Are you a skilled writer with a passion for clinical documents and regulatory affairs? We’re looking for a Narrative Writer to join our team in Mumbai or Pune. As a Narrative Writer, you’ll play a critical role in creating high-quality clinical documents, including protocols, clinical study reports, and regulatory documents.
✅About the Role
In this role, you’ll work closely with cross-functional teams to develop and review clinical documents, ensuring accuracy, clarity, and compliance with regulatory requirements. You’ll also be responsible for managing and maintaining document workflows, tracking changes, and ensuring the timely delivery of documents.
✅Key Responsibilities:
Write and review clinical documents, including protocols, clinical study reports, and regulatory documents
Ensure accuracy, clarity, and compliance with regulatory requirements
Collaborate with cross-functional teams to develop and review clinical documents
Manage and maintain document workflows, track changes, and ensure the timely delivery of documents
Utilise knowledge of regulatory guidelines, including ICH E3, E6, and E9
Experience with electronic document management systems, such as Veeva Vault, is a plus
✅Requirements:
3.5 to 12 years of experience in clinical writing or regulatory affairs
Strong knowledge of clinical research regulations and guidelines
Excellent writing and communication skills
Ability to work independently and manage multiple projects simultaneously
Strong attention to detail and ability to meet deadlines
✅Desirable Skills:
Experience with XEVMPD, OMS, IDMP, RIM, and Veeva Vault
Knowledge of eCTD, NEES, and Docubridge
Familiarity with regulatory publishing and document management systems
✅What We Offer:
Competitive salary and benefits package
Opportunities for professional growth and development
Collaborative and dynamic work environment
Flexible working hours and work-life balance
✅Why Choose This Role?
As a Narrative Writer, you’ll have the opportunity to work on complex and challenging projects, develop your skills, and contribute to the success of clinical trials. You’ll work closely with cross-functional teams, including clinical research, regulatory affairs, and medical writing.
✅Tips for Narrative Writers:
Develop strong writing and communication skills
Stay up-to-date with industry trends and regulatory requirements
Build relationships with cross-functional teams and stakeholders
Consider obtaining certifications, such as the Certified Medical Writer (CMW) certification
✅Narrative Writing Career Development
A career in narrative writing offers a wide range of opportunities for growth and development. As a Narrative Writer, you’ll have the chance to develop your skills in clinical writing, regulatory affairs, and document management.
✅Benefits of Working in Narrative Writing:
Opportunity to contribute to the development of clinical documents and regulatory submissions
Collaborative and dynamic work environment
Professional development and growth opportunities
Competitive salary and benefits package
📩 How to Apply
If you’re passionate about clinical writing and regulatory documentation, we’d love to hear from you!
📧 Send your resume to: sandeep.dalvi@myriadconsulting.co.in
📝 Subject Line: “Narrative Writer”