Director, Medical Writing Lead

Scope of the role

The Director, Medical Writing is accountable for medical writing deliverables of high visibility, high complexity, and multiple asset programs. This position operates with minimal oversight

• Lead team of medical writers on best practices in medical writing and regulatory submission processes, with a focus on collaboration and professional growth / innovation
• Contribute to design of new operating model for medical writing
• Work closely with the reg digital team to explore and assess new technologies such as generative AI and automation to aid in efficient compilation of regulatory documents

• Accountable for the successful planning and implementation of all clinical and regulatory written components of global regulatory submissions across one or more development programs ensuring submissions adhere to the highest standards and are completed within timelines
• Provide overall oversight, review, and approve study-level documentation required for clinical trials, submission documents and other reports intended for regulatory interaction
• Execute cross-functional process improvement initiatives on document standards, template development, and document process
• Facilitate systems and best-practices for training multidisciplinary colleagues participating in document authorship

• Provide oversight for the quality and compliance of written components to company standards as well as regulatory requirements through oversight of the clinical quality control function

• Collaborate with clinical and regulatory teams to establish optimal interfaces to enable efficient and thorough authorship/revision of key technical documents and oversight of diverse regulatory submission documents to support regulatory filings
• Partner with other cross-functional leadership to ensure rapid identification of risks, issues, and development of potential solutions to maintain filing timelines and quality
• Manage and coordinate budget and resources to ensure on schedule completion of medical writing deliverables, including the identification, selection, and oversight of qualified full- or part-time medical writers, vendors, consultants, or contractors
• Oversee cross-functional collaborations and document review process for the medical writing team
• Represent Medical Writing as ad hoc member on Clinical Development Team (CDT) or Core Team (CT);
  Protocol Review Committee

• Review document templates and standard operating procedures

• Maintain best practices in medical writing (e.g., regulatory style guide) to enhance efficiency, quality, and compliance with industry standards. processes, including documentation standards and timelines
• Maintain up-to-date knowledge of industry trends and regulatory changes and provide oversight to ensure that standards are being applied through review of documents produced by other team members

The role requires an experienced medical writing leader with an undergraduate degree and at least 10 years, or an advanced scientific degree and at least 7 years, of relevant experience in medical writing, the pharmaceutical industry, and/or clinical research. The candidate must have deep expertise in global regulatory submissions, including IND/CTA and NDA/MAA preparation, document strategy, and lifecycle management, with proven experience leading document strategies and submission activities across one or more development programs.

Experience across diverse organizational settings (pharma, biotech, and CRO) is preferred. Success in this role depends on advanced knowledge of global regulatory standards, strong leadership and people management capabilities, the ability to manage multiple complex projects under tight timelines, exceptional communication and influencing skills, and demonstrated expertise in outsourcing and resource management. The candidate must also exhibit strong problem-solving abilities, operational rigor, and native or near-native English proficiency

• Be part of a growing, innovation-dri
  ven company entering new therapeutic areas
• Work on global, high-impa
  ct projects shaping access to cutting-edge specialty medicines
• Collaborate with a diver
  se team of scientific and commercial experts
• Enjoy a high level of autonomy and strategi
  c influence within a global organization
• Opportu
  nities for ca
  re
  er growth, internation
  al exp
  osure, and leadership development