Requires Medical Writer ( Immediate Joiner ) - Life Sciences

Company Name : Samahita Research Solutions

Designation: Medical Writer

Education: Life Science

Years of Experience: 2 Years of

Experience in Medical Writing Looking for immediate Joiner

Job Description:

Jr. Medical Writer

• Provide strategic medical and scientific leadership for clinical trials conducted by the organization.

• Ensure compliance with regulatory, ethical, and medical standards in all clinical research activities.

• Oversee the design, planning, and execution of clinical trials, including protocol development and risk assessment.

• Review and approve clinical trial protocols, investigator brochures, informed consent documents, and other study-related materials.

• Serve as a key medical expert in client interactions, proposals, and

  presentations.

• Support regulatory submissions and communications with health authorities, including providing medical expertise for INDS, NDAs, and other filings.

• Collaborate with cross-functional teams, including clinical operations, data management, regulatory affairs, and quality assurance, to achieve project milestones.

• Monitor ongoing clinical trials for safety, efficacy, and adherence to study protocols.

• Address and resolve medical queries, safety concerns, and protocol deviations during clinical trials.

• Train and mentor clinical research teams, ensuring high standards of medical knowledge and practice.

• Stay updated with industry trends, guidelines, and advancements in clinical research and therapeutic areas.

• Represent the organization at scientific and medical conferences, client

meetings, and regulatory audits.

• Contribute to business development by identifying new opportunities, assisting in proposal development, and supporting client relationships.

• Ensure patient safety and ethical conduct throughtout the clinical trial lifecycle.

How to Apply :

Eligible candidates Kindly drop your resume to career@samahitha.com