Reporting to the Vice President of Pharmacovigilance and Medical Writing, the Head of Medical writing is responsible for the leading medical writing activities across clinical programs for Angion, a late-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address acute organ injuries and fibrotic diseases. This is an exciting opportunity for hands-on Medical Writing leader who is a creative, resourceful, integrative thinker working with drug development teams to bring novel pharmaceutical products to patients through planning and preparing a broad range of regulatory documents including marketing applications. The Head of Medical Writing will hire and manage a small team of medical writers and ensure that strategically aligned communication messages are conveyed clearly and consistently in all relevant medical writing deliverables. As the functional lead, this position will lead the development and implementation of medical writing best practices/infrastructure to support the company’s goals
Essential Functions and Duties:
· Lead and direct medical writing activities to support INDs/NDAs across research and clinical programs ensuring appropriate resources are in place to support all medical writing needs to deliver documents within established timelines and budgets
· Independently write critical, complex clinical documents (pivotal phase 3 protocols and reports, IND/NDA submission documents) with minimal input from functional area experts; ensure key messages are clear and consistent across documents
· Independently search scientific literature to place study results in context with other relevant documents
· Prepare briefing books and other critical documents for FDA submission in collaboration with Regulatory Affairs and other key functional groups
· Produce clinical development-related documents that are high-quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal standards
· Effectively contribute to statistical output plan concerning organization and table layout for specific documents
· Lead the development and implementation of Medical Writing infrastructure/tools to maximize quality and efficiency in support of company goals
· Collaborate effectively with colleagues from various functional areas including Clinical Development, Clinical Operations, Statistics and Data Management, Regulatory, Preclinical Development and Program Management as well as external stakeholders Contribute to statistical output plan concerning organization and table layout for a specific document
· 10 years’ experience as a medical or scientific writer within the pharmaceutical industry
· Advanced degree (MS +) in life sciences or equivalent
· Prior hands on experience with marketing applications (BLA, NDA, MAA)
· Experience managing a medical writing group or function
· Ability to interpret and to clearly and succinctly present complex clinical and scientific data.
· Excellent written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy.
· Demonstrated organizational skills, ability to prioritize, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines.
· Ability to work both independently and collaboratively on a cross-functional team; ability to communicate effectively with team members and other stakeholders.
· Knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
· Proficient in use of Microsoft Word, Adobe Acrobat, Microsoft PowerPoint and other standard software used for data analysis and writing of regulatory documents Demonstrated written and oral communication skills and coaching and problem-solving abilities
· Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents