Partners with other clinical team leaders including participation in the review of mock and/or blinded tables, figures, and listings (TLFs), and narrative planning for relevant documents
- Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
- Collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
- Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
- Works closely with QA to maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
- Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
Required Skills & Abilities:
- Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
- Broad experience managing the medical writing responsibilities associated with multiple studies at various stages and across various functional teams
- Ability to work independently with minimal supervision, multi-task, and work effectively under pressure in a virtual R&D organization; adapt to change as needed; possess excellent project management skills; attentive to details
- Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
- Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
- Ability to communicate scientific or medical information in a clear and concise manner
- Track record of increasing responsibility and independence in a similar role in pharmaceutical drug development
- Excellent organization skills with acute attention to detail
- Strong computer skills, including use of EndNote 9 within MS Word for references management
- Bachelor’s degree +8 years, Master’s Degree + 5 years, Doctoral Degree + 2 years of relevant medical writing experience in the pharmaceutical industry, especially writing in oncology; graduate degree (masters or doctoral) preferred
- Title will be commensurate with experience
- Proven successful experience with writing INDs, Clinical protocols, Clinical study reports, Investigator Brochures, regulatory correspondence, and/or NDAs/BLAs and peer-reviewed journal articles
Aravive, Inc. is an Affirmative Action/Equal Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, protected veteran status, national origin, disability, sexual orientation, gender identity, marital status, genetic information or any other characteristic protected by law.
Company Overview: Aravive, Inc. is developing treatments designed to halt progression of life-threatening diseases, including cancer and fibrosis. Our approach draws on novel insights into targeting signaling pathways that drive the activation, migration and invasion of abnormal cells into healthy tissues. The company is based in Houston, Texas, and received support from the Cancer Prevention & Research Institute of Texas (CPRIT). For more information, please visit our website at https://aravive.wpengine.com.
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