Director, Global Medical Writing

The Steely Group; Massachusetts; Hybrid; USD 180,000 - 240,000; Full time

Job summary

The Steely Group seeks a Senior Principal Medical Writer to independently write and manage complex clinical study documents such as protocols, master protocols, investigator brochures, and study reports. You will lead cross-functional teams for IND/CTA/NDA/MAA submissions and mentor contractors and junior writers.

This role supports both early and late-stage programs. This role guides content strategy, ensures regulatory compliance with ICH guidelines, and oversees reviews, roundtables, and the

Qualifications

• 10+ years medical writing in regulated life sciences.
• Advanced degree MS or PhD in a scientific field.
• Expert regulatory and clinical document authoring for global submissions (NDA/MAA/IND/CTA).
• Strong communication, organization, and mentoring skills.
• Experience with eCTD templates and regulatory systems.

Responsibilities

• Document Preparation and Management: Lead MW for clinical programs; plan, develop, and implement content strategy; author and manage clinical documents within timelines; ensure quality and regulatory alignment.
• Strategic Communication and Meeting Management: Represent the team on cross-functional submission planning; drive document strategies; lead roundtables; coordinate across functions.
• Technical Knowledge, Skills and Abilities: Implement templates, standards, formats, and systems; maintain knowledge base; drive process improvements; participate in template working groups.
• Other duties and responsibilities as assigned

Skills

Medical writing leadership

Regulatory submissions

Attention to detail

Communication skills

Mentoring/leadership

Education

MS or PhD in a scientific field

PhD highly preferred

Tools

eCTD Starting Point templates

Veeva Vault

MS Office (Word/PowerPoint/Excel)

SharePoint

Smart Sheet

Databases

Please Review

Job description

In this highly visible role, the Senior Principal Medical Writer will be responsible for independently writing and managing complex clinical study-related documents including, but not limited to, clinical study protocols, master protocols, investigator's brochures, and clinical study reports. The individual will lead cross-functional teams in development of these and other IND/ CTA/ NDA/MAA submission and response documents. Additionally, the role involves oversight and mentoring of contractors, consultants, and junior writers as needed. This role supports both early and late-stage development programs and regulatory submissions.

Key Responsibilities:

• Document Preparation and Management (60%) Serve as the MW lead for one or more clinical programs Lead the planning, development, and implementation of content strategy for clinical and regulatory documents in compliance with ICH guidelines, country-specific regulations, and tailored to the intended audience Author and manage the preparation of clinical documents and other assigned tasks within established timelines with the highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes Perform reviews of medical writing deliverables, as well as reviews of statistical analysis plans, tables, figures, and listings, as needed Mentor junior members of the team, providing guidance and expertise in medical writing
• Strategic Communication and Meeting Management (25%) Represent GMW on cross-functional clinical, regulatory, and submission teams and actively participate in NDA/MAA/IND submission planning and documentation Identify and manage risks to document management timelines Drive document strategies and messages in a collaborative way with relevant project team subject matter experts Lead document roundtables, communicate and eliminate issues, etc. Ensure effective coordination across functions in development of documents
• Technical Knowledge, Skills and Abilities (15%) Implementation of templates, standards, formats, styles, systems and best practices Maintain cutting edge knowledge base of current developments in field and related technologies. Incorporate process improvements and changes that align with R&D needs Participate in company-wide initiatives such as leading protocol template working groups or IB standardization across programs
• Other duties and responsibilities as assigned

Required Qualifications:

• Advanced degree (MS or Ph.D.) in a relevant scientific field.
• 10 years medical writing experience working in a regulated, life science environment (pharmaceutical and/or biotechnology)
• Expert knowledge of and experience in authoring regulatory and clinical documents for global submissions, including strong submission experience across ICH regions (NDA, NDS, MAA, IND) with active contribution in the planning and preparation of summary documents
• Experienced and skilled in performing medical literature searches
• Excellent verbal and written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy
• Strong organizational/prioritization skills for the management of multiple concurrent documents
• Knowledge of clinical trial disclosure
• Demonstrated proficiency with eCTD Starting Point templates, Smart Sheet, databases, presentation software (MS Office skills such as Teams, Outlook, Word, Excel, PowerPoint, and SharePoint), Veeva Vault, and Please Review

Preferred Capabilities:

• Ph.D. degree in a science field is highly preferred
• Oncology, immunology, and/or neurology experience is highly preferred