Role & responsibilities

- Preparation and Finalization 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.
- Draft, review, and finalize clinical study synopses/protocol summaries by reviewing applicable guidance documents, scientific literature, and study-drug information, ensuring alignment of study objectives, endpoints, methodology, and regulatory requirements while collaborating with cross-functional stakeholders.
- Seeking inputs from and coordinating with Project-coordinators, Principal Investigator/clinical Investigator and Clinical Team, Bio-analytical Team, Clinical Laboratory Team, Quality Assurance and Statisticians for preparation of CSRs and study Protocols of expected quality in a timely manner.
- Preparation and Finalization of English language Informed Consent Forms for Clinical Studies with input from the Principal Investigator and Research Associate/Sub-Investigator and Quality Assurance personnel.
- Preparation of Amendments and/or addendums and/or Errata and Version History to Clinical study protocols and CSRs in line with in-house SOP, as per sponsors and regulatory requirements.
- Receive and review feasibility requests from the respective stakeholder, coordinate with internal Clinical, Analytical, and Regulatory teams to assess study conduct feasibility, and ensure timely collection of comprehensive feasibility inputs.
- Review pharmacokinetic data, including concentration-time profiles, and PK parameters to ensure accuracy,



completeness, and scientific validity, collaborate with Clinical, and Biostatisticians, teams to interpret findings, address data queries, and support the preparation of study synopses, reports, and regulatory documentation.
- Consolidate, evaluate, and communicate feasibility outcomes, including operational capabilities, regulatory considerations, timelines, and potential risks, to the respective stakeholder to support proposal development and informed decision-making.
- Preparation of responses to sponsor and regulatory queries pertaining to clinical study reports in conjunction with the investigator.
- Preparation, revision and updating of Standard Operating Procedures pertaining to Medical Writing Department-BA/BE. Imparting training to staff on relevant SOPs.
- Imparting training to current recruits and cross-domain training of employees in matters related to preparation of study protocols and participating in Departmental Training Programmes.
- Allocation of tasks to team members and ensure the allocated tasks are completed within the team.
- 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

- 5 to 8 years of experience in Medical Writing within the CRO industry.
- Experienced in performing statistical review of clinical documents.
- The candidate should be willing to relocate to Manipal(Udupi-Karnataka).

📌 Medical Writer (BA/BE Services) (Manipal)
🏢 Navitas Life Sciences
📍 Manipal