Sr. Associate, Basic Results Author

ROLE SUMMARY

The Clinical Trial Results Author is responsible for the preparation, authoring, review, and maintenance of clinical trial results disclosures for public registries including ClinicalTrials.gov, the Clinical Trials Information System (CTIS), and EudraCT.

 

The role works closely with Clinical Trial Disclosure Managers, Clinicians, Statisticians, Programmers, Medical Writing, and Study Teams to ensure timely, accurate, and compliant disclosure of clinical trial results. The individual authors Basic Results (BR) by transforming clinical study data and statistical outputs into compliant results records while ensuring adherence to applicable regulations, quality standards, and standard operating procedures.

ROLE RESPONSIBILITIES

·        Author ClinicalTrials.gov Basic Results records in PRIME.

·        Prepare and maintain:

o   Participant Flow

o   Baseline Characteristics

o   Outcome Measures

o   Adverse Events

o   Limitations and Caveats

o   Certain Agreements and Results Point of Contact sections.

·        Review source documents including Protocol, SAP, CSR, and statistical tables as supporting documents for preparing basic results.

·        Work with Cross functional groups Clinical trial disclosure manager, clinicians, legal and statisticians for preparing basic results to resolve data questions and ensure accuracy.

·        Address quality review comments and support responses to ClinicalTrials.gov reviewer comments.

·        Ensure results are completed within disclosure timelines and in compliance with regulatory requirements.

·        Support process improvements, training materials, and authoring best practices.

·        Maintain audit-ready documentation and evidence.

·        Ensure compliance with:

o   FDAAA 801

o   42 CFR Part 11

o   EU CTR 536/2014

o   EU CTD 536/2014

o   Internal disclosure procedures.

 

BASIC QUALIFICATIONS

• Work is achieved by individual or through project teams, utilizing technical or subject matter expertise to achieve results. Requires relevant scientific education, skills, and knowledge
• Bachelors or Master's degree in Life sciences, Pharmacy, Biomedical Sciences, Clinical Research, or related fields.
• 3+ years with Bachelors degree, or 1+ years with Master's degree of Basic Results (BR) authoring, Medical writing, Clinical trial disclosure and/or Transparency operations experience.

• Requires strong understanding of the principles of the discipline and applies these skills and departmental knowledge to achieve assigned work
• Begins to apply experimentation and use of new ideas
• Contributes to the completion of moderately complex projects across a work team
• Makes decisions to resolve moderately complex problems with short term impact within work team
• Works under general supervision using own judgment where needed
• Project management and organizational skills.
• Understanding of global disclosure regulations and guidelines.
• Excellent communication and stakeholder management abilities.
• Analytical and critical thinking skills with attention to detail.
• Ability to work cross-functionally, managing ambiguity and conflicting priorities.
• Strong interpersonal skills.
• Flexibility to work across therapeutic areas and development phases.
• Medical research background with breadth and depth of knowledge of clinical trial disclosure preferred
• Ability to work effectively across cultures and time zones.

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PREFERRED QUALIFICATIONS

• Experience with Xogene Prime application is a plus.
• Experience with quality checking AI outputs

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

 

Flexibility to work with colleagues across various time zones in the world.

 
Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

 

 

Medical