The Medical Writer will provide high-quality regulatory writing services for both internal and external clients. The role involves developing regulatory documents for peri-/post-approval clinical studies, offering technical advice on regulations and industry best practices, and managing medical writing projects with efficiency and operational excellence.
Key Responsibilities:
- Independently write and edit clinical study reports, study protocols, informed consent forms, and other peri-/post-approval regulatory documents.
- Manage all project aspects, including planning, organizing, and executing, without supervision.
- Collaborate with cross-functional teams such as QA, project management, clinical, data management, biostatistics, and regulatory teams.
- Represent the department in client-facing meetings, audits, and presentations.
- Identify project risks, out-of-scope activities, and propose solutions.
Required Qualifications:
- Education: Bachelor’s degree in a scientific discipline (Advanced degree preferred).
- Experience: 2-5 years in medical writing or equivalent combination of education and experience in pharmaceutical/CRO industries.
- Familiarity with global and regional regulatory guidelines.
- Additional qualifications in medical writing (e.g., AMWA, EMWA, BELS, RAC) are advantageous.
Skills & Competencies:
- Excellent written English with strong attention to detail.
- Strong computer and document management system skills (e.g., Excel, Outlook).
- Ability to manage and analyze complex data, numbers, and issues.
- Capable of effective project management, conflict resolution, and communication with internal/external stakeholders.
Work Environment:
- Fully remote
- Opportunity to work with a leading global CRO.
