Protocol / Medical Writer - Late Phase - Brillex Clinical Research

Role & responsibilities

1. Responsible for clinical trial medical science related activities like preparation of protocol, Informed consent form, CRF, other study related documents and SOPs in line with ICH GCP, Indian and global regulatory.

2. Conduct relevant literature search for required for protocol and manuscript writing.

3. Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines.

4. Ensure to follow all clinical and regulatory guidelines, processes and systems for medical science activities and ensure compliance to internal medical writing SOPs for Clinical trial.

5. Compiles, writes and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision.

6. To follow the designed process to write, review protocol for trials and work closely with operation team to ensure high quality operationally feasible protocol for clinical trial.

7. Prepare and review SOPs specific for medical writing for clinical trial.

8. Work closely with different stakeholders for review of study documents (such as statistical analysis plan etc) and data review activities.

9. Any other responsibilities as assigned by the HOD/Management

Preferred candidate profile

Candidate must have exposure in Late Phase / Clinical Trial protocol writting.

Experienced in Medical Writing with expertise in overseeing early and late phase clinical studies. Responsible for working with cross-functional teams involved in protocol development. Ensures timely and high-quality development, review and finalization of study protocols, informed consent forms and other documents in alignment with ICH-GCP guidelines, applicable national and international guidelines sponsor/regulatory requirements. Ensuring collaboration with multiple stakeholders across Clinical Operations, Biostatistics, Bioanalytical, PK and other departments to maintain scientific accuracy, operational efficiency, and regulatory compliance. Additionally, involves managing communication with ethics committees and regulatory authorities (e.g., CDSCO), monitoring submission timelines, addressing queries and ensuring up-to-date knowledge of evolving global regulatory guidelines.