Description
You will provide hands-on medical writing expertise and data review for preclinical and clinical stage projects.
Responsibilities
- Develop and manage clinical documents to ensure accuracy, consistency, and regulatory compliance.
- Manage writing assignments to meet strict project timelines.
- Lead technical discussions and address audit findings as a subject matter expert.
- Collaborate with internal teams across various project stages.
Required Skills
- Advanced scientific degree.
- Minimum of 4 years in pharmaceutical regulatory writing.
- Deep understanding of drug development and clinical data.
- Experience with GCP, Clinical Trials, Regulatory Requirements, and NDA.
- Proficiency in MS Office and publishing software.
- Strong organizational and communication skills.
- Ability to manage cross-departmental relationships.