Join Parexel as a Medical Writer I – Remote

At Parexel, we are united by a shared mission – to improve global health. From clinical trials to regulatory consulting and market access, every solution we provide is driven by a deep commitment to making a difference. Each member of our team plays a vital role in developing therapies that ultimately benefit patients. We approach our work with empathy, dedication, and a personal commitment to excellence.

If you are passionate about contributing to meaningful healthcare advancements, Parexel invites you to apply for the role of Medical Writer I. This is a remote position based in Bengaluru, India, offering an opportunity to work with a global leader in clinical research and pharmacovigilance.

About Parexel

Parexel is a leading global biopharmaceutical services organization, providing a comprehensive range of expertise-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology, and medical device industries. With a focus on innovation and collaboration, Parexel supports the development of life-saving therapies and ensures compliance with global regulatory standards.

Our core values – Quality, Integrity, Collaboration, and Innovation – guide everything we do. When you join Parexel, you become part of a team that is dedicated to improving patient outcomes and advancing healthcare worldwide.

Job Description: Medical Writer I

As a Medical Writer I at Parexel, you will play a critical role in the preparation and management of various pharmacovigilance and regulatory documents. Your work will directly contribute to the safety and efficacy evaluation of pharmaceutical products, ensuring compliance with global regulatory requirements.

Key Responsibilities:

1. Aggregate Report Preparation:
   • Manage scheduled and unscheduled aggregate reports, including:
     • Periodic Safety Update Reports (PSURs)
     • Periodic Benefit-Risk Evaluation Reports (PBRERs)
     • Development Safety Update Reports (DSURs)
     • Risk Management Plans (RMPs)
     • United States Periodic Adverse Drug Experience Reports (PADERs)
     • Clinical Overviews (COs)
     • Investigational New Drug Annual Reports (INDARs)
   • Conduct literature reviews and apply epidemiological methods to support safety reports.
   • Ensure data consistency and integrity across documents.
   • Perform quality checks and compliance monitoring for aggregate reports.
2. Clinical Study Report Narratives:
   • Prepare clear and accurate narratives based on clinical and safety database outputs.
   • Ensure medical cohesiveness and compliance with client and Parexel guidelines.
   • Perform quality checks and assist in compiling narrative deliverables.
3. Signal Detection and Management:
   • Perform qualitative and quantitative signal detection from various sources.
   • Lead signal evaluation meetings and present findings.
   • Collaborate with safety science teams to manage the end-to-end signal management process.
4. General Responsibilities:
   • Maintain up-to-date knowledge of drug safety profiles, labeling documents, and global regulatory requirements.
   • Attend internal and client meetings, draft agendas, and track action items.
   • Mentor new team members and delegate tasks as needed.
   • Ensure timely and high-quality delivery of all work.

Skills and Qualifications:

Essential Skills:

• Analytical and Problem-Solving Skills: Ability to evaluate data and draw independent conclusions.
• Communication Skills: Excellent verbal and written communication in English.
• Organizational Skills: Strong prioritization and time management abilities.
• Technical Proficiency: Familiarity with MS Office Suite (Word, Excel, PowerPoint) and web-based applications.
• Attention to Detail: Ability to manage multiple tasks with precision and accuracy.

Preferred Qualifications:

• Education: A degree in Life Sciences, Health Sciences, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, etc.). A medical degree (MBBS, BDS, Nursing) is an advantage.
• Experience: Prior experience in regulatory writing, pharmacovigilance, or related fields is desirable.
• Knowledge: Familiarity with medical terminologies and global regulatory guidelines.

Why Join Parexel?

• Impactful Work: Contribute to the development of therapies that improve patient lives.
• Global Collaboration: Work with a diverse, multicultural team across the globe.
• Professional Growth: Access to training and development opportunities to enhance your skills.
• Work-Life Balance: Enjoy the flexibility of remote work while being part of a supportive team.

How to Apply

Application Link