Senior Medical Writer – Remote, India
Location: Remote, India
Job Type: Full-Time
Job ID: R-01332283
Category: Clinical Research / Medical Writing / Pharmaceutical
About the Role
We are seeking a Senior Medical Writer to join our global clinical research team. This remote role involves producing high-quality medical and scientific documents, supporting clinical trials and regulatory submissions. The Senior Medical Writer will act as a primary author for complex documents, provide guidance to junior writers, and support program management activities, ensuring compliance with regulatory and client-specific standards.
Key Responsibilities
Author, review, and edit clinical study reports (CSRs), study protocols, investigator brochures (IBs), INDs, and marketing authorization applications (MAAs).
Serve as primary author for routine and complex medical and scientific documents, summarizing clinical study data effectively.
Review and provide feedback on documents prepared by junior writers, ensuring quality and compliance.
Mentor and provide guidance to junior writers and program managers on document preparation, regulatory requirements, software tools, and therapeutic area knowledge.
Ensure adherence to quality processes, SOPs, and client-specific guidelines.
Support program management tasks, including developing timelines, budgets, forecasts, and managing contract modifications.
Represent the medical writing team in project launch meetings, review meetings, and cross-functional project discussions.
Contribute to process improvement initiatives and best practice development for medical writing standards.
Education & Experience Requirements
Bachelor’s degree in a scientific discipline; advanced degree preferred.
5+ years of relevant experience in medical writing, including clinical and regulatory document preparation.
Experience in the pharmaceutical or CRO industry preferred.
Professional medical writing qualifications (AMWA, EMWA, RAC) are advantageous.
Equivalent combinations of education, training, and experience may also be considered.
Skills & Competencies
Strong expertise in data interpretation, scientific writing, editorial, and proofreading skills.
In-depth knowledge of global, regional, and national regulatory guidelines for document development.
Specialty area expertise in preclinical, clinical, regulatory submissions, or medical communications.
Excellent project management, problem-solving, negotiation, and decision-making skills.
Proficient in document management systems, Microsoft Office applications, and client templates.
Exceptional oral and written communication with strong presentation capabilities.
Ability to mentor and guide junior writers and manage program-level documentation activities.
Career Growth & Opportunities
As a Senior Medical Writer, you will gain:
Global Exposure: Work on international clinical studies and regulatory submissions across therapeutic areas.
Leadership Opportunities: Mentor junior writers and contribute to program management.
Professional Advancement: Pathways to Principal Medical Writer, Medical Writing Lead, or Therapeutic Area Expert roles.
Cutting-Edge Experience: Participate in high-visibility projects, implementing best practices in medical writing and regulatory documentation.
Why Join
Join a leading global CRO and contribute to the development of life-changing therapies worldwide. You will work in a collaborative, innovative, and growth-oriented environment, where your medical writing expertise directly impacts clinical and regulatory outcomes.
Equal Opportunity Employer: We are committed to diversity, inclusion, and equitable career opportunities for minorities, females, veterans, and individuals with disabilities.
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