Manager/senior Manager, Medical Writing

ABOUT US

Invivyd, Inc. (Nasdaq: IVVD) is a commercial-stage company on a mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2. The company’s proprietary INVYMAB™ platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering. INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs) to keep pace with evolving viral threats. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for its first mAb in a planned series of innovative antibody candidates.

THE HEART OF INVIVYD: OUR EMPLOYEES

Our team is motivated by a collective mission-driven sense of urgency that permeates Invivyd’s culture. We make decisions quickly, trust employees in their areas of expertise, and collaborate efficiently. As a result, Invivyd employees are both quick thinkers and motivated doers.

Invivyd is a company comprised of motivated biopharmaceutical experts who are driven to make an impact on public health. Each employee sees working at Invivyd as a once-in-a-lifetime career opportunity to bring differentiated products to the market—for COVID-19, influenza and beyond.  Our company operates as a hybrid company with employees working at our corporate headquarters in Waltham, Massachusetts and remotely. We have employees in over 25 states, with a critical mass in the greater Boston area and many employees in the northeast as well as California.  

Position Title: Manager/Senior Manager, Medical Writing

Position Summary:

Reporting to the Director of Medical Writing, the Manager/Senior Manager of Medical Writing is responsible for authoring regulatory documents throughout the lifecycle of Invivyd’s clinical development programs. This role will work collaboratively with our cross-functional teams and external partners to ensure that regulatory documents generated by Invivyd and third-party vendors meet the highest Good Clinical Practice (GCP), Good Documentation Practices (GDP), patient safety, and quality standards, in accordance with regulatory requirements.

Responsibilities:

• Serve as lead author of assigned documents. Must be able to generate most content independently, collaborating with cross-functional team members to provide further scientific background, analysis, or interpretation according to their respective roles.
• Analyze, interpret, and communicate the results of clinical trials in a scientifically robust, concise, and compelling manner. Identify, understand, and integrate relevant information from the scientific literature and other sources appropriately.
• Lead and manage assigned medical writing projects, including the design, planning, and preparation of clinical documentation. Work collaboratively with the Director and key stakeholders to establish timelines and ensure documents are delivered on time.
• Be recognized as a significant scientific contributor and subject matter expert in the preparation of regulatory clinical documentation in support of the clinical development pipeline. Apply knowledge and experience to ensure regulatory documents are high-quality, scientifically rigorous, consistent with related documents, and provide the appropriate level of detail and placement of content in accordance with regulatory standards and guidelines (ICH, CTD, etc).

Competencies:

• Strong critical thinking/analytical skills.
• Demonstrated mastery of verbal and written English skills in the medical, scientific, and technical writing fields.
• Result driven, with the ability to work independently, initiating and managing projects with minimal oversight.
• Ambitious, enthusiastic, positive, and dedicated to producing quality work.
• Strong organizational, time management, and interpersonal skills.
• Ability to work in a fast-paced environment.
• Excellent communication skills and highly collaborative in both spirit and action.
• Ability to work fully remote, using a variety of technologies (email, chat, video conferencing, etc) to maintain open and transparent communication within and across all departments.

Requirements:

• BS/BA degree in a science or industry-related discipline
• Minimum of 5+ years of experience as a regulatory medical writer in the pharmaceutical R+D environment.
• Able to prepare any type of clinical regulatory document with minimal supervision and in accordance with company SOPs and best practices, including INDs, IBs, protocols, protocol amendments, CSRs, clinical summaries, background packages, and responses to regulatory authorities
• Working knowledge of ICH and other regulatory guidelines and the IND/BLA/NDA process.
• Thorough knowledge/understanding of clinical trial design, methodology, and statistical concepts.
• Excellent high-level, end-user computer skills (eg, word processing, tables, graphics, spreadsheets, presentation, and templates) and Microsoft software suite skills.

At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.

Invivyd is proud to be an equal opportunity employer.