Mediabistro is hiring: Director, Regulatory Writing (Temporary) in San Francisco

Overview

Director, Regulatory Writing (Temporary)

Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. We are committed to creating a company where everyone feels supported and encouraged to give their best.

The Opportunity

Vir Biotechnology is looking for a Regulatory Writing Director (Temporary Staff) who will support all aspects of regulatory submissions writing needs. They will collaborate with senior management and other leads to support consistent documents / messaging within and across programs. This role reports to the SVP, Regulatory and is located in our San Francisco headquarters with an expectation of 4 days per week in office.

What You’ll Do

• Craft clear, accurate, and compliant documents required for regulatory submissions to global health authorities including FDA and EMA (European Medicines Agency).
• Write and edit a wide range of regulatory documents, including clinical trial protocols and amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, regulatory submission dossiers (e.g., NDA, IND, MAA) and summary documents, such as summaries of safety and efficacy.
• Ensure all documentation adheres to relevant regulatory guidelines and standards, such as ICH E3 and ICH M4.
• Analyze complex scientific and medical information, including clinical trial data, and translate it into clear, concise language understandable by both technical and non-technical audiences.
• Work closely with cross-functional teams (e.g., clinical, biostatistics, regulatory affairs, pharmacology, safety) to gather data and ensure comprehensive and accurate documentation.
• Manage writing projects from planning and coordination to submission, including establishing timelines and tracking progress.

Who You Are And What You Bring

• Preferred Bachelor’s Degree in Science or Medical-related field with 15+ years industry experience, Master’s Degree with 13+ years industry experience, or PhD with 10+ years industry experience.
• Experience with common regulatory documents such as CSRs, IBs, DSURs, protocols, and clinical modules.
• Expert understanding of eCTD structure and the clinical development process, and in-depth knowledge of document-related ICH guidelines and GxPs.
• Involvement with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents), preferably including responses to questions, 120-day safety updates, or other post-submission activities.
• At least 8 years of experience as a writer in biotechnology or equivalent.

Who We Are And What We Offer

The expected hourly range for this position is $94.00 to $131.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.

Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Legal and Equal Employment Opportunity

All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics. This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.

Vir Biotechnology participates in E-Verify for hires based in the United States. External recruiters and agencies are asked not to contact or present candidates directly to our hiring managers or employees.

For more information about candidate privacy, see the Candidate Privacy Notice.

Job function: Other | Industry: Biotechnology Research and Pharmaceutical Manufacturing | Employment type: Temporary

San Francisco, CA