Senior Medical Writer, Regulatory Affairs

Sutro Biopharma • South San Francisco, CA

24d • $120,000 - $155,000 • Hybrid

About The Position

Sutro Biopharma, Inc. is looking for a Senior Medical Writer who will provide leadership in development and execution of document deliverables intended to support clinical trial applications including Health Authority interactions and filings, protocols, CSRs, INDs/ CTAs, and marketing applications. This successful candidate will be proficient in the principles of scientific writing and will work cross‑functionally, maintaining compliance with global regulatory expectations for document content and advising the project teams accordingly. Experience in oncology drug development is preferred. This role may be performed remotely or onsite, with flexibility based on business needs.

Requirements

• 4+ years’ experience with PhD, PharmD, or MD; 6+ years with Masters; 8+ years with BS/BA (provided degrees are in relevant fields with 2 years of direct experience in regulatory/clinical writing.
• Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
• Experience with independently authoring CSRs, protocols and submission documents, such as IND components and/or NDA components (Integrated Summaries and Clinical Summaries).
• Collaborative organizational skills; demonstrated ability to prioritize multiple projects and timelines.
• Strong analytical skills: ability to understand and interpret complex clinical and scientific data from multiple data sources and formulate those data into a well-thought out and reviewer friendly manner.
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
• Knowledge in the publicly available databases (eg, PubMed, DailyMed, FDA, and EMA sources and guidelines) for literature and information mining to support document content and how to cite such information appropriately.
• Able to consolidate, analyze, interpret, and summarize data from multiple data sources.
• Track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences.
• Demonstrated proficiency with Microsoft Word (above average knowledge) and other relevant software (eg, PowerPoint, Excel, Adobe Acrobat).
• Strong attention to detail; experience with Quality Control and editing of scientific documents.

Nice To Haves

• Experience in oncology drug development is preferred.
• Veeva RIM experience preferred.

Responsibilities

• Independently authors complex documents compliant with relevant internal processes and standards as well as external regulatory guidance.
• Collaborates cross-functionally with subject matter experts to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
• Engages early with project teams and subject matter experts to plan and review tables, listings, and figures for assigned documents.
• Collaborates with Medical functions on authoring of documents intended to support clinical trials including (but not limited to) protocols, investigator brochure’s, clinical study reports, clinical summaries for marketing applications, and responses to queries from regulatory authorities.
• Provide guidance for document development for regulatory writing deliverables, including organization, content, and resource requirements.
• Collaborates with the CMC subject matter experts on generation of CMC-focused sections of briefing documents, DMFs, INDs/CTAs, response documents and technical reports, as necessary.
• Collaborates with the non-clinical subject matter experts on generation of non-clinical focused sections of INDs/CTAs, and technical reports, as necessary.
• Works with Project Management and Regulatory Affairs functions to establish appropriate timelines and identify contingencies for delivery of assigned documents in a timely manner.
• Perform internal document reviews, editing, and QC as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees