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CONFIRM
NEW
Dec 07 — 2021

Head of Medical Writing

Department:Clinical Development Location: Alameda, CA, USA Job Type: Full-time Reports to: Chief Medical Officer

About the role

The Head of Regulatory Medical Writing will be responsible for overseeing, the direction, planning, authoring, editing, and execution of clinical documents (e.g., CSR, protocols, IBs), regulatory agency briefing documents and response documents, periodic safety reports, as well as marketing applications (BLA, NDA, MAA, NDS), and investigational applications (IND, CTA) for Acepoia’s development programs. Ensure regulatory compliant documents with consistent messaging and use of program-specific technical terms resulting in well written, documents and applications.

Education / Background

  • BA/BSc in scientific or medical discipline; or MBA or MSc with a minimum of 10 years experience
  • 10+ years of medical writing experience for a pharmaceutical or biotech is preferred.

Responsibilities include, but are not limited to

  • Provide Medical Writing support for all assets from pre-IND to BLA.
  • Act as a medical writing subject matter expert, working with clinical development and regulatory team to deliver on medical writing program goals.
  • Manage and directly contribute, as required to the development of a variety of clinical documents for clinical and regulatory purposes, including clinical protocols, clinical study reports, investigator brochures, IND and BLA and other regulatory submissions documents.
  • Manage and directly contribute, as required to the development of publications/presentations of emerging clinical data for Congresses and/or other external stakeholders.
  • Manage and directly contribute, as required to the development of manuscripts summarizing the emerging clinical data.
  • Manage and directly contribute, as required to the planning and coordination of timelines to ensure timely completion of writing projects.
  • Administer timelines and communicate with team stakeholders to maintain awareness of expectations, milestones, and deliverables.
  • Provide support for QC of complex clinical documents.
  • Ensure that the key messages are aligned across protocols, publications, presentations, and regulatory documents.

Position Requirements & Experience Relevant Skills & Experience:

  • Extensive demonstrated experience in the writing of Protocols, Investigator Brochures, Briefing Documents, DSURs, and other Regulatory documents.
  • Experience building a team and supervising medical writers (whether in an Agency, consultants and/or full-time employees).
  • Additional experience directly contributing to and/or supervising the writing of congress presentations and manuscripts is preferred.
  • Experience in resource planning and management experience with virtual teams, employees based in field locations, and functional service providers.

Acepodia is an equal opportunity employer offering a competitive salary and comprehensive package, including stock options, medical care, paid vacation, and holiday time. Title and salary commensurate with experience.

About Acepodia

Acepodia is a clinical-stage biotechnology company developing NK and NK-like gamma delta T cell therapies using our patented ACC (Antibody Cell-Conjugation) technology platform. Using ACC technology, we arm immune cells with antibodies to target and eradicate cancer cells. Our mission is to develop safe, effective, and affordable cell therapies to fight and beat cancers.

Founded in 2017 in the birthplace of biotechnology, the San Francisco Bay Area, CA. Acepodia is venture capital and private equity backed and funded. Our platforms and products aim to address and overcome the major obstacles in cancer therapy: Ability to target low expression of tumor antigens to better prevent tumor escape; Trafficking of effector cells to tumor locations; Activate the immune system to attack cancer cells.
 

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