PWe 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. /ppbMain Responsibilities /b /pulliOversee the end-to-end management of medical writing projects, including planning, timeline management, stakeholder coordination, and delivery of final documents. /liliLead 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. /liliEnsure all content is scientifically accurate, clear, and consistent, meeting regulatory and internal quality standards. /liliCoordinate 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. /liliConduct quality control checks for accuracy, grammar, formatting, and template compliance across all documents. /liliEnsure all documentation complies with applicable regulatory guidelines and company SOPs, and support submission readiness. /liliContribute to process improvement initiatives, including the implementation of AI tools and digital repositories to enhance document development efficiency. /liliMaintain accurate records of timelines, milestones, and deliverables, providing regular progress updates to stakeholders. /liliSupport training and mentoring of junior writers, promoting collaboration and continuous learning within the team. /li /ulpbRequirements /b /pulli5–8 years of medical writing and project management experience in the pharmaceutical, biotech, or related industry. /liliProven experience in a senior or principal medical writing role. /liliBachelor's degree in life sciences, pharmacy, or a related field; an advanced degree (e.g. MSc, PhD) is preferred. /liliFluency in English (spoken and written). /liliStrong knowledge of scientific and medical terminology, regulatory guidelines, and clinical trial processes. /liliExcellent project management, organizational, and communication skills. /liliAbility to work independently and collaboratively in a fast-paced, deadline-driven environment. /liliExperience mentoring junior team members is a plus. /li /ul #J-18808-Ljbffr