Pharma IT Medical Writing Consultant
3 days ago
At Pharma IT, we are seeking a highly skilled Senior/Principal Medical Writer Consultant to join our Regulatory Affairs & Medical Writing Team.
This role will involve working as a consultant to support our clients in the Pharma, Biotech, and Medical Device industries. The ideal candidate will have experience from different biotech and pharma companies working with clinical development in various indications.
Main Responsibilities:
- Write and review clinical documents for regulatory submissions in the EU and US, including Module 2.5, 2.7, 2.4, 2.6, integrated summaries of efficacy/safety, clinical trial protocols and reports, Paediatric Investigational plans, Orphan Drug Designation applications, Investigator's Brochure, meeting requests and briefing documents, and other related documents.
- Participate in answering questions from Health Authorities worldwide.
- Write and review scientific publications and scientific presentations.
- Collaborate with cross-functional teams, including external stakeholders, to ensure project goals, deliverables, and requirements.
- Foster effective communication and collaboration among project team members, ensuring clarity of roles and responsibilities.
- Ensure compliance with regulatory requirements and industry standards throughout the project lifecycle.
- Evaluate project outcomes and provide recommendations for process improvements and best practices.
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