Parexel Hiring Now | Remote Senior Medical Writer Job | Pharma Graduates Apply
The Senior Medical Writer Job at Parexel offers a remote opportunity in India for experienced professionals in clinical and regulatory writing. As part of Parexel Careers, this role focuses on authoring, reviewing, and managing clinical and regulatory documents that support global drug development programs. Candidates with a strong background in medical writing, regulatory documentation, and clinical research processes are encouraged to explore this position.
About the Company
Parexel fosters a culture of inclusivity, collaboration, and support that empowers employees to make a meaningful impact on people’s lives. The organization offers continuous learning through mentoring, job shadowing, job rotation, stretch assignments, and leadership opportunities. Employee development and promotion are based on global standards and individual personal development plans.
Job Details
| Company | Parexel |
| Job Title | Senior Medical Writer |
| Location | India, Remote |
Job Description
- As a Medical Writer at Parexel, you will apply scientific expertise and writing skills to communicate complex clinical and scientific data to regulatory agencies, medical professionals, and the general public.
- The role involves developing and managing a wide range of clinical research documents, including model-informed consent forms, clinical study reports, pharmacovigilance documents, and regulatory submissions.
- You will collaborate with cross-functional teams, review statistical outputs, ensure regulatory compliance with ICH-GCP, FDA, and EMA guidelines, and maintain document quality, accuracy, and publishing readiness across global drug development programs.
Key Responsibilities
- Author and review 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.
- Ensure compliance with ICH-GCP, FDA, EMA, client requirements, SOPs, and regulatory guidelines.
- Coordinate cross-functional reviews and manage document timelines.
- Serve as the Medical Writing representative on project teams.
- Review statistical outputs for accurate presentation and interpretation of clinical data.
- Perform quality reviews to ensure consistency, accuracy, and publishing readiness.
- Mentor junior writers and contribute to process improvement and training initiatives.
Eligibility Criteria
- Education: Bachelor’s, Master’s, PharmD, MD, PhD, or equivalent degree in Life Sciences, Pharmacy, Medicine, or a related field.
- Experience: Experience in Medical Writing, preferably within a CRO, pharmaceutical, or biotechnology environment.
Required Skills
- Strong experience authoring Protocols, CSRs, Investigator Brochures, and CTD documents.
- Solid understanding of clinical research and drug development processes.
- Knowledge of ICH-GCP guidelines.
- Excellent scientific writing and editing skills.
- Strong communication and stakeholder management abilities.
- Proficiency in Microsoft Word and Excel.
- Experience with document management systems and collaborative authoring tools.
- Ability to manage multiple projects and meet deadlines.
Success Profile
- Adaptable
- Communicator
- Consistent
- Deadline-oriented
- Detail-oriented
- Insightful
Why Join this Role?
Parexel supports employee growth through mentoring, job shadowing, job rotation, stretch assignments, and leadership opportunities. The organization emphasizes inclusivity, collaboration, and continuous learning. Career development and promotion are aligned with global standards and personalized development plans, allowing professionals in this Senior Medical Writer Job to contribute meaningfully to global drug development while advancing their expertise.
Disclaimer: Pharmanika is a career information portal and is not the recruiter for this position. All details are sourced from the official notification. Candidates should verify eligibility and deadlines on the official website before applying.
