Senior Medical Writer – Clinical Research
Job ID: R-01332283
Job Type: Full-Time
Category: Clinical Research / Medical Writing
Work Mode: Fully Remote
Location: India
Job Overview
A leading global Contract Research Organization (CRO), part of the PPD® Clinical Research portfolio, is seeking an experienced Senior Medical Writer to support global clinical development programs. This role is ideal for skilled medical writing professionals with strong scientific expertise and hands-on experience in regulatory and clinical documentation.
As a Senior Medical Writer, you will deliver high-quality medical and scientific documents from planning through final submission, collaborate closely with internal and external stakeholders, and contribute to operational excellence across global clinical research projects.
Key Responsibilities
Plan, develop, write, and deliver high-quality medical and scientific documents for internal and external clients
Serve as primary author for routine regulatory documents, including clinical study reports (CSRs) and clinical study protocols
Summarize and interpret clinical data from clinical trials and related studies
Contribute to the development of complex clinical and regulatory documents such as Investigator’s Brochures (IBs), Investigational New Drug applications (INDs), and Marketing Authorization Applications (MAAs)
Review routine documents prepared by junior writers to ensure quality, accuracy, and regulatory compliance
Provide guidance, training, and mentorship to junior medical writers and program managers as required
Ensure compliance with internal quality standards, SOPs, and global regulatory guidelines
Develop and implement best practices and client-specific processes to optimize document quality and delivery
Support program management activities, including timelines, forecasting, and identification of out-of-scope work
Represent the medical writing function at project launch meetings, review meetings, and cross-functional team discussions
Education & Experience Requirements
Bachelor’s degree in Life Sciences or a related scientific discipline
Advanced degree (Master’s or PhD) preferred
Minimum 5+ years of relevant medical writing experience in the pharmaceutical or CRO industry
Proven experience authoring clinical and regulatory documents for global submissions
Professional certifications in medical writing (AMWA, EMWA, RAC) are an advantage
Equivalent combinations of education, training, and directly related experience may be considered
Required Skills & Competencies
Excellent medical and scientific writing skills with strong attention to grammar, clarity, and accuracy
Strong data interpretation, editorial, and proofreading capabilities
Solid understanding of global, regional, and country-specific document development guidelines
In-depth expertise in one or more specialty areas, such as clinical development, regulatory submissions, or therapeutic communications
Strong project management, organizational, and time management skills
Excellent verbal, written, and presentation skills
Strong interpersonal, problem-solving, and negotiation abilities
Sound judgment and independent decision-making capability
Proficiency with document management systems, client templates, and standard office applications (e.g., MS Word, Excel, Outlook)
Why Join This Organization
Work on global clinical research programs across multiple therapeutic areas
Collaborate with international cross-functional teams and clients
Enhance expertise in regulatory and clinical medical writing
Access continuous learning, professional development, and career progression opportunities
Contribute to the development of life-changing therapies for patients worldwide
About PPD® Clinical Research / Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in serving science, enabling customers to make the world healthier, cleaner, and safer. Through its PPD® Clinical Research Services, the organization supports clinical development programs across 100+ countries, delivering innovative and patient-focused research solutions.
Thermo Fisher Scientific is an equal opportunity employer and values diversity, equity, and inclusion.
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