Director, Medical and Regulatory Writing (South San Francisco, CA)
Sutro Biopharma, Inc. is looking for a motivated and talented Director, Medical and Regulatory Writing to join our team.
- Regulatory/Clinical Writer creates documents intended to support Health Authority interactions and filings, such as briefing documents, INDs/ CTAs, and marketing applications. Included in the scope are medical writing activities as well as some CMC technical writing, as necessary.
- Proficient in the principles of scientific writing, conveys messages in a clear and concise manner, while maintaining compliance with global (FDA, EMA, ICH) regulatory expectations for document content.
- Analyzes, interprets, and distills data and other information to author documents.
- Demonstrates subject matter expertise of relevant regulatory requirements and corporate policies to assess document content expectations and identify information gaps or other potential issues. Takes appropriate steps to resolve any identified issues.
- Collaborates with cross-functional colleagues on content authoring, advising the team on regulatory expectations for document content, and leading through comment resolution.
- Independently authors complex documents compliant with relevant internal processes and standards as well as external regulatory guidance. Demonstrates subject matter expertise.
- Provides strategic and operational leadership to direct preparation and completion of documents. Collaborates cross-functionally with subject matter experts to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
- Drives decision making about data presentation strategies to support advance planning of 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, IBs, clinical study reports, clinical summaries for marketing applications, and responses to queries from regulatory authorities.
- Collaborates with the CMC SMEs on generation of CMC-focused sections of briefing documents, DMFs, 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.
- Master’s Degree or PhD, preferably in a life science discipline. Experience in regulatory/clinical writing – minimum 12 years for MS/MA and 10 years for PhD applicants. BS/BA with 15+ years of experience will also be considered.
- Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
- Ability to manage documents of greater complexity and/or variety.
- Ability to multi-task and work effectively under pressure, with strong organizational and project management skills.
- Develops options or possible solutions to resolve complex problems that impact project completion and/or document content strategy. Demonstrates critical and rapid decision-making.
- Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
- Analytic skills. Ability to examine data and formulate reasonable hypotheses.
- Knowledge of how to use 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
- Capable of leading discussions of benefit/risk assessment and regulatory impact of documents and analyses, without guidance.
- 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).
Sound exciting? Apply today and join our team!
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.
Please be advised, inquiries or resumes from recruiters will not be accepted.
Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.
Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro’s platform has led to cytokine-based immuno-oncology therapies, ADCs, vaccines and bispecific antibodies directed at precedented targets in clinical indications where the current standard of care is suboptimal.
The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.
In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.