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Senior Specialist, Study Report Delivery

3+ years
Not Disclosed
10 Feb. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Specialist, Study Report Delivery
Location: Hyderabad, TS, IN
Position: Hybrid
Company: Bristol Myers Squibb
Job Description:
Bristol Myers Squibb is seeking a Senior Specialist, Study Report Delivery to collaborate with clinical stakeholders and support the development of comprehensive reporting and analytics. This role is crucial for ensuring the accuracy of reports aligned with study protocols, compliance with regulatory requirements, and adherence to a "first-time-right" approach. The specialist will contribute to the growth and success of the organization by supporting clinical teams, developing new reports, and keeping up-to-date with industry trends.

Key Responsibilities:

  • Collaboration: Work with clinical stakeholders to understand their reporting and analytics needs.
  • Requirements Translation: Convert reporting requirements into development specifications with end users.
  • Report Development: Design and develop reports and analytics visualizations according to set specifications.
  • Testing and Review: Conduct testing of developed reports, document results, and provide peer review support.
  • Compliance: Ensure documentation and process compliance; report noncompliance when necessary.
  • Regulatory Knowledge: Stay informed about regulations like ICH, FDA 21 CFR part 11, and GxP.
  • Continuous Improvement: Embrace feedback, work with team members, and enhance knowledge and professionalism.
  • Flexibility: Support global stakeholders across different time zones to ensure continuity.
  • Stay Current: Keep up-to-date with new reporting tools, techniques, and industry trends.

Qualifications:

  • Demonstrated ability to work in a team environment, embracing feedback and collaboration.
  • Ability to manage tasks and prioritize based on clinical study needs.
  • Flexibility to work in a hybrid model and across global teams.
  • Strong communication skills and professionalism.

About Bristol Myers Squibb:

Bristol Myers Squibb is a diversified specialty biopharmaceutical company dedicated to transforming patients' lives through science™. The company promotes an inclusive culture where diverse perspectives drive innovation.

Company Values: Passion, innovation, urgency, accountability, inclusion, and integrity.

How to Apply:

For more details and to apply, please visit: Bristol Myers Squibb Careers