Work from home Medical Writer Opportunities at Parexel | Remote Jobs

Parexel Hiring Medical Writer I / II – Remote Pharmacovigilance & Regulatory Writing Jobs

Parexel is hiring Medical Writer I and Medical Writer II professionals for its Medical Sciences and Pharmacovigilance division. This is a full-time remote opportunity open to candidates with relevant experience in regulatory writing, aggregate safety reporting, and clinical documentation. The role focuses on high-value medical writing deliverables including PSUR, PBRER, RMP, DSUR, and clinical narratives, making it one of the most in-demand roles in drug safety and regulatory affairs careers.

Company Overview

Parexel is a globally recognized Clinical Research Organization (CRO) that provides end-to-end clinical development, regulatory consulting, and pharmacovigilance services to pharmaceutical, biotechnology, and medical device companies. With decades of expertise and a strong global presence, Parexel plays a key role in bringing innovative therapies to market while ensuring regulatory compliance and patient safety.

The company is highly regarded for its scientific expertise, regulatory excellence, and contribution to global drug safety and clinical research. Professionals at Parexel work on complex global submissions and gain exposure to international regulatory frameworks, making it a top choice for careers in medical writing and pharmacovigilance.

Job Role & Responsibilities

As a Medical Writer I / II, you will be responsible for preparing high-quality regulatory documents, safety reports, and clinical narratives. This role requires strong analytical skills, scientific writing expertise, and in-depth understanding of pharmacovigilance and regulatory requirements.

Aggregate Reports & Regulatory Writing

• Prepare and update Risk Management Plans (RMPs) and Company Core-RMPs (CC-RMPs)
• Develop aggregate safety reports including PSUR, PBRER, DSUR, PADER, ACO, IND Annual Reports, and safety evaluation reports
• Conduct systematic literature reviews focusing on epidemiology, incidence, and risk factors
• Develop literature search strategies and support epidemiological data analysis
• Generate line listings and ensure data consistency across reports
• Perform quality review checks to ensure accuracy and compliance of all regulatory documents

Clinical Narratives & Study Support

• Prepare clinical study report (CSR) narratives using clinical and safety databases
• Ensure medical accuracy, coherence, and regulatory compliance in narratives
• Coordinate with study teams and stakeholders for narrative development and review
• Perform quality control checks and finalize narrative documentation

Signal Detection & Safety Analysis

• Conduct signal detection and safety data analysis from multiple sources
• Manage end-to-end signal evaluation and tracking processes
• Collaborate with global safety teams to support risk assessment activities

General Responsibilities

• Maintain knowledge of global pharmacovigilance regulations and reporting requirements
• Ensure timely submission and compliance with regulatory timelines
• Participate in audits, inspections, and training programs
• Collaborate with clients and stakeholders to deliver high-quality outputs
• Mentor junior writers and support team development

Eligibility / Qualifications

Educational Qualification

Candidates must have a degree in Life Sciences or healthcare disciplines.

Required courses include:
B.Pharmacy, M.Pharmacy, Pharm.D, MBBS, BDS, BSc, MSc (Biotechnology, Microbiology, Biochemistry, Life Sciences), Nursing, Physiotherapy, Biomedical Sciences

Experience

• Experience in medical writing, pharmacovigilance, or regulatory affairs preferred
• Experience with aggregate reports and safety documentation is highly desirable

Skills Required

• Strong scientific and medical writing skills
• Knowledge of pharmacovigilance regulations and aggregate reporting
• Excellent analytical and problem-solving abilities
• Strong communication and stakeholder management skills
• Ability to manage multiple projects and meet deadlines
• Proficiency in MS Office and web-based tools

Location & Salary

• Job Location: Remote (India)
• Employment Type: Full-time
• Salary: Competitive salary based on experience in medical writing and pharmacovigilance roles

Application Process

Interested candidates can apply through the official Parexel careers portal:

Apply Here: https://jobs.parexel.com/en/job/-/-/877/93415699696

Frequently Asked Questions (FAQs)

1. Who can apply for this role?

Candidates with Life Sciences, Pharmacy, Medicine, or related healthcare degrees can apply.

2. Is prior experience required?

Yes, experience in medical writing, pharmacovigilance, or regulatory documentation is preferred.

3. What documents will I work on?

You will work on PSUR, PBRER, DSUR, RMP, clinical study reports, and safety narratives.

4. Is this a remote job?

Yes. This is a remote opportunity within India.

5. What is the career growth?

You can progress to Senior Medical Writer, Regulatory Writer, or Pharmacovigilance Lead roles.

Summary Table

Category	Details
Company	Parexel
Vacancies	Medical Writer I / Medical Writer II
Required Education	B.Pharmacy, M.Pharmacy, Pharm.D, MBBS, BDS, BSc, MSc (Biotechnology, Microbiology, Biochemistry, Life Sciences), Nursing, Physiotherapy, Biomedical Sciences
Experience	Relevant Medical Writing / PV Experience Preferred

Tagged as: Pharma Jobs in Bangalore