Navitas Lifesciences looking to hire Assistant Manager/ Manager – Medical Writing || Apply Now
Manager – Medical Writing
Role & responsibilities
- Work Allocation regards to Protocols, Informed Consent Forms, Synopsis and Clinical study reports to Protocol and Clinical Study report writers.
- Verify and ensure that the reports are drafted as per ICH E3 and applicable regulatory guidelines.
- Drafting the responses to Sponsor and Regulatory queries in conjunction with Investigator and other applicable documents.
- Review of Clinical Study Protocols and Clinical Study Reports (BA/BE and Phase I) for various regulatory submissions.
- Preparation of Clinical study protocols and CSRs for Phase I and BA/BE studies in line with in-house SOP, Sponsors study objectives, regulatory requirements and ICH guidelines.
- Preparation of English language Informed Consent Forms for Clinical Studies with input from the Principal Investigator and Research Associate/Sub-Investigator, Compliance and Scientific Affairs personnel and Quality Assurance personnel.
- Review of Pharmacokinetic and Statistical data output generated for respective study.
- Preparation, revision and updating of Standard Operating Procedures pertaining to Medical Writing Department-BA/BE. Imparting training to staff on relevant SOPs.
- Preparation of appendices in eCTD format and/ or as per sponsors and regulatory requirements.
- Allocation of tasks to team members and ensure the allocated tasks are completed within the team.
Preferred candidate profile
- Knowledge in BA/BE clinical studies.
- Knowledge of ICH – GCP guidelines.
- Knowledge in Regulatory guidelines like CDSCO, USFDA, EMEA, WHO etc.
- Good oral and written communication skills.
Greetings from Ecron Acunova!
We are looking to hire Assistant Manager/Manager – Medical Writing for BA/BE Unit, Manipal.
Experience: 6 to 10 years
Job Location: Manipal-Karnataka (Office based)
Interested can share their CVs to –
[email protected]
Or
