Associate Director, Medical Writing
About The Position
BlossomHill Therapeutics, Inc. is a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to develop innovative small molecule medicines which address significant unmet medical needs in cancer treatment. Founded and led by industry veteran J. Jean Cui, Ph.D., with her proven track record in oncology drug design and development – including three FDA-approved drugs – BlossomHill applies cutting-edge science to address key oncogenic drivers and improve patient outcomes in difficult-to-treat cancers. The company’s lead clinical programs include BH-30643, a first-in-class, macrocyclic, non-covalent, mutant-selective OMNI-EGFRTM inhibitor for the treatment of EGFR-mutated non-small cell lung cancer, BH-30236, a macrocyclic CLK inhibitor for the treatment of relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndrome and BH-501284, a non-covalent, pan-KRAS inhibitor for treatment of diverse KRAS-mutant tumors. For more information visit BlossomHill Therapeutics [http://www.bhtherapeutics.com/].
Requirements
- Bachelor’s degree in a scientific, healthcare, or related discipline; advanced degree (Master’s or PhD) preferred.
- Approximately 8–12 years of relevant medical writing experience in the pharmaceutical, biotechnology, or CRO setting, including substantial experience authoring clinical and regulatory documents such as protocols, CSRs, IBs, and components of IND/CTA/CTA‑equivalent submissions.
- Experience in oncology therapeutic areas (solid tumor and/or hematologic malignancies) strongly preferred.
- Demonstrated ability to interpret and present clinical and non‑clinical data objectively in a clear, concise, and coherent format tailored to regulatory and clinical audiences.
- Excellent organizational and project management skills, with a proven track record of planning, prioritizing, and delivering multiple concurrent writing projects to high standards and tight timelines.
- Ability to work effectively in a team environment, with excellent interpersonal and communication skills to collaborate across levels and functions and with CROs and external consultants.
- Strong technical skills with common software tools (eg, word processing, spreadsheets, document management systems, and online research), including submission‑ready formatting and familiarity with electronic document workflows.
- Excellent oral and written communication skills to effectively interface with internal and external stakeholders.
- Ability to think strategically about document purpose, audience, and messaging, while executing hands‑on writing and driving timelines to completion.
- Proven ability to work effectively with cross-functional teams in a matrix environment and to influence without formal authority.
- Entrepreneurial and passionate; enjoys working in a fast‑paced, small‑company environment and is comfortable operating with limited infrastructure.
- Proactively seeks out, recommends, and implements process and template improvements within the scope of assigned projects.
Responsibilities
- Serve as lead medical writer for assigned studies and programs, planning, preparing, writing, editing, formatting, and finalizing non‑clinical, clinical, and regulatory documents. Documents may include: INDs, CTAs, non‑clinical summaries, clinical protocols, clinical study reports, Investigator Brochures, updates to regulatory submissions, briefing books, annual reports/DSURs, manuscripts, and posters.
- Implement activities related to the preparation of defined documents (storyline development, authoring, facilitating review and approval, and final formatting), ensuring documents meet regulatory and internal standards.
- Coordinate and oversee external medical writing vendors for assigned projects, ensuring delivery against agreed scope, timelines, and quality; escalate vendor performance issues to the Senior Director, Medical Writing as needed.
- Partner with Regulatory Affairs and cross-functional subject matter experts to organize and prepare documents for regulatory health authority submissions, contributing to document strategy, structure, and key messages while aligning with overall program plans set by the Senior Director.
- Represent Medical Writing on project and study teams for assigned programs, advising teams on content and format requirements for key documents and coordinating writing activities (eg, timelines, review cycles, and revision responsibilities).
- Contribute to the development and refinement of templates, style guidelines, and SOPs for clinical and regulatory documentation; may lead specific template or process improvement workstreams under the direction of the Senior Director.
- Ensure final documents adhere to standard operating procedures (SOPs), good clinical practice (GCP), and International Council on Harmonization (ICH) requirements, and support inspection‑readiness of assigned documents and activities.
- Collaborate effectively with Research & Development colleagues, including clinical research, regulatory, safety, biostatistics, clinical operations, translational medicine, and discovery, to ensure alignment and accuracy of clinical and regulatory content.
- Provide guidance and informal mentoring to junior writers and contractors on assigned projects, promoting best practices in medical writing, while formal line management responsibility remains with the Senior Director.
- Provide input to the Senior Director, Medical Writing on operational improvements, tools, and processes to enhance efficiency and quality of deliverables within the Medical Writing function.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
