Associate Director, Medical Writing

At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients.

Reporting to the Director, Medical Writing, within Regulatory Affairs, the Associate Director of Medical Writing will be responsible for timely and accurate medical writing deliverables, and effectively collaborate with cross-functional teams. The candidate will ideally have a background in drugs and biologics. We are seeking experienced, enthusiastic, independent medical writers with an aptitude for project management who thrive in high-functioning matrixed teams.

Roles and Responsibilities 

• Ensure documents are planned, developed, managed, reviewed, quality checked, and approved according to mutually agreed timelines with input from all critical stakeholders in accordance with Avidity Regulatory Affairs and Development Team priorities.
• Coordinate and manage review cycles to triage, incorporate, and resolve team comments and lead discussion on document revision and finalization.
• Ensure emerging issues are escalated to critical stakeholders for resolution in a timely and collaborative fashion to maintain momentum and reduce conflict in order to achieve program goals.
• Foster an inclusive and supportive culture where transparency, delivery of results, integrity, and personal accountability are valued.
• Take the initiative to solve problems exercising sound judgment and appropriate flexibility within a dynamic environment.
• Work closely with regulatory strategy leads and regulatory operations teams.
• Ensure the quality and scope of documents is aligned with current regulatory expectations.
• Provide experience-based and innovative solutions to enhance efficiency of document development and identify appropriate opportunities and solutions to expedite high-impact documents.
• Coordinate, write, and compile clinical study reports (CSRs). Requires collaboration with cross-functional team members (e.g., biometrics, clinical operations, clinical development, regulatory) to ensure related documents such as statistical analysis plans and tables, figures, and listings, and study-specific documentation are accurate and provide all required data for a CSR.
• Assist in the development and maintenance of SOPs and writing tools such as templates and style manuals.
• Provide training on medical writing templates, QC procedures, SOPs and document-related processes.
• Provide expertise and training as needed for review tools, systems and processes (i.e., timeline software, EDMS, etc.) for efficient and transparent document development, revision and approval.

Experience and Qualifications

• Bachelor’s degree (PhD/Masters strongly preferred) in life science with 7+ years of experience in clinical research and development, regulatory affairs, or related pharma/biotech industry.
• Extensive experience and knowledge of current Medical Writing best practices.
• Ability to create clear and practical plans for documents and drive to successful completion.
• Demonstrated ability to successfully manage and execute complex projects and timelines in dynamic environment with limited supervision.
• Demonstrated understanding of content expectations for eCTD summary and overview documents applicable to INDs as well as US and EU marketing applications.
• Extensive experience with clinical protocols and clinical study reports, including assembly of full CSR appendices in accordance with ICH.
• Experience with successful global regulatory submissions including INDs, BLA/NDAs and/or MAAs meeting technical standards.
• Experience writing a wide range of clinical/regulatory documents (e.g., clinical protocols, CSRs, IBs, briefing documents, annual reports, designation applications [e.g., US and EU Orphan, FastTrack, Breakthrough, PRIME, PIPs]).
• Expertise in leading the development of critical documents within cross-functional teams, providing clear direction when needed.
• Extensive experience with clinical protocols and clinical study reports, including assembly of full CSR appendices in accordance with ICH.
• Familiarity with statistical analysis.
• Excellent verbal and written communication.
• Excellent project management.
• Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.