Director, Medical Writing

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 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

Qualifications

• BA 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 role(s).
• Demonstrated success authoring and leading development of clinical and regulatory documents supporting regulatory submissions.
• Experience supporting global regulatory filings including IND and CTA deliverables.
• Strong understanding of drug development, clinical research, and regulatory requirements.
• Experience in immunology, inflammation, autoimmune disease, or related therapeutic areas is desirable.
• Experience in a fast-paced biotechnology environment strongly preferred.
  
  

Knowledge And Skills

• Exceptional scientific writing, editing, and communication skills.
• Strong project management and organizational capabilities.
• Ability to synthesize complex scientific and clinical information into clear and concise documents.
• Experience managing multiple projects simultaneously in a deadline-driven environment.
• Strong collaboration and influencing skills across functions and organizational levels.
  
  

Leadership Competencies

• Strategic and critical thinker with strong execution capabilities.
• Highly collaborative and team-oriented.
• Demonstrates ownership, accountability, and sound judgment.
• Thrives in a dynamic, entrepreneurial biotechnology environment.
• Committed to excellence, continuous improvement, and patient-focused innovation.
  
  

Compensation: We understand that compensation is an important part of considering a new opportunity. Our goal is to be transparent so there are no surprises at the end of the process, and you can feel confident that your offer is both fair and equitable. To support that, we’re sharing our hiring range for this role upfront: typically for the Director level we target $225,000 to $275,000 . The final offer will take into account a number of factors, including your skills, experience, location, market data, and internal equity. Along with a competitive salary, we’re proud to offer a comprehensive benefits package designed to support you both personally and professionally.

Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.