Senior Medical Writer

Role Overview

• 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

• 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

• supportive culture
• strong emphasis on employee training and well-being