A leading organization in clinical research and development located in Mira Road, Mumbai, is seeking a Medical Writer/Senior Medical Writer to join their Clinical Department. The company focuses on maintaining high standards of quality and compliance in clinical documentation and regulatory submissions.
Designation: Medical Writer/Senior Medical Writer
This position requires experienced individuals with a background in pharmaceutical sciences and a strong grasp of clinical and regulatory documentation processes.
Key Responsibilities
- Protocol Preparation: Draft and finalize study protocols, informed consent forms (ICF), and other regulatory documents.
- Study Design and Review: Develop and critically review study protocols to ensure alignment with Good Clinical Practice (GCP) and relevant national and international regulatory guidelines.
- Regulatory Submissions: Oversee the preparation and timely submission of the final versions of protocols.
- Clinical Study Reports: Compile and submit comprehensive clinical study reports post-study completion.
- SOP Review: Regularly review clinical standard operating procedures (SOPs) to ensure compliance and relevance.
- Documentation and Change Control: Raise change control documentation related to clinical SOPs, instruments, and equipment.
- Audit Response: Provide responses with corrective and preventive action plans (CAPA) to quality assurance, sponsors, and regulatory audit observations.
- Additional Tasks: Perform additional duties as assigned by the Head of Department, Investigator, or Manager.
Desired Skills
- Strong understanding of clinical research, GCP, and applicable regulatory guidelines.
- Excellent writing, analytical, and organizational skills.
- Ability to handle multiple projects with a keen eye for detail.
- Proficiency in handling change control documentation and CAPA responses.
Location
- Job Location: Mira Road, Mumbai, Maharashtra, India.
Interested candidates drop resume in hr@biosrl.com
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