Manager, Standards Management Expert (das/tfl

J&J FAMILY OF COMPANIES

Mumbai, India
Not specified; not specified; competitive salary +...
Hybrid
Expert knowledge of cdisc standards sdtm adam
Experience with clinical data tools lsaf pinnacle 21 sas
Deep expertise in regulatory requirements gcp ich
This role acts as a top-level specialist to establish programs and innovative strategies that advance the Clinical Data Standards organization

Job Summary

  • This role acts as a top-level specialist to establish programs and innovative strategies that advance the Clinical Data Standards organization.
  • The position is responsible for developing clear specifications for standard content across the data lifecycle, including data collection, delivery, analysis, and reporting.
  • Johnson & Johnson offers a competitive salary, extensive benefits package, and a flexible working environment that values work-life balance.

Matching Summary

This role acts as a top-level specialist to establish programs and innovative strategies that advance the Clinical Data Standards organization.

Salary

Not specified; Not specified; Competitive salary and extensive benefits package

Skills & Requirements

Must-have

  • Expert knowledge of CDISC standards SDTM ADaM
  • Experience with clinical data tools LSAF Pinnacle 21 SAS
  • Deep expertise in regulatory requirements GCP ICH
  • Ability to develop standard content for protocols
  • Leadership on cross-functional projects

Nice-to-have

  • Knowledge of HL7 FHIR OHDSI OMOP standards
  • Experience with AUTOCODE tool
  • Innovative project leadership skills
  • Strong coaching and training abilities
  • Customer focus and solution-oriented mindset

Key Requirements

  • Bachelor's degree in scientific, technology or healthcare discipline
  • At least 6 years of relevant pharmaceutical or scientific experience
  • Advanced degrees preferred (Master, PhD)
  • Excellent spoken and written English proficiency
  • Ability to commute to one of the specified office locations

Work Rights

Not specified

Tailored Resume

Cover Letter