ClinChoice

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Medical Writer Consultant for 12 months Contract with possibility of extension to join one of our clients.

We are seeking a detail-oriented and skilled Medical Writer to join our team with oncology experience. The ideal candidate will have a strong understanding of medical and scientific principles, exceptional writing skills, and the ability to convey complex information clearly and concisely. As a medical writer, you will play a crucial role in preparing high-quality documentation for clinical research, regulatory submissions, and publications.

• Key Responsibilities:
• Support preparation of regulatory submissions (INDs, NDAs, etc) with focus on oncology trials.
• Develop, write, and edit various documents, not limited to clinical study protocols, clinical study reports, clinical modules, manuscripts.
• Collaborate/interact closely with clients, internal cross functional teams, to gather information and ensure accuracy of content.
• Review and interpret clinical data and research findings to produce clear and concise documents fit for audience, including regulatory authorities.
• Ensure that all writing aligns with company standards, guidelines, and regulatory requirements.
• Maintain and manage timelines for document delivery while ensuring high-quality output.
• Conduct literature searches and maintain knowledge of current scientific and regulatory trends relevant to medical writing.
• Participate in internal meetings to discuss study progress and regulatory requirements.

Preferred Skills:

• Strong understanding of various reports writing and regulatory requirements (e.g., FDA, EMA) focused on oncology therapeutic area with knowledge of cancer biology, clinical trial endpoints, oncology trial designs
• Understanding of statistical analysis and presentation of complex clinical data.
• Excellent writing, editing, and communication skills with keen attention to detail.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with medical writing software (e.g., EndNote).
• Ability to work independently and collaboratively.
• Strong organizational and project management skills, with the ability to manage multiple projects simultaneously.

Qualification and experience:

• Advanced degree in medical science or life sciences in alignment with project / business team requirements

5 to 8 years of relevant experience in oncology clinical research.