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Senior Medical Writer

Primary Location: India, Remote Job ID R0000046124 Category Medical Writing Date Posted 10/06/2026

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- Success profile
- About this role
- Potential career path
- Employee insights
- Our team
- Why Medical Writers work at Parexel
- Learn about our culture

Overview As a Medical Writer at Parexel, your strong scientific knowledge, writing skills, and patient focus effectively communicate complex scientific data to various stakeholders, including regulatory agencies, medical professionals, and the general public. You must be able to collaborate within cross-functional teams to achieve the development of a wide range of clinical research documents, such as model informed consent forms, clinical study reports, pharmacovigilance documents, and more. We foster a culture of inclusivity, collaboration, and support that empowers our employees to make a meaningful impact on people's lives.

We offer continuous learning from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team. Your development and promotion are based on global standards and your personal development plan.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

- Adaptable
- Communicator
- Consistent
- Deadline-oriented
- Detail-oriented
- Insightful

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About This Role

About Parexel

Parexel is a leading global clinical research organization (CRO) committed to advancing clinical research and improving patient outcomes worldwide. We partner with biopharmaceutical companies, medical device manufacturers, and academic institutions to conduct high-quality clinical trials and deliver innovative solutions across all phases of development. Our multidisciplinary team of experts is dedicated to ensuring regulatory compliance, scientific excellence, and operational efficiency in every project we undertake.

About The Role

We are seeking an experienced Senior Medical Writer with specialized expertise in clinical trial disclosure and transparency to join our growing team. In this strategic role, you will lead the preparation, review, and delivery of clinical trial transparency submissions while providing regulatory guidance and mentoring junior team members. You will work with global clients to navigate complex disclosure requirements and ensure compliance with evolving regulations.

This position offers the opportunity to make a meaningful impact on clinical research transparency and patient access to trial information.

Key Responsibilities

- Independently lead the preparation, review, and delivery of clinical trial transparency submissions, including protocol registrations, results postings, plain language summaries (PLS), lay protocol synopses (LPS), redaction/anonymization packages, anonymization reports, and CCI justification tables
- Advanced clinical and regulatory document authoring and review expertise, including Study Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Forms (ICFs), Clinical Overviews, Clinical Summaries, and Safety Reports




- Provide strategic and regulatory guidance on clinical trial disclosure requirements to clients and internal teams
- Lead client interactions and provide disclosure-related consultation on complex regulatory matters
- Independently manage complex disclosure projects from initiation through delivery
- Provide regulatory interpretation and strategic recommendations to support client decision-making
- Contribute to process improvements and best practice development within the disclosure team
- Mentor and train junior team members on disclosure requirements, document development, and regulatory compliance
- Ensure all submissions meet quality standards and regulatory requirements across multiple jurisdictions

Required Qualifications

- Experience in medical writing field with demonstrated expertise in clinical trial disclosure and transparency
- Thorough understanding of global clinical trial disclosure and transparency regulations, including ClinicalTrials.gov, EudraCT, EU-CTR/CTIS, EMA Policy 0070, and Health Canada requirements
- Extensive experience with protocol registration, results reporting, registry maintenance, and disclosure compliance strategies
- Robust understanding of health literacy principles and demonstrated ability to develop clear, patient-facing disclosure documents
- Thorough knowledge of data protection regulations and their application to anonymization and redaction activities
- Advanced expertise in identifying and justifying PPD (Personally Identifiable Data) and CCI (Confidential Commercial Information) redactions
- Excellent written and verbal communication skills with ability to explain complex regulatory concepts clearly
- Bachelor's degree in life sciences, health sciences, or related field (or equivalent professional experience)

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply! We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

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Potential Career Path Parexel offers career paths for Medical Writers to progress in their technical position or managerial position, as well as options to move to other areas of the business.
- Associate Medical Writer
- Medical Writer I
- Medical Writer II
- Senior Medical Writer
- Subject Matter Expert

People Management

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Employee Insights

What excites you about being a Medical Writer at Parexel?

Mati Kargren | Medical Writer II

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How were you supported in getting settled at Parexel?

Joanna Gore | Senior Medical Writer

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Why did you join Parexel?

Urvashi Thakur | Medical Writer I

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TEAM IMPRESSIONS

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WHY MEDICAL WRITERS WORK AT PAREXEL

Patient-focused in everything we do

We create medical documents to improve the patient experience and make clinical trials more inclusive and patient-focused.

Supportive and inclusive environment

We foster a culture of inclusion and respect at all levels.



Our leaders lead by example and have a service mindset.

Career growth and development

We offer growth and encouragement through continuous training, stretch assignments, and learning opportunities.

Mentorship

We pair experienced Medical Writers with junior team members, providing opportunities for professional development and skill-building.

Flexible work

We focus on outputs and results, not where and when you work. Many of our Medical Writers work from home and meet at conferences or other gatherings.

Diverse projects

We continuously learn from a broad exposure from diverse clients working on different therapeutic areas at all clinical trial stages

Culture of excellence

We recognize the importance of first-time quality and on-time projects to bring treatments to patients faster.

Global exposure

One of the largest Medical Writing teams in the industry, 180+ colleagues at various levels, spanning 4 continents.

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Learn About Our Culture

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- Meet Julia: CVP, Head of Medical Writing and GMBA Ireland

Julia provides leadership insights, inspiration and advice from her 20+ years at Parexel.

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- Meet Yogeeta: Senior Document Quality Reviewer

Yogeeta talks about returning to work after a 3-year career break, and the support she received from her manager at Parexel India.

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- Re-excel at Parexel: A Return-to-Work Program for Professionals

Parexel's Re-Excel program is designed to help professionals restart their careers after a break, providing structured support, skill-building opportunities, and a welcoming community.

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- Meet Muskaan Oberoi, a Patient Safety Associate II at Parexel

Muskaan brings dedication, teamwork, and a passion for innovation to her role. Discover her journey, daily impact, and what keeps her motivated to grow, With Heart®.

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- Medical Writing Careers Webinar Replay

Our expert medical writers share their extensive industry experience. Whether you're a seasoned medical writer or just starting, this webinar caters to all skill levels, offering valuable insight into the life of a Medical Writer and what it is like to work at Parexel.

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- Meet Dorothy: Senior Document Quality Reviewer

Dorothy shares her story about returning to work after a career break, and how she arrived at Parexel, having previously worked for another CRO. Dorothy even draws comparisons between Parexel and Hogwarts. Dorothy re-excelled at Parexel!

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- Medical Writing at Parexel

Join a global team of 700+ medical writers transforming complex scientific data into clear communications that advance therapies and improve patient care.

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- Meet Sanjay: India Country Head & Head CTS&L;

Sanjay discusses his dual role, Parexel’s strong collaborative and cohesive working environment, and how our patient-centric culture makes him feel connected.

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- Benefits & Support

At Parexel, we prioritize putting people first, allowing you to achieve your best work. Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture.

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- Emerging Talent Opportunities

Begin your career journey at Parexel with our emerging talent programs or our internships, placements and entry-level clinical roles. Advance science by keeping the patients in mind.

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- Inclusion at Parexel

Learn how Parexel celebrates the differences our workforce and patients bring and ensures an inclusive environment.

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📌 Senior Medical Writer (India)
🏢 ATLAS MEDICAL SERVICES LTD. STI.
📍 India