Associate Director/Director Regulatory Scientific Writing

Aavantibio, Inc.
Job Description
AavantiBio is a clinical-stage biopharmaceutical company committed to developing and commercializing novel gene transfer and gene editing therapies for the treatment of rare and ultra-rare genetic diseases. The company is rapidly building a diverse portfolio of gene transfer and gene editing therapies to target debilitating genetic diseases for which the unmet medical need is high for which there are typically no approved therapies treating the underlying disease.

Headquartered in Cambridge, MA, with an additional location in Gainesville, FL, AavantiBio is looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene transfer therapy.

AavantiBio is looking for an individual experienced in regulatory scientific writing who will provide leadership to develop and manage clinical and regulatory submission content for products in development to support Investigational New Drug applications, Clinical Trial
Applications and marketing approvals in the US and internationally. The candidate will have the opportunity to build and grow the regulatory scientific writing function developing standards, templates, and bringing in appropriate technology to facilitate writing and team review. They will collaborate closely with regulatory colleagues as well as subject matter experts to write up technical content into regulatory summary documents in support of regulatory submissions. The ideal candidate will have a strong scientific background and experience writing scientific documents as well as clinical documents to support study start up (Investigator Brochure’s, clinical protocols, etc.).

This individual will report into the Chief Regulatory Officer and will be based in office space to be identified by the Company in the Cambridge/Boston area of Massachusetts.

 Responsibilities for this role include but are not limited to:
  • Prepare clinical and non-clinical documents for regulatory submissions, in accordance with team input, with minimal oversight, in order to meet company goals and objectives (documents include but are not limited to clinical and non-clinical submission documents, Investigator Brochure’s, clinical protocols, Investigational New Drug Applications [INDs], Agency briefing packages and response documents, submission summary modules, and other summary reports).
  • Proactively manage writing activities across assigned projects as appropriate, ensuring adherence to the project submission strategy and alignment with business needs.
  • Interpret and apply regulations in the creation of timely and innovative global regulatory submissions.
  • Author deliverables with consideration for regulatory, corporate, departmental, and quality standards. Develop and adhere to authoring practices/systems/tools.
  • Works with regulatory product lead to develop submission framework and timelines.
  • Coordinate the activities of contract writers (on-site or external), provide review and substantive editing of contributions, and mediate resolution of issues.
  • Assist in formulating the framework for key response documents and regulatory submissions, including organization, content, timelines, and resource requirements; may represent regulatory affairs in cross-functional team or task forces that guide planning and execution of key documents and regulatory submissions.
  • Provide leadership on functional teams that address requirements or issues related to document preparation and production.
  • Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives.
  • Supports preparation and revision of internal procedures for continuous improvement
Education, Experience & Skill Requirements:
  • Bachelor’s Degree in Science in biological field or related to pharmaceutical development.
  • Advanced degree in a life science required, e.g. PhD, PharmD.
  • A minimum of 4 years progressively responsible experience in regulatory submission preparation in the biotechnology industry
  • An equivalent combination of relevant education and applicable job experience may be considered.
  • Experience in gene therapy drug development and orphan drug development is a plus.
  • Proven technical writing ability.
  • Knowledge of structure and function of regulatory submission documents to regulatory agencies including FDA, EMA, and other global health authorities to support the conduct of clinical trials and approval of marketing applications (including, but not limited to, Investigational New Drug (IND), Clinical Trial Authorization (CTA), New Drug Application (NDA), and Marketing Authorization Application (MAA).
  • Experience in preparation and authoring of INDs and global clinical trial applications.
  • Ability to work with MS Word and electronic document management systems.
  • Ability to work in a cross-functional development team environment.
  • Excellent scientific/analytical ability.
  • Excellent communication skills (written and verbal).
  • Strong attention to detail and highly organized.
  • Strong skills in presentation of documents, including MS Word.
EQUAL OPPORTUNITY EMPLOYER
AavantiBio is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training
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