Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.
We believe the success of our colleagues drives the success of our Mission. We have an ongoing commitment to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give at their best, we will collectively deliver outstanding results.
Vir Biotechnology is seeking a Medical Writing Associate Director who will support all aspects of regulatory writing needs. They will collaborate with senior management and other leads to support consistent documents/messaging within and across programs. The Medical Writing Associate Director will support development of Medical Writing's roles and responsibilities in alignment with the company's needs.
Manage or oversee all regulatory writing activities for one or more products within or across therapeutic areas to support company, department, and project team goals with respect to project scope, messaging, timelines, other activity planning, and budgeting/resourcing.
Responsibilities and Learning Opportunities:
- Manage or oversee all regulatory writing activities for one or more products within or across therapeutic areas to support company, department, and project team goals with respect to project scope, messaging, timelines, other activity planning, and budgeting/resourcing.
- Provide regulatory writing strategy for product development with the vision to identify immediate and future needs.
- Ensure efficient preparation and completion of high-quality, accurate, concise, and ICH-compliant medical writing deliverables.
- Collaborate with functional and other cross-functional representatives to develop or improve document planning/writing standards and processes as well as to identify potential areas where Medical Writing may expand its services.
- Organize and lead functional and cross-functional document planning, strategy, adjudication, or other team meetings.
- Point of contact for most Medical Writing needs and topics.
- May manage other medical writers (contract or full-time).
Qualifications and Experience
- Bachelor’s Degree in Science or Medical related field with 12+ years regulatory medical writing experience, Master’s Degree with 10+ years regulatory medical writing experience, or PhD with 7+ years regulatory medical writing experience
- Experience with most of the more common regulatory documents such as CSRs, IBs, DSURs, protocols, and clinical modules. Advantageous to have experience with a broader range of regulatory or process documents, such as plain language summaries, Advisory Committee Meeting support, subject safety narratives, SOPs, and templates.
- 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.
- Preferable to have a solid technology background to support electronic/automated initiatives that result in more efficient and higher quality writing.
- Location: United States Remote
This role may be performed remotely if VIR can support remote work arrangements in the state where you currently reside. This includes most states within the US. If you move forward in the hiring process, VIR recruiters will discuss options with you.
Vir’s compensation and benefits are aligned with the current market and commensurate with the person’s experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all lab essential personnel!
Vir is an equal opportunity employer. We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir 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.