Job Title: Senior Medical Writer
Job ID: R-01332283
Location: Remote – India
Job Type: Full-Time
Category: Clinical Research / Medical Writing
Work Mode: Fully Remote
Experience Required: Minimum 5+ years in Medical Writing
About the Organization
Our Clinical Research Services team operates at the forefront of global drug development, supporting the delivery of innovative therapies that address some of the world’s most complex health challenges. As part of the PPD clinical research portfolio within a leading global Contract Research Organization (CRO), we combine scientific excellence with operational expertise to accelerate clinical development programs worldwide.
Role Overview
The Senior Medical Writer is responsible for delivering high-quality medical and scientific documentation across the clinical development lifecycle. This role serves as a primary author for clinical study documents and collaborates closely with cross-functional internal and external stakeholders to ensure clarity, compliance, and timely delivery.
The position requires strong expertise in clinical research documentation, regulatory guidelines, and therapeutic area knowledge, along with the ability to mentor junior writers and contribute to operational excellence.
Key Responsibilities
Serve as primary author for clinical study reports, study protocols, and other routine clinical documents.
Research, write, and edit complex clinical and regulatory documents, including Investigator’s Brochures (IBs), INDs, and MAAs, as required.
Summarize and interpret clinical data accurately for regulatory and scientific audiences.
Review documents prepared by junior medical writers and provide constructive feedback to ensure quality and compliance.
Support training and mentorship of junior writers and program managers on document development processes and regulatory requirements.
Ensure all assigned documents comply with internal quality standards, client requirements, and global regulatory guidelines.
Contribute to the development and implementation of best practices, templates, and document development methodologies.
Assist in program management activities, including timeline development, scope management, and resolution of out-of-scope activities.
Participate in project launch meetings, document review meetings, and cross-functional project team discussions.
Experience Requirements
Minimum 5+ years of relevant experience in medical writing within a pharmaceutical company, CRO, or clinical research environment.
Proven experience authoring and reviewing clinical study reports, protocols, and regulatory documents.
Prior exposure to global regulatory submissions and interactions is strongly preferred.
Educational Qualifications
Bachelor’s degree in a scientific discipline or equivalent qualification required.
Advanced degree (Master’s or PhD) in Life Sciences, Pharmacy, or related field preferred.
Professional certifications such as AMWA, EMWA, or RAC are advantageous.
Key Skills & Competencies
Excellent medical and scientific writing, editing, and proofreading skills.
Strong ability to interpret and present complex clinical data clearly and accurately.
Solid understanding of global document development guidelines and regulatory standards.
Effective project management, organizational, and time management skills.
Strong interpersonal, negotiation, and problem-solving abilities.
Excellent written and verbal communication skills with strong presentation capability.
Proficiency in document management systems and common office tools (MS Word, Excel, Outlook).
Ability to work independently in a remote, fast-paced global environment.
Why Join Us
Fully remote role with a globally recognized CRO.
Opportunity to work on diverse international clinical development programs.
Collaborative, science-driven environment with strong career growth potential.
Exposure to global regulatory strategies and high-impact clinical research.
Apply through ThePharmaDaily.com to advance your medical writing career in a global clinical research environment.
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