Job Description

Job Title: Senior Medical Writer Location : Remote Reports to : Vice President, Head of Regulatory Full/Part-Time : Full-Time Regular/Temporary : Temporary 6 months, with possibility of 6-month extension About SonoThera: SonoThera is a venture capital-backed early-stage biopharmaceutical company developing ultra-sound-guided non-viral targeted gene therapies to treat multiple diseases of high unmet need. The Gene Therapy group at SonoThera uses a collaborative, interdisciplinary, and forward-thinking approach to solving many of the current challenges facing genetic medicine discovery and drug development. SonoThera is headquartered in South San Francisco, CA. Job Summary As the Senior Medical Writer, you will oversee the development of high-quality, scientifically accurate documents in support of clinical research, regulatory submissions, and medical communications. You will be responsible for setting strategic direction, ensuring adherence to industry standards, and managing the delivery of high-level documentation for clinical trials, regulatory filings, publications, and other scientific initiatives. Your leadership will drive consistency in writing standards and improve operational efficiency while maintaining the highest ethical and quality standards. What you will accomplish Leadership: Develop and execute comprehensive strategic medical writing strategies for our lead program in collaboration with regulatory affairs, medical affairs, and clinical development teams. Set strategic priorities for medical writing activities across multiple projects, ensuring alignment with organizational goals. Lead and actively contribute to the development, review, implementation, and improvement of departmental processes, policies, standard operating procedures (SOPs), training, and work guidance as applicable. Own relevant medical writing processes; lead medical writing SOP creation/update initiatives. Document Creation and Review : Author, review, and/or manage complex regulatory documents, including investigator brochures (IB), nonclinical reports, clinical study reports (CSRs), and regulatory submissions (IND, NDA, BLA, MAA). Collaborate with the CMO to write clinical protocols. Develop publication strategies and oversee manuscript development for peer-reviewed journals and presentations for scientific conferences. Implement and maintain processes to ensure that all documents are scientifically sound, adhere to regulatory guidelines, and meet organizational quality standards. Management: Establish writing standards, processes, and quality metrics. Collaborate with external medical writing vendors and consultants (as applicable). Review and edit documents for clarity, consistency, and accuracy. Scientific Expertise: Maintain a deep understanding of lead indication, including disease pathophysiology, natural history, and current treatment landscape. Stay current with regulatory guidance, clinical trial methodology, and emerging therapeutic approaches Serve as subject matter expert for lead indication and related conditions across the organization Qualifications Desired Qualifications: Advanced degree (PhD, PharmD, MS, or equivalent) in life sciences, medicine, or related field Minimum 8-10 years of scientific medical writing experience, with at least 4 years in neuromuscular diseases or rare diseases preferred Previous experience managing medical writing teams Strong understanding of FDA, EMA, ICH, and other global regulatory requirements Excellent project management and cross-functional collaboration skills Experience writing protocols, clinical study reports, and authoring nonclinical and clinical components in regulatory filings (NDA, BLA, MAA). Strong understanding of clinical trial design, biostatistics, and data interpretation. Excellent written and verbal communication skills, with the ability to explain complex scientific concepts to non-expert stakeholders. Expert knowledge of document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates. Core Competencies: Exceptional scientific writing and communication skills Strategic thinking and business acumen Leadership and team development capabilities Attention to detail and quality focus Ability to work in a fast-paced start-up and deadline-driven environment Strong analytical and problem-solving skills Compensation: The salary range for this temporary position is $55.00 to $75.00 USD hourly. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.

Job Tags

Hourly pay, Full time, Temporary work, Part time, Remote work,

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