Regulatory Medical Writer (Clinical Trials)
Job Description
We are looking for an experienced Regulatory Medical Writer with strong expertise in drafting clinical study regulatory documents. The ideal candidate should have hands‑on experience in writing clinical study protocols and CSRs and be confident in handling client communication.
Key Responsibilities
• Draft and review Clinical Study Protocols
• Act as SPOC for clients for assigned projects
• Attend client meetings and coordinate with internal cross-functional teams
• Ensure timely delivery of high-quality regulatory documents
• Incorporate client feedback effectively and maintain version control
• Ensure compliance with applicable SOPs and regulatory guidelines
Support in annual SOP review and updates
Required Candidate Profile
• Degree in Life Sciences / Pharmacy / Medicine
• Proven experience in writing clinical study protocols (mandatory)
• Experience in CSR writing preferred
• Strong communication and stakeholder management skills
• High attention to detail and quality focus
• Ability to manage multiple projects and timelines independently
We are looking for an experienced Regulatory Medical Writer with strong expertise in drafting clinical study regulatory documents. The ideal candidate should have hands‑on experience in writing clinical study protocols and CSRs and be confident in handling client communication.
Key Responsibilities
• Draft and review Clinical Study Protocols
• Act as SPOC for clients for assigned projects
• Attend client meetings and coordinate with internal cross-functional teams
• Ensure timely delivery of high-quality regulatory documents
• Incorporate client feedback effectively and maintain version control
• Ensure compliance with applicable SOPs and regulatory guidelines
Support in annual SOP review and updates
Required Candidate Profile
• Degree in Life Sciences / Pharmacy / Medicine
• Proven experience in writing clinical study protocols (mandatory)
• Experience in CSR writing preferred
• Strong communication and stakeholder management skills
• High attention to detail and quality focus
• Ability to manage multiple projects and timelines independently