Director, Medical Writing

Merida Biosciences - Director, Medical Writing All Jobs > Director, Medical Writing Merida Biosciences Apply Director, Medical Writing Remote Worker - N/A Apply Description Director, Medical Writing At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases. Merida Biosciences is seeking an experienced and strategic Director, Medical Writing to lead the development of high-quality clinical and regulatory documents that support our advancing pipeline. Reporting to the Senior Director, Regulatory Affairs & Medical Writing , this individual will serve as a key partner to Regulatory Affairs, Clinical Development, Clinical Pharmacology, Clinical Operations, Biostatistics, Pharmacovigilance, Medical, Nonclinical, and CMC teams and ensure that scientifically robust messages are developed and communicated consistently in documents supported by Medical Writing. The Director, Medical Writing will be responsible for authoring, reviewing, and managing a broad range of clinical and regulatory documents while helping establish and scale medical writing processes within a growing biotechnology organization. This role offers the opportunity to[EC1] lead the establishment and refinement of Medical Writing standards that align with Merida’s business needs while contributing to the advancement of innovative therapies for patients with serious diseases. Key

Responsibilities Medical Writing Leadership Serve as the medical writing lead across clinical development programs. Establish and maintain medical writing standards, templates, processes, and document governance practices. Develop timelines and manage document deliverables to support regulatory and clinical milestones. Oversee external medical writing service providers and consultants as needed. Contribute to departmental planning and operational excellence initiatives. Regulatory and Clinical Documentation Author, review, and coordinate preparation of: Clinical study protocols and protocol amendments Investigator's Brochures (IBs) Clinical Study Reports (CSRs) Regulatory meeting requests and briefing packages Additional regulatory documents as assigned Clinical summaries and overviews Responses to regulatory authority questions Oversee redactions of Medical Writing documents subject to public disclosure Cross-Functional Collaboration Partner closely with Regulatory Affairs to support global regulatory submission strategies and health authority interactions. Collaborate with Clinical Development, Clinical Pharmacology, Clinical Operations, Biostatistics, Pharmacovigilance, Medical, Nonclinical, CMC, and Quality teams to develop high-quality documents. Lead document planning and review meetings, ensuring alignment among stakeholders. Review statistical analysis plans and draft statistical outputs Ensure consistency of scientific messaging and data interpretation across all deliverables. Quality and Compliance Ensure documents comply with applicable regulatory