Director, Medical Writing

All Jobs  >  Director, Medical Writing Merida Biosciences Apply Director, Medical Writing Remote Worker - N/A Apply Description Director, Medical WritingAt 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 ResponsibilitiesMedical Writing LeadershipServe 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 DocumentationAuthor, 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 CollaborationPartner  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 outputsEnsure consistency of scientific messaging and data interpretation across all deliverables. Quality and ComplianceEnsure  documents comply with applicable regulatory requirements, ICH guidelines, GCP standards, and company policies. Maintain high standards of scientific accuracy, quality, consistency, and clarity. Drive efficient review and approval cycles to meet critical development  timelines. Support inspection readiness and audit activities as needed.  Requirements  QualificationsBA or BS in a relevant scientific or healthcare discipline; advanced degree preferred. Minimum of 8 years of medical writing experience within biotechnology, pharmaceutical, or CRO settings, with at least 2 years in leadership...