Senior Manager/Associate Director Medical Writer

Discover International; Boston (MA); On-site; USD 120,000 - 190,000; Full time

Job summary

Discover International is seeking a Senior/Associate Director Medical Writer to lead regulatory document development across global clinical programs. You will partner with cross-functional teams, shape document strategy, timelines, and submission deliverables while ensuring scientific rigor and regulatory compliance.

This role offers significant ownership, mentorship of other writers, and the chance to influence program decisions that impact patients.

Qualifications

• Bachelor’s degree in a scientific, medical, or writing-related discipline.
• 5+ years of medical writing experience within pharma/biotech.
• Strong experience developing regulatory and clinical documentation for drug development.
• Experience leading multiple deliverables and coordinating writers/external resources.

Responsibilities

• Lead the development of regulatory and clinical documents (protocols, CSRs, IBs, briefing documents, clinical summaries, pediatric plans, responses to health authorities).
• Serve as lead writer and/or oversight for clinical content within regulatory submissions and global dossiers.
• Represent Medical Writing on cross-functional teams and contribute to program governance.
• Develop document strategies, resource plans, and timelines to support milestones.
• Coordinate internal stakeholders, external writers, and vendors to ensure high-quality deliverables.
• Mentor and support other medical writers while promoting standards and best practices.
• Drive quality and consistency across regulatory documentation and submissions.
• Partner with Clinical Development, Regulatory Affairs, Pharmacovigilance, Biostatistics and other functions.

Skills

Medical writing

Regulatory submissions

CTD/eCTD knowledge

Cross-functional collaboration

Mentoring/lead writer

Education

Bachelor’s degree in scientific/medical discipline

Advanced degree preferred

Job description

A growing biopharmaceutical organization is seeking a SM/AD Medical Writer to lead the development of high-quality regulatory documentation across global clinical development programs. This individual will serve as a key medical writing partner to cross-functional teams, helping shape document strategy, timelines, and submission deliverables while ensuring scientific rigor, consistency, and regulatory compliance.

This is an opportunity for an experienced medical writer to take on significant ownership, influence cross-functional decisions, and mentor other writers while contributing to programs that have a meaningful impact on patients.

Key Responsibilities

• Lead the development of complex regulatory and clinical documents, including protocols, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), briefing documents, clinical summaries, pediatric plans, and responses to health authorities.
• Serve as lead writer and/or provide oversight for clinical content within regulatory submissions and global dossiers.
• Represent Medical Writing on cross-functional teams and contribute to program governance and project meetings.
• Develop document strategies, resource plans, and timelines to support regulatory milestones and submissions.
• Coordinate internal stakeholders, external writers, and vendors to ensure high-quality, timely deliverables.
• Mentor and support other medical writers while promoting consistent standards, processes, and best practices.
• Drive quality and consistency across regulatory documentation and ensure deliverables align with applicable regulatory expectations.
• Partner closely with Clinical Development, Regulatory Affairs, Pharmacovigilance, Biostatistics, and other functions to ensure successful execution of submission-related activities.

Qualifications

Minimum Qualifications:

• Bachelor’s degree in a scientific, medical, or writing-related discipline; advanced degree preferred.
• 5+ years of medical writing experience within the pharmaceutical, biotechnology, or related life sciences industry.
• Strong experience developing regulatory and clinical documentation for drug development programs.
• Experience leading multiple deliverables and/or coordinating other writers and external resources.
• Working knowledge of CTD/eCTD structure and regulatory submission requirements.
• Experience working across global markets is a plus.
• Excellent written and verbal communication skills with the ability to present complex scientific information clearly.
• Strong organizational skills and ability to manage multiple priorities and deadlines.

Preferred Qualifications:

• Experience with global and/or country-specific regulatory submissions and post-approval documentation.
• Experience with document management systems, SharePoint, and medical writing templates/standards.
• Familiarity with evolving regulatory guidance and industry best practices.
• Demonstrated ability to provide strategic document planning and cross-functional leadership.
• Experience with vendor management and/or oversight of external medical writers.
• Strong stakeholder management, collaboration, and influencing skills.
• Exceptional attention to detail, quality, accuracy, and compliance.
• Ability to travel occasionally as needed.