Vir Biotechnology

Principal Regulatory Writer (Temporary)

Remote - United States · Principal · Contract

No sponsorship$15k-$20kDetected 27 days ago

HRIntellectual PropertyClinical TrialsClinical ResearchPharmacologyFDA RegulatoryResearchAnimal StudiesCommunicationBiostatisticsRegulatory Affairs

About the role

Work closely with cross-functional teams (eg, clinical research and operations, biostatistics, regulatory affairs, pharmacology, safety, etc) to ensure comprehensive and accurate document content
Participate in defining and writing standard operating procedures and best practices for efficient preparation of quality documents
Provide teams with guidance about best practices and industry standards, offer solutions to authoring hurdles, support interaction and understanding across functional areas
Expert understanding of eCTD structure and the clinical development process, and in-depth knowledge of document-related ICH guidelines and GxPs
Vir Biotechnology, Inc. 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.

Experience with all common study-level and submission-level regulatory documents such as CSRs, IBs, DSURs, protocols, and eCTD modules required

This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs.

Craft clear, accurate, and compliant documents required for regulatory submissions to global health authorities including FDA and EMA
Analyze complex scientific and medical information, including clinical trial data, translating it into clear, concise, and accurate language understandable by both technical and non-technical audiences
Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents
Advanced degree in science or medical field is a plus
Proven experience with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents) including responses to health authorities, 90/120-day safety updates, or other post-submission activities required

The expected hourly range for this position is $180.00 to $200.00.
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.

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.

This listing is sourced directly from Vir Biotechnology's careers page and normalized into a canonical job model.