Senior Medical Writer
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Location: Remote, India
Job Type: Full-Time | Fully Remote
Experience: Typically 5+ Years (Medical Writing / Clinical Research / CRO)
Qualification: Bachelor’s degree in a scientific discipline (Advanced degree preferred)
Salary Range: Not Specified
Job Overview
Thermo Fisher Scientific is seeking a Senior Medical Writer to deliver high-quality medical and scientific writing across clinical research documents.
The Senior Medical Writer will be responsible for planning, writing, reviewing, and finalizing clinical and regulatory documents including clinical study reports, study protocols, and investigator brochures. The role involves collaborating with internal and external stakeholders to ensure efficient communication, high-quality deliverables, and compliance with global regulatory standards.
This position also includes mentoring junior writers, contributing to best practices in medical writing, and supporting program management activities within clinical research projects.
Key Responsibilities
Medical Writing & Document Development
Develop and deliver high-quality clinical and scientific documents.
Serve as primary author for clinical study reports (CSR), study protocols, and related documents.
Contribute to writing and editing complex regulatory documents such as IBs, INDs, and MAAs.
Summarize and interpret clinical study data effectively.
Document Review & Quality Assurance
Review documents prepared by junior team members for accuracy and quality.
Ensure compliance with regulatory requirements and internal quality standards.
Apply best practices, methodologies, and client-specific processes in document development.
Collaboration & Stakeholder Management
Collaborate with internal teams and external clients to ensure efficient communication.
Participate in project meetings including launch, review, and team discussions.
Support operational excellence through effective cross-functional coordination.
Mentorship & Training
Provide training and mentorship to junior medical writers and program managers.
Guide team members on document preparation, regulatory requirements, and tools.
Support knowledge sharing and skill development within the team.
Program & Project Support
Assist in program management activities including timelines, budgets, and forecasts.
Identify and manage out-of-scope activities and propose solutions.
Support project execution and delivery within defined timelines.
Required Skills
Medical Writing Expertise
Strong experience in clinical and regulatory medical writing.
Ability to develop and review clinical study reports, protocols, and regulatory documents.
Proficiency in data interpretation and scientific communication.
Regulatory & Compliance Knowledge
Understanding of global and regional regulatory guidelines.
Knowledge of document development standards and submission requirements.
Familiarity with therapeutic areas and clinical research processes.
Communication & Collaboration
Excellent written and verbal communication skills.
Strong stakeholder management and interpersonal skills.
Ability to work effectively in cross-functional teams.
Project & Analytical Skills
Strong project management and organizational abilities.
Problem-solving and decision-making skills.
Ability to manage multiple priorities and timelines.
Technical Skills
Proficiency in document management systems and MS Office tools.
Familiarity with client templates and document development software.
Basic Qualifications
Bachelor’s degree in a scientific discipline or equivalent qualification
Minimum 5+ years of experience in medical writing
Experience in pharmaceutical or CRO environment
Preferred Competencies
Advanced degree in life sciences or related field
Certifications such as AMWA, EMWA, or RAC
Experience in regulatory submissions and complex document development
Key Competencies
Medical and scientific writing expertise
Clinical research documentation and regulatory compliance
Data interpretation and scientific communication
Cross-functional collaboration
Training and mentorship
Project and program support
About the Company
Thermo Fisher Scientific, through its PPD Clinical Research Services division, is a global leader in clinical research and drug development. The company supports pharmaceutical and biotechnology organizations in accelerating the development of life-changing therapies, operating across 100+ countries with a strong focus on innovation, quality, and patient outcomes.
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