Senior Medical Writer
Senior Medical Writer
Parexel
Job description
Looking to build a career in clinical trial disclosure and transparency? Explore this Senior Medical Writer role at Parexel, based remotely in Bengaluru.
Company Description
Parexel is a leading clinical research organization that works to improve patient outcomes worldwide. The company partners with biopharma companies, medical device makers, and academic institutions to run trials across all phases. It has more than 40 years of experience. Parexel teams focus on compliance, scientific quality, and smooth delivery. It helps bring treatments to patients around the world.
Job Summary
This remote position is based in Bengaluru. Centers on clinical trial disclosure and transparency. As a senior medical writer, you will take ownership of trial registration results postings, plain language summaries, and redaction packages for clients around the world. You will also provide guidance and support to junior writers in their work. This role helps make clinical trial information easy to understand for patients.
Key Responsibilities
Lead the preparation, review, and delivery of trial transparency submissions on your own.
Handle protocol registrations, results postings, and plain language summaries. Lay protocol synopses.
Prepare redaction and anonymization packages, anonymization reports, and CCI justification tables.
Review documents such as protocols, CSRs, investigator brochures, informed consent forms, clinical overviews, and safety reports.
Give clients and internal teams guidance on trial disclosure rules.
Lead clients and give advice on complex regulatory matters.
Manage disclosure projects from start to finish.
Share views and suggestions that help clients make decisions.
Help improve processes and best practices within the disclosure team.
Mentor and train team members on disclosure rules, document writing, and compliance.
Make sure all submissions meet quality standards and rules across different regions.
Educational Qualification
Bachelor's degree in life sciences, health sciences, or a related field, or equivalent professional experience.
Skills Required
Experience in writing with proven skill in clinical trial disclosure and transparency.
The posting does not state the years of experience needed.
Strong knowledge of disclosure rules, including clinicalTrials.gov, EudraCT EU CTR, CTIS EMA Policy 0070, and Health Canada rules.
Wide experience in protocol registration, results reporting, and registry upkeep.
Good grasp of health literacy with the ability to write patient-facing documents.
Strong knowledge of data protection rules for anonymization and redaction.
Skill in finding and justifying PPD and CCI redactions.
Clear spoken communication skills to explain complex rules simply.
Salary Structure
The average salary for a Senior Medical Writer at Parexel in India typically ranges from ₹13.4 Lakhs to ₹16 Lakhs per year.
Career Development
This role gives you a strategic place in clinical trial transparency, with chances to lead client talks and manage complex projects on your own. It also lets you mentor junior writers and help shape best practices within the disclosure team.
How to Apply
Visit our job portal and search for the Senior Medical Writer role at Parexel.
Click on the job posting to see all the details about the job.
Enter your information and add your resume.
Send your application.
Education
Bachelor's Degree
Key Skills
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Hiring Trends
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