Director/Senior Director – Medical and Scientific Writing

Location
South San Francisco, CA, United States
Posted
Jul 30, 2021
Ref
455081921
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Graphite Bio is a clinical-stage biotechnology company focused on harnessing the power of targeted DNA integration. Graphite Bio uses next-generation CRISPR based technology platforms for developing curative gene correction-based stem cell therapies for serious and life-threatening genetic diseases with inadequate existing treatment options

The Director/Senior Director, Medical and Scientific Writing plays a critical role at Graphite Bio. Reporting to the Head of Translational Medicine, you will work in partnership with a talented and collaborative team across our Research/Pre-Clinical, CMC, Regulatory, Clinical and Quality organizations to author and drive development of key documents in support of our gene therapy programs. You will be empowered to interpret data, formulate messaging and strategize on the development of Clinical and Regulatory documents and designations. Likewise, you will synthesize Non-Clinical/CMC and Clinical data into summaries and reports and will be able to develop key content and messaging about our data and novel platforms. This role will be responsible for the build of critical writing infrastructure and processes at Graphite, including the development of best practices and resources for document management and timelines, template and shell creation, lexicon and document QC, publishing and editing standards. You will also have an opportunity to support scientific communications, including the creation of manuscripts, abstracts and posters for congresses and external publication

What You Will Do:

    • Lead and direct all aspects of critical writing activities within Graphite Bio, working cross-functionally to develop and produce high-quality deliverables such as clinical study protocols, IBs, CSRs, INDs/CTDs/amendments, analysis and development plans, safety updates and annual reports, narratives/summaries, briefing books, and additional Research/Pre-Clinical/CMC, Clinical and Regulatory documents in support of our programs.
    • In partnership with cross-functional teams, critically analyze and interpret non-clinical and clinical data (internal and external) to develop crucial strategy, conclusions and messaging. As needed, perform literature and scientific database searches in support of analyses and development of background summaries.
    • Participate on teams as a key thought leader to develop strategy and approach, ensuring consistency and efficiency with how messaging and documents are built and organized, contributing scientific knowledge and analytical skills.
    • Build a scalable medical and scientific writing infrastructure, with an emphasis on resourcing, that includes developing formats, templates, processes and standards, style guides, workflow and operating procedures. You will collaborate closely with teams to develop realistic timelines to meet writing deliverables and program goals.
    • As needed, collaborate with internal and external authors/vendors in support of development of written deliverables, overseeing operational considerations and ensuring awareness of expectations, milestones, and deliverables.
    • Ensure that document content and style adhere to Graphite Bio guidelines as well as ICH/FDA/EMEA or other appropriate requirements for compliance.

 


What You Will Bring:

 

 

    • Bachelor's/Master's degree or Ph.D./equivalent in a scientific discipline with 5+ years of scientific, medical or technical writing experience
    • Prior work history at a biotech or pharmaceutical company preferred; smaller company environment ideal.
    • A strong background and track record of producing high-quality scientific and medical documents for internal/external distribution, ideally with prior gene therapy or stem cell biology experience and education.
    • A strategic and flexible thinker who is able to translate complex data into clear, understandable, and compelling written summaries, interpretations and positions for multiple audiences.
    • Ability to work, communicate and collaborate with colleagues and external stakeholders as a team-player with transparency in a data-driven, fast-paced and exciting environment.
    • Capability and comfort with prioritizing multiple projects, deliverables and timelines to exercise thoughtful judgment, problem-solving and decision-making. Ability to think ahead and identify opportunities for change and improvement with an emphasis on operations and efficiency.
    • Superior attention to detail and thoroughness related to processes, consistency, grammar, syntax, and scientific accuracy. Prior experience building a scientific and medical writing infrastructure and template repository is a plus.
    • Exceptional computer skills and familiarity with key software and cloud programs for document creation (e.g., Microsoft Office, Adobe, etc.) sharing/editing (e.g., Sharepoint, Graphpad, Tableau, etc.), and data visualization (e.g., Spotfire, etc.).
    • A leader and role model who operates with an entrepreneurial spirit, integrity, independence, transparency, and exemplifies the Graphite Bio core values with a focus on improving the lives of patients and families.

 


Fit with Graphite Bio's culture:

Ability to build strong relationships with co-workers of various backgrounds and expertise

Ability to function at a high level in a team setting whether leading the group or acting as an individual

contributor

Values-based leadership consistent with Graphite Bios' Core Values

Excitement about the vision and mission of Graphite Bio

Flexibility

Integrity

Compensation/ Benefits:

Competitive salary with equity

Health benefits

Graphite Bio is an equal opportunity employer, and all qualified applicants will receive consideration for

employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national

origin, protected veteran status, or disability status, or any other characteristic protected by law.