Mindblowing Jobs

Sr. Associate, Basic Results Author

By Admin · Clinical Research & Clinical Operations

CHENNAI (IN)HYBRIDPOSTED: 10/7/2026
PHARMAFull-time
HIRING ORGANIZATIONPFIZERBiopharmaceutical / Healthcare
Pfizer

ROLE OVERVIEW

Pfizer is hiring a Sr. Associate, Basic Results Author in Chennai to prepare and maintain clinical trial results disclosures for public registries. The role focuses on accurate, compliant authoring and review of clinical trial results while working with cross-functional study and disclosure teams.

ROLE DEFINITION & RESPONSIBILITIES

  • •Author ClinicalTrials.gov Basic Results records in PRIME
  • •prepare Participant Flow, Baseline Characteristics, Outcome Measures, Adverse Events, Limitations and Caveats, and specified Agreements and Results Point of Contact sections
  • •review Protocol, SAP, CSR and statistical tables
  • •collaborate with Clinical Trial Disclosure Managers, clinicians, legal teams and statisticians
  • •resolve data questions and maintain accuracy
  • •address quality review and ClinicalTrials.gov reviewer comments
  • •complete disclosures within required timelines
  • •support process improvements, training materials and authoring best practices
  • •maintain audit-ready documentation and evidence
  • •comply with FDAAA 801, 42 CFR Part 11, EU CTR 536/2014, EU CTD 536/2014 and internal disclosure procedures

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Biomedical Sciences, Clinical Research or related fields
  • 3+ years with Bachelor's degree or 1+ years with Master's degree in Basic Results authoring, Medical Writing, Clinical Trial Disclosure and/or Transparency Operations
  • understanding of global disclosure regulations and guidelines
  • project management and organisational skills
  • strong communication and stakeholder management abilities
  • analytical and critical-thinking skills with attention to detail
  • ability to work cross-functionally and manage ambiguity and conflicting priorities
  • strong interpersonal skills
  • flexibility across therapeutic areas and development phases
  • ability to work effectively across cultures and time zones

PREFERRED QUALIFICATIONS

  • •Medical research background with breadth and depth of knowledge of clinical trial disclosure

REQUIRED VERIFIED SKILLS

Basic Results authoring
Medical Writing
Clinical Trial Disclosure
Transparency Operations
Global disclosure regulations
Project management
Stakeholder management
Analytical thinking
Critical thinking
Clinical trial disclosure
FDAAA 801
42 CFR Part 11
EU CTR 536/2014
EU CTD 536/2014
PRIME

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting

ORGANIZATION CONTEXT & CULTURE

Pfizer is a pharmaceutical company involved in research and development of medicines and vaccines across therapeutic areas.

TEAM SIZE: 80,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare
Culture: The posting emphasises cross-functional teamwork, flexibility across cultures and time zones, and working under general supervision while using individual judgement.

APPLICATION ADVISORY

Highlight Basic Results authoring, Medical Writing, Clinical Trial Disclosure or Transparency Operations experience according to the degree-specific experience requirement. Emphasise experience with ClinicalTrials.gov results sections, source-document review, global disclosure regulations and cross-functional stakeholder management. If applicable, mention Xogene Prime experience and experience quality-checking AI outputs.
RECOMMENDED TRAINING
1/3
The Fundamentals of Regulatory Affairs

The Fundamentals of Regulatory Affairs

READY TO SUBMIT?

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