The Senior Medical Writer will be responsible for developing high-quality clinical study documents, including protocols, clinical study reports, and regulatory submission documents. They will collaborate with cross-functional teams to ensure adherence to guidelines and timelines. The ideal candidate will have a deep understanding of clinical research and regulatory requirements, with excellent writing, editing, and proofreading skills to translate complex scientific data into clear, concise, and accurate documents.
Key Responsibilities:
- Produce well-written, high-quality, and timely medical writing documents such as clinical study reports, protocols and amendments, Investigators Brochure (IB) and IB updates.
- Review medical writing documents in accordance with current SOPs, ensuring checklists and tracking documents are completed.
- Provide editorial support and proof-reading for documents produced by other departments or clients.
- Oversee medical writing projects and cross-functional projects using project management tools and processes.
- Manage the document review process, ensuring conflicting and ambiguous comments are clarified and addressed.
- Assist Principal Medical Writers and above with managing department budgets and financials.
- Contribute to business development by updating CVs, preparing and reviewing client proposals, and presenting at client and bid defense meetings.
- Line manage assigned personnel, actively contributing to their development and providing guidance and mentorship to less experienced medical writers.
- Conduct literature reviews and provide input on the development of scientific communication and messaging.
- Manage timelines and deliver documents within established deadlines.
Qualifications:
- Masters degree or higher in a life science or related field.
- Minimum 5 years of experience as a medical writer in the pharmaceutical, biotechnology, or CRO industry.
- Strong knowledge of clinical research, regulatory requirements, and industry guidelines (ICH-GCP).
- Excellent writing, editing, and proofreading skills, with the ability to communicate complex scientific information effectively.
- Experience in writing clinical study documents, such as protocols, clinical study reports, and regulatory submission documents.
- Detail-oriented with excellent organizational and time management skills.
- Ability to work independently and collaboratively in a team environment.
Benefits:
- Competitive salary (open to discussion based on experience).
- Flexible working hours.
- Generous leave policies (annual leave, sick leave, casual leave, and bank holidays).
- Medical insurance for self and immediate family.
- Gratuity.
- Accidental coverage.
- Various learning and development opportunities, including mentoring, coaching, e-learning, and job shadowing.
