Senior Medical Writer – Clinical Research (Fully Remote)
Location: Remote, India
Employment Type: Full-Time
Work Model: Fully Remote
Industry: Clinical Research / CRO / Pharmaceutical
A leading global contract research organization, Thermo Fisher Scientific (PPD Clinical Research portfolio), is seeking an experienced Senior Medical Writer to support high-quality scientific documentation across global clinical development programs. This role is ideal for professionals with strong regulatory writing expertise and therapeutic area knowledge within the pharmaceutical or CRO industry.
Job Overview
The Senior Medical Writer is responsible for developing, reviewing, and delivering scientifically accurate and regulatory-compliant clinical and medical documents. Acting as a primary author, the individual will support clinical trial documentation, regulatory submissions, and cross-functional collaboration to ensure timely and high-quality project execution.
This position requires advanced data interpretation skills, deep understanding of global regulatory guidelines, and the ability to manage multiple complex writing projects within strict timelines.
Key Responsibilities
Author and contribute to Clinical Study Reports (CSRs), study protocols, and data summaries
Develop and edit complex regulatory documents including Investigator’s Brochures (IBs), INDs, and MAAs
Ensure compliance with global, regional, and local regulatory guidelines
Review documents prepared by junior medical writers and provide mentorship
Collaborate with internal stakeholders, sponsors, and cross-functional teams
Participate in project launch and review meetings
Support program management activities including timelines, forecasts, and scope assessments
Identify and manage out-of-scope activities
Contribute to best practice development and process improvements
Ensure adherence to document quality standards and client-specific templates
Experience Level: Senior Level
Experience Required:
Minimum 5+ years of relevant medical writing experience
Prior experience in pharmaceutical, biotechnology, or CRO industry preferred
Proven experience authoring clinical and regulatory submission documents
Experience mentoring junior writers is advantageous
Educational Qualification
Bachelor’s degree in Life Sciences or a related scientific discipline required
Advanced degree (Master’s/PhD/MD) preferred
Certifications such as AMWA, EMWA, or RAC are advantageous
Core Competencies
Advanced medical and scientific writing skills
Strong data interpretation and analytical capabilities
In-depth knowledge of global regulatory submission requirements
Excellent project management and organizational skills
Strong interpersonal and stakeholder management skills
Proficiency in document management systems and MS Office tools (Word, Excel, Outlook)
Ability to manage multiple deliverables in a remote working environment
About the Organization
Thermo Fisher Scientific, through its PPD clinical research portfolio, delivers clinical development and laboratory services globally. The organization partners with pharmaceutical and biotechnology companies to accelerate drug development and bring innovative therapies to patients worldwide.
Why Apply Through ThePharmaDaily.com
Access to global remote clinical research opportunities
Increased visibility for senior regulatory writing roles
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