Text copied to clipboard!
Title
Text copied to clipboard!Clinical Writer
Description
Text copied to clipboard!
We are looking for a Clinical Writer to join our team. The successful candidate will be responsible for creating and editing clinical documents for submission to regulatory authorities, including but not limited to, clinical study reports, investigator brochures, and clinical summaries. The Clinical Writer will work closely with other clinical, regulatory, and product development teams to ensure the scientific integrity of all documents. The ideal candidate will have a strong background in medical writing and a deep understanding of clinical research. They will be detail-oriented, able to manage multiple projects simultaneously, and have excellent written and verbal communication skills. The Clinical Writer will also be responsible for ensuring all documents are in compliance with regulatory guidelines and standards.
Responsibilities
Text copied to clipboard!- Creating and editing clinical documents for regulatory submissions.
- Working closely with clinical, regulatory, and product development teams.
- Ensuring the scientific integrity of all documents.
- Managing multiple projects simultaneously.
- Ensuring all documents are in compliance with regulatory guidelines and standards.
- Reviewing and editing documents written by other team members.
- Conducting literature searches and reviews as necessary for document preparation.
- Collaborating with statisticians and data management teams to understand and present complex data.
- Maintaining current knowledge of regulatory guidelines and standards.
- Participating in project team meetings and providing writing and editorial support as needed.
Requirements
Text copied to clipboard!- Bachelor's degree in a scientific or medical field.
- Minimum of 3 years of medical writing experience.
- Strong knowledge of clinical research and regulatory guidelines.
- Excellent written and verbal communication skills.
- Ability to manage multiple projects simultaneously.
- Detail-oriented with strong organizational skills.
- Proficiency in Microsoft Office and Adobe Acrobat.
- Experience with statistical analysis and presentation of complex data.
- Ability to work independently and as part of a team.
- Strong problem-solving skills.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with clinical research?
- How do you manage multiple projects simultaneously?
- Can you provide an example of a complex document you have written?
- How do you ensure the scientific integrity of your documents?
- Can you describe your experience with regulatory guidelines and standards?