Sr. Associate, Basic Results Author
Sr. Associate, Basic Results Author
Pfizer
Job description
Looking to build a career in clinical trial results disclosure? Explore this Sr. Associate, Basic Results Author role at Pfizer in Chennai.
Company Description
Pfizer is a global healthcare company with a culture of individual ownership. The team believes in its ability to improve future healthcare and transform millions of lives. Pfizer looks for talent to join the Pfizer global community and to find new therapies that make the world a healthier place. Its teams work together across time zones and cultures.
Job Summary
This hybrid role is based in Chennai. As a Sr. Associate Basic Results Author, you will maintain clinical trial results for public registries such as ClinicalTrials .gov, CTIS, and EudraCT. You will turn study data and statistical outputs into results records that follow all the rules. You will work closely with disclosure managers, clinicians, statisticians, programmers, and study teams.
Key Responsibilities
Write ClinicalTrials .gov basic results records in the PRIME system.
Prepare and maintain the Participant Flow, Baseline Characteristics, Outcome Measures, and Adverse Events sections.
Prepare and maintain the Limitations and Caveats section and the Certain Agreements and Results Point of Contact section.
Review source documents such as the protocol, SAP, CSR, and statistical tables.
Work with disclosure managers, clinicians, legal teams, and statisticians to solve data questions.
Fix quality review comments. Help respond to ClinicalTrials .gov reviewer comments.
Complete results within disclosure time limits.
Help with process improvements, training materials, and good writing practices.
Make sure documents and proof are prepared for audits.
Follow FDAAA 801, 42 CFR Part 11, EU CTR 536/2014, and internal disclosure procedures.
Educational Qualification
Bachelor's or Master's degree in life sciences, pharmacy, biomedical sciences, clinical research, or a related field.
Skills Required
3 or more years of experience with a Bachelor's degree, or 1 or more years with a Master's degree.
This experience should be in basic results authoring, medical writing, clinical trial disclosure, or transparency operations.
Understanding of global disclosure rules and guidelines.
Good project management and organizational skills.
Flexibility to work across therapy areas and trial phases.
A medical research background with knowledge of clinical trial disclosure is preferred.
Experience with the Xogene Prime tool and with quality-checking AI outputs is a plus.
Salary Structure
The estimated salary for the Sr. Associate, Basic Results Author role at Pfizer is ₹7 Lakhs to ₹12 Lakhs per year.
Career Development
This role gives you hands-on experience in clinical trial disclosure, a key area of clinical research. You will also work across therapy areas and trial phases and with teams around the world.
How to Apply
Visit our job portal and search for the Sr. Associate, Basic Results Author role at Pfizer.
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
Market insights & trends
Salary Insights
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Hiring Trends
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