Parexel is a globally renowned clinical research organization dedicated to advancing healthcare by delivering high-quality clinical trial services. With a strong commitment to innovation and inclusivity, Parexel empowers employees to make meaningful contributions to people’s lives. As a Medical Writer at Parexel, you will be part of a team focused on producing clinical research documents, working collaboratively in a supportive and growth-oriented environment.

Responsibilities in the Role

As a Medical Writer I at Parexel, your role encompasses diverse responsibilities, including:

1. Aggregate Reports:
   • Preparing and managing various safety reports such as PSURs, PBRERs, DSURs, and RMPs.
   • Conducting systematic reviews and epidemiological analyses to support drug safety reports.
   • Ensuring data consistency and integrity across all reports.
2. Clinical Study Report Narratives:
   • Drafting clear and accurate narratives based on clinical and safety database outputs.
   • Performing quality checks and ensuring cohesive medical assessments.
3. Signal Detection and Management:
   • Analyzing safety signals from various sources.
   • Managing the end-to-end signal process, including tracking and presenting findings.
4. General Responsibilities:
   • Liaising with clients, ensuring compliance with global regulatory standards.
   • Mentoring new recruits and contributing to team training.
   • Supporting audits and inspections while maintaining high-quality deliverables.

Qualifications

To qualify for this role, you need the following educational background:

• Mandatory: A degree in Life Sciences, Health, or Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology).
• Preferred: Degrees in Medicine, Dentistry, Physiotherapy, or Nursing with hospital-based exposure.

Skills Required

Success in this role requires a combination of technical expertise and soft skills:

1. Core Skills:
   • Strong analytical and problem-solving abilities.
   • Excellent medical writing and data evaluation capabilities.
2. Soft Skills:
   • Adaptable and deadline-oriented with a client-focused approach.
   • Strong interpersonal and organizational skills.
3. Technical Proficiency:
   • Familiarity with MS Office Suite and web-based applications.
   • Knowledge of medical terminologies and global regulatory reporting obligations.

Application Link