Description
Sutro Biopharma, Inc. is looking for a Director, Regulatory Affairs 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, advising the team on regulatory expectations for document content while maintaining compliance with global (FDA, EMA, ICH) regulatory expectations for document content. Experience in oncology drug development is 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, 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.
Qualifications:
- Masters /PhD desirable, life sciences preferred.
- 8+ years experience in industry, with 2+ years in Medical 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 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 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.
- 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.
Sound exciting? Apply today and join our team!
Sutro Biopharma, Inc. encourages all colleagues to be fully vaccinated for COVID-19 prior to the first date of employment.
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.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be $215,000 - $245,000 (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.
About Sutro Biopharma
Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, transforming what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience. Sutro has multiple clinical stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FRα)-targeting ADC in clinical studies. A robust pipeline, coupled with high-value collaborations and industry partnerships, validates our continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit www.sutrobio.com.