Medical Writer

Q32 BIO is advancing novel therapeutics to treat autoimmune and inflammatory disorders. We aim to deliver life-changing treatments for patients with a variety of diseases for whom no adequate treatment options exist.

With one program in the clinic and others planned within the coming year, we are looking for an experienced Medical Writer to work directly with scientists within the company across disciplines and Clinical/ Regulatory Operations and Regulatory Affairs departments on various regulatory documents (e.g. Investigator Brochures, Nonclinical Study Reports, Annual Reports, CTAs, INDs, and NDAs, specialized Regulatory documents, such as briefing books) as well as being able to summarize data contained within source data for regulatory documents (i.e. study reports and publications).  This position can assume lead scientific writing responsibility on these projects if needed, utilizing both regulatory and medical writing expertise.  This position also may manage external consultants and CROs that assist Q32 with writing requirements.

Additional representative responsibilities will include, but not necessarily be limited to, the following: 

THE POSITION: Medical Writer

 Responsibilities:

• Working with subject matter experts, writes first drafts of investigator’s brochures, annual reports, INDs, IMPDs, and NDAs and other regulatory documents in conjunction with project team input with minimal supervision
• Interprets data as needed, writes, reviews, and/or edits internal and external publications (reports, manuscripts, abstracts, poster presentations, white papers, etc.).
• Drives document writing and review processes within department for individual projects.
• Develops and maintains timelines for document generation, revision, and completion, in collaboration with other project team members and Regulatory Affairs.
• Coordinate and manage review cycles of documents, incorporates team comments, and leads discussions on regulatory document revision and finalization
• Manage outsourced writing projects with minimal supervision.
• Assists in the development and maintenance of SOPs and writing tools, such as templates and style manuals.
• Provides training on writing, templates, SOPs, and writing processes within the department and across departments if needed.
• Contributes to the development of electronic document systems and tools.
• Provides quality control (QC) review of various regulatory and nonclinical documents as needed.
• Takes the initiative to solve problems, exercising sound judgment and appropriate flexibility within a dynamic environment.
• Works effectively with colleagues from other departments in team situations.
• Provides appropriate interfacing and problem solving solutions between nonclinical, clinical and regulatory departments with regulatory document development.

REQUIREMENTS/QUALIFICATIONS:

• D. in a scientifically related discipline (biology, toxicology, pharmacology) or MS with 3-5, or BS 5-10 years of experience
• Extensive experience in nonclinical department setting within the pharmaceutical industry.
• Effective project management of writing projects across multiple programs and projects
• Ability to prioritize and pivot if needed
• Strong communication skills with both internal and external stakeholders
• Ability to work independently in a fast-paced environment with minimal supervision

Please send Resume and Cover letter to info@q32bio.com .