Pfizer is hiring for the position of Sr. Associate, Basic Results Author in Chennai, India. The role focuses on preparing, authoring, reviewing, and maintaining clinical trial results disclosures for public registries including ClinicalTrials.gov, CTIS, and EudraCT.
Job Details
| Job Detail | Information |
|---|---|
| Company | Pfizer |
| Position | Sr. Associate, Basic Results Author |
| Location | Chennai, India |
| Employment Type | Full Time |
| Work Model | Hybrid |
| Job Requisition ID | 4964791 |
Position
Sr. Associate, Basic Results Author
The Clinical Trial Results Author is responsible for transforming clinical study data and statistical outputs into compliant clinical trial results records while ensuring accuracy, quality, regulatory compliance, and adherence to standard operating procedures.
Responsibilities
- Author ClinicalTrials.gov Basic Results records in PRIME.
- Prepare and maintain:
- Participant Flow
- Baseline Characteristics
- Outcome Measures
- Adverse Events
- Limitations and Caveats
- Certain Agreements and Results Point of Contact sections.
- Review Protocol, SAP, CSR, and statistical tables as supporting documents.
- Work with Clinical Trial Disclosure Managers, clinicians, legal teams and statisticians to resolve data questions and ensure accuracy.
- Address quality review comments and support responses to ClinicalTrials.gov reviewer comments.
- Complete clinical trial results within disclosure timelines.
- Support process improvements, training materials, and authoring best practices.
- Maintain audit-ready documentation and evidence.
- Ensure compliance with FDAAA 801, 42 CFR Part 11, EU CTR 536/2014, EU CTD 536/2014, and internal disclosure procedures.
Eligibility / Qualifications
- Bachelor’s or Master’s degree in:
- Life Sciences
- Pharmacy
- Biomedical Sciences
- Clinical Research
- Related fields
- With a Bachelor’s degree: 3+ years of Basic Results authoring, medical writing, clinical trial disclosure and/or transparency operations experience.
- With a Master’s degree: 1+ years of Basic Results authoring, medical writing, clinical trial disclosure and/or transparency operations experience.
- Understanding of global disclosure regulations and guidelines.
- Project management and organizational skills.
- Strong communication and stakeholder management abilities.
- Analytical and critical-thinking skills with attention to detail.
- Ability to work cross-functionally while managing ambiguity and conflicting priorities.
- Ability to work across therapeutic areas and development phases.
- Ability to work effectively across cultures and time zones.
Required Skills
Candidates should have:
- Clinical trial disclosure knowledge.
- Basic Results authoring experience.
- Medical writing or transparency operations experience.
- Knowledge of clinical trial disclosure regulations.
- Strong analytical and critical-thinking abilities.
- Excellent communication and interpersonal skills.
- Strong organizational and project management skills.
- Attention to detail.
- Cross-functional collaboration skills.
- Ability to manage ambiguity and conflicting priorities.
Preferred Qualifications
- Experience with Xogene Prime application.
- Experience with quality checking AI outputs.
- Medical research background with breadth and depth of knowledge of clinical trial disclosure.
Application Details
