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About the role
Key responsibilities & impact- Draft regulatory documents, including clinical study protocols, reports, and investigator brochures, across various therapeutic areas with minimal supervision
- Prepare complex documents, such as clinical summary CTD documents, under guidance
- Support Bioforum’s medical writing projects by reviewing and editing internal documents
- Ensure compliance with internal training, guidelines, templates, and SOPs for therapeutic area-specific documents
- Collaborate with a US-based pharmaceutical client to produce clinical documents, including study protocols, reports, informed consent forms, and investigator brochures
- Participate in process improvement initiatives and working groups within the medical writing team and global development
- Oversee junior and outsourced medical writers by reviewing their work and mentoring as needed
- Review CSR-related materials, such as statistical analysis plans and TFLs, to confirm appropriate inclusion
- Create plain language documents where required, explaining complex medical or scientific concepts for lay or patient audiences
- Facilitate and lead cross-functional document review meetings, clarify client feedback, and integrate comments effectively
- Review and edit documents and deliverables to ensure quality and accuracy
- Represent the client’s medical writing department in meetings and discussions
- Develop and articulate document strategies and timelines
- Resolve content-related discussions efficiently and succinctly synthesize outcomes into clear, accurate text
Requirements
What you’ll need- Academic degree in any of the biomedical sciences (eg, life sciences, pharmacy, medicine)
- A graduate degree will be considered as advantage
- At least 5 years (5-8 years, preferable) of experience in medical writing in the pharmaceutical domain
- Proven experience in authoring regulatory documents (clinical study protocols and reports, informed consent forms, Investigator brochures, etc.) in the pharmaceutical industry
- Working knowledge of relevant regulatory guidance documents including ICH E3, ICH E6, ICH M4E
- Experience in writing summary CTD documents would be considered a strong asset
- Strong organizational, interpersonal and communication skills
- Strong knowledge of MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems
- Ability to manage multiple projects
- A Medical Writing Certification will be considered a strong asset
Benefits
Comp & perks- supportive culture
- strong emphasis on employee training and well-being
ATS Keywords
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Hard Skills & Tools
medical writingregulatory documentsclinical study protocolsclinical summary CTD documentsinformed consent formsinvestigator brochuresstatistical analysis plansTFLs
Soft Skills
organizational skillsinterpersonal skillscommunication skillsmentoringcollaborationprocess improvementdocument strategy development
Certifications
Medical Writing Certification