Medical Writer Vacancy at Parexel – Apply Now

Parexel Medical Writer Job Vacancies: Shape the Future of Healthcare

About the Company (Parexel)

Welcome to Parexel, where our shared goal is to improve the world’s health. At Parexel, we are dedicated to providing clinical development solutions that make a difference. From clinical trials to regulatory consulting and market access, each of us at Parexel contributes to the development of therapies that benefit patients worldwide. Our work is personal, driven by empathy, and fueled by a deep conviction in what we do.

Company Vacancies List

Position: Medical Writer I

• Location: Mohali, India
• Time Type: Full-time
• Posted on: Posted 3 Days Ago
• Job Requisition ID: R0000017796

Job Description

Job Purpose:

As a Medical Writer I at Parexel, you will be responsible for the management of scheduled and unscheduled aggregate reports. This includes but is not limited to Periodic Safety Reports (PSRs), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), and more. Your role involves signal detection and management, preparation of narratives associated with clinical trials, and compliance activities related to aggregate reports.

Key Accountabilities:

Aggregate Reports

• Managing scheduled and unscheduled aggregate reports.
• Conducting critical appraisal and systematic review of literature.
• Generating Line Listings, creating drug lists/drug folders, and performing regulatory submissions.

Clinical Study Report Narratives

• Preparing clear and accurate narratives based on clinical and safety database outputs.
• Performing quality checks on drafted narratives.
• Assisting in compilation and formatting of narrative deliverables.

Signal Detection and Management

• Performing signal detection review and analysis.
• Leading end-to-end signal management processes.

General

• Maintaining a good working knowledge of adverse event safety profiles.
• Ensuring compliance with internal and regulatory timelines for adverse event reporting.
• Participating in audits and inspections.

Skills:

• Analytical and problem-solving skills.
• Excellent interpersonal and communication skills.
• Strong organizational and prioritization skills.
• Ability to work collaboratively in a team environment.
• Client-focused approach.
• Ability to manage multiple tasks with attention to detail.
• Fluency in written and spoken English.

Knowledge and Experience:

• Relevant experience in Regulatory/Pharmacovigilance or related field.
• Good knowledge of medical terminologies.

Education:

• Science/Medicine degree in life sciences or biomedical sciences.

Apply online