PbMedical Writing Manager – Clinical Regulatory /b /ppbOverview /b /pp Management-level medical writing role leading the development, coordination, and delivery of clinical and regulatory documents supporting global RD programs. /ppbr/ppbKey Responsibilities /b /pulliLead planning, authoring, and review of key clinical regulatory documents (e.g. protocols, IBs, CSRs, paediatric plans, HA responses, submission dossiers). /liliEnsure scientific accuracy, consistency, and compliance with ICH, GCP, and global regulatory standards. /liliProvide strategic input into document planning, submission strategy, and global regulatory timelines. /liliPartner cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Safety, and external stakeholders. /liliReview and quality-check internally and externally authored documents. /liliDevelop and maintain writing standards, templates, and SOPs. /liliMentor and guide medical writers to ensure high-quality output. /liliDrive innovation through the implementation of AI medical writing tools, including governance and quality controls. /liliManage external medical writing vendors, ensuring performance, quality, and process compliance. /li /ulpbr/ppbRequired Background /b /pulliAdvanced degree in Life Sciences (PhD, PharmD, MD, MSc, or equivalent). /lili8+ years’ experience in medical writing within pharma or biotech. /liliProven experience supporting global regulatory submissions. /liliStrong knowledge of ICH, GCP, CTD, and international regulatory frameworks. /liliExperience managing external vendors and outsourced activities. /liliFluent English. /li /ulpbr/ppbHighly Desirable /b /pulliHands-on exposure to AI in regulated document workflows. /liliStrong strategic mindset, attention to detail, and ability to influence cross-functional teams. /liliExperience with document management systems and structured authoring approaches. /li /ulpbr/ppbr/ppIf you’re interested in learning more, feel free to reach out or apply below: /ppbr/pp✉ /pp☎ b+44 (0) /b /p