04 Aug
|
AL Solutions
|
India
04 Aug
AL Solutions
India
Contract Principal Medical Writer
We’re supporting a global clinical research organisation that is looking for an experienced Principal Medical Writer to join on a contract basis.
This is a senior individual contributor role with responsibility for leading complex medical writing projects across clinical development, including protocols, clinical study reports, submission-level documents and scientific publications.
Key responsibilities
- Lead the preparation and coordination of complex clinical study protocols, CSRs and other clinical documents
- Take ownership of submission-level documents
- Act as Medical Writing Lead on large, multi-document projects
- Review clinical study outlines, protocols, SAPs, tables, figures, listings and CSRs
- Ensure scientific integrity, accurate data interpretation and compliance with relevant regulatory guidance
- Produce abstracts, posters, manuscripts and scientific presentations
- Manage multiple assignments in parallel, ensuring delivery against quality, timelines and budget
- Work closely with sponsors, internal project teams and cross-functional stakeholders
- Mentor and guide Medical Writers
- Support audits, bid defences, SOP development and process improvement initiatives
Experience required
- Degree in Life Sciences or a related discipline
- Advanced degree such as an MSc or PhD preferred
- Typically 6+ years of medical writing experience
- At least 3 years’ experience leading medical writing projects
- Strong experience with protocols, CSRs and submission-level documents
- Excellent knowledge of ICH guidelines and regulatory requirements
- Strong understanding of medical and scientific terminology, data analysis and interpretation
- Excellent written and spoken English
- Solid stakeholder management, organisation and time-management skills
- Previous CRO experience is highly desirable
This position would suit an experienced Medical Writer who can operate independently, lead complex deliverables and provide technical leadership across major client programmes.
📌 Contract Medical Writer (India)
🏢 AL Solutions
📍 India