Senior Medical Writer
Primary Location: India, Remote Job ID R0000043704 Category Medical Writing Date Posted 07/16/2026Overview
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
About This Role
Job Summary
We are looking for an experienced Senior Medical Writer to author, review, and manage clinical and regulatory documents supporting global drug development programs. The ideal candidate will have expertise in clinical research documentation, regulatory writing, project leadership, and stakeholder management, ensuring the delivery of high-quality documents that meet regulatory and client requirements.
Key Responsibilities
Author and review clinical and regulatory documents, including Study Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Forms (ICFs), Clinical Overviews, Clinical Summaries, and Safety Reports.
Conduct literature reviews and analyze scientific and clinical data to support document development.
Ensure documents comply with ICH-GCP, FDA, EMA, client requirements, SOPs, and regulatory guidelines.
Coordinate cross-functional reviews, manage document timelines, and incorporate stakeholder feedback.
Serve as the Medical Writing representative on project teams and act as a primary point of contact for assigned projects.
Review statistical outputs and ensure accurate presentation and interpretation of clinical data.
Perform quality reviews to ensure data consistency, accuracy, and publishing readiness.
Mentor junior writers and contribute to process improvement, training, and SOP development initiatives.
Required Qualifications
Bachelor's, Master's, PharmD, MD, PhD, or equivalent degree in Life Sciences, Pharmacy, Medicine, or a related field.
Must have experience in Medical Writing, preferably within a CRO, pharmaceutical, or biotechnology environment.
Strong experience authoring clinical and regulatory documents such as Protocols, CSRs, Investigator Brochures, and CTD documents.
Solid understanding of clinical research, drug development processes, and ICH-GCP guidelines.
Excellent scientific writing, editing, and communication skills.
Proficiency in Microsoft Word, Excel, document management systems, and collaborative authoring tools.
#LI-REMOTE
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 ExpertPeople Management
Employee Insights
TEAM IMPRESSIONS
WHY MEDICAL WRITERS WORK AT PAREXEL
