We are seeking an experienced Medical Writing Manager / Lead to oversee the planning, coordination, and delivery of key regulatory and scientific documents. The role involves collaboration with cross-functional teams, management of multiple projects, and a focus on delivering high-quality, compliant documentation.
Main Responsibilities
* Oversee the end-to-end management of medical writing projects, including planning, timeline management, stakeholder coordination, and delivery of final documents.
* Lead the development of a range of documents, including protocol outlines, informed consent forms, clinical study reports, sections of Module 2 of the eCTD, patient-facing materials, lay summaries, registry content, publications, posters, and abstracts.
* Ensure all content is scientifically accurate, clear, and consistent, meeting regulatory and internal quality standards.
* Coordinate with internal teams (clinical, regulatory, biostatistics, data management, patient engagement, project management) and external partners (CROs, KOLs, patient advocacy groups) to gather input and ensure alignment on objectives.
* Conduct quality control checks for accuracy, grammar, formatting, and template compliance across all documents.
* Ensure all documentation complies with applicable regulatory guidelines and company SOPs, and support submission readiness.
* Contribute to process improvement initiatives, including the implementation of AI tools and digital repositories to enhance document development efficiency.
* Maintain accurate records of timelines, milestones, and deliverables, providing regular progress updates to stakeholders.
* Support training and mentoring of junior writers, promoting collaboration and continuous learning within the team.
Requirements
* 5–8 years of medical writing and project management experience in the pharmaceutical, biotech, or related industry.
* Proven experience in a senior or principal medical writing role.
* Bachelor's degree in life sciences, pharmacy, or a related field; an advanced degree (e.g. MSc, PhD) is preferred.
* Fluency in English (spoken and written).
* Strong knowledge of scientific and medical terminology, regulatory guidelines, and clinical trial processes.
* Excellent project management, organizational, and communication skills.
* Ability to work independently and collaboratively in a fast-paced, deadline-driven environment.
* Experience mentoring junior team members is a plus.