Director, Regulatory Writing (Temporary) San Francisco, California, United State

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 believe the success of our colleagues drives the success of our mission. 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 position will report to the SVP, Regulatory.

This role 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, and accurate 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 most of the more 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.

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 Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.

For hires based in the United States, Vir Biotechnology participates in E-Verify.

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As set forth in Vir Biotechnology’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to VEVRAA, we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

• A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
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