Sutro Biopharma, Inc
Senior Medical Writer, Regulatory Affairs
Sutro Biopharma, Inc, San Francisco, California, United States, 94199
Overview
Sutro Biopharma, Inc. is looking for a Senior Medical Writer who will provide leadership in the development and execution of document deliverables to support clinical trial applications, including Health Authority interactions and filings, protocols, CSRs, INDs/CTAs, and marketing applications. The successful candidate will apply the principles of scientific writing, work cross-functionally, and maintain compliance with global regulatory expectations for document content while advising project teams accordingly. Experience in oncology drug development is preferred. This role may be performed remotely or onsite, with flexibility based on business needs.
Responsibilities
Independently author complex documents compliant with internal processes, standards, and external regulatory guidance.
Collaborate cross-functionally with subject matter experts to ensure clear, factual, effective, and concise presentation of analyses and discussions in assigned documents.
Engage early with project teams and SMEs to plan and review tables, listings, and figures for assigned documents.
Collaborate with Medical functions on authoring documents to support clinical trials, including protocols, investigator brochures, clinical study reports, clinical summaries for marketing applications, and responses to regulatory queries.
Provide guidance for document development for regulatory writing deliverables, including organization, content, and resource requirements.
Collaborate with CMC SMEs on generation of CMC-focused sections of briefing documents, DMFs, INDs/CTAs, response documents, and technical reports, as necessary.
Collaborate with non-clinical SMEs on generation of non-clinical focused sections of INDs/CTAs and technical reports, as necessary.
Work with Project Management and Regulatory Affairs to establish timelines and contingencies for timely delivery of assigned documents.
Perform internal document reviews, editing, and quality control as needed.
Qualifications
4+ years’ experience with PhD, PharmD, or MD; 6+ years with a Master's; 8+ years with BS/BA (provided degrees are in relevant fields with 2 years of direct regulatory/clinical writing experience).
Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
Experience with independently authoring CSRs, protocols, and submission documents (e.g., IND components and/or NDA components such as Integrated Summaries and Clinical Summaries).
Strong organizational skills with demonstrated ability to prioritize multiple projects and timelines.
Strong analytical skills to understand and interpret complex clinical and scientific data from multiple sources and present them in a reviewer-friendly manner.
Excellent interpersonal, active listening, and influencing skills; able to establish and maintain professional working relationships with team members.
Knowledge of publicly available databases (e.g., PubMed, DailyMed, FDA, EMA) for literature and information mining and proper citation of sources.
Able to consolidate, analyze, interpret, and summarize data from multiple sources.
Track record of communicating complex information effectively in writing to diverse scientific and non-scientific audiences.
Proficiency with Microsoft Word (above average) and other software (PowerPoint, Excel, Adobe Acrobat); Veeva RIM experience preferred.
Strong attention to detail; experience with quality control and editing of scientific documents.
Additional Information 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, Sutro Biopharma believes in fostering a culture that is inclusive and values diversity in background and opinions. We hire extraordinary individuals into every position in the company and are committed to the diversity of our team. We do not discriminate on the basis 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.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California locations is $120,000 - $155,000 (not including bonus, equity, and benefits). The final salary will depend on factors including relevant experience and responsibilities.
#J-18808-Ljbffr
Responsibilities
Independently author complex documents compliant with internal processes, standards, and external regulatory guidance.
Collaborate cross-functionally with subject matter experts to ensure clear, factual, effective, and concise presentation of analyses and discussions in assigned documents.
Engage early with project teams and SMEs to plan and review tables, listings, and figures for assigned documents.
Collaborate with Medical functions on authoring documents to support clinical trials, including protocols, investigator brochures, clinical study reports, clinical summaries for marketing applications, and responses to regulatory queries.
Provide guidance for document development for regulatory writing deliverables, including organization, content, and resource requirements.
Collaborate with CMC SMEs on generation of CMC-focused sections of briefing documents, DMFs, INDs/CTAs, response documents, and technical reports, as necessary.
Collaborate with non-clinical SMEs on generation of non-clinical focused sections of INDs/CTAs and technical reports, as necessary.
Work with Project Management and Regulatory Affairs to establish timelines and contingencies for timely delivery of assigned documents.
Perform internal document reviews, editing, and quality control as needed.
Qualifications
4+ years’ experience with PhD, PharmD, or MD; 6+ years with a Master's; 8+ years with BS/BA (provided degrees are in relevant fields with 2 years of direct regulatory/clinical writing experience).
Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
Experience with independently authoring CSRs, protocols, and submission documents (e.g., IND components and/or NDA components such as Integrated Summaries and Clinical Summaries).
Strong organizational skills with demonstrated ability to prioritize multiple projects and timelines.
Strong analytical skills to understand and interpret complex clinical and scientific data from multiple sources and present them in a reviewer-friendly manner.
Excellent interpersonal, active listening, and influencing skills; able to establish and maintain professional working relationships with team members.
Knowledge of publicly available databases (e.g., PubMed, DailyMed, FDA, EMA) for literature and information mining and proper citation of sources.
Able to consolidate, analyze, interpret, and summarize data from multiple sources.
Track record of communicating complex information effectively in writing to diverse scientific and non-scientific audiences.
Proficiency with Microsoft Word (above average) and other software (PowerPoint, Excel, Adobe Acrobat); Veeva RIM experience preferred.
Strong attention to detail; experience with quality control and editing of scientific documents.
Additional Information 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, Sutro Biopharma believes in fostering a culture that is inclusive and values diversity in background and opinions. We hire extraordinary individuals into every position in the company and are committed to the diversity of our team. We do not discriminate on the basis 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.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California locations is $120,000 - $155,000 (not including bonus, equity, and benefits). The final salary will depend on factors including relevant experience and responsibilities.
#J-18808-Ljbffr