Manager, Standards Management (DASTFL)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a Manager Standards Management Expert (DAS/TFL) within Integrated Data Analytics & Reporting (IDAR) to provide expert guidance and tailored solutions on projects programs and processes that span multiple related areas in support of the organizations overall Clinical Data Standards strategy. The Standards Management Expert (DAS/TFL) is an individual contributor who takes a leadership role in the collaboration with various internal and external partners to ensure consistency of clinical data standards across clinical trials and in compliance with regulatory requirements.

This role may be located in High Wycombe UK; Beerse Belgium; Leiden Netherlands; Allschwil Switzerland; Titusville United States; or Mumbai India (Hybrid: 3 days pw onsite)

Please note that this role is also available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

United Kingdom - Requisition Number: R-046152
Belgium/Netherlands - Requisition Number: R-047951

Switzerland Requisition Number: R-071854

India Requisition Number: R-071859

United States Requisition Number:R-071857

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

Purpose:

• Acts as a top-level specialist to establish programs and innovative strategies that advance the Clinical Data Standards organization
• Manages standards projects programs or processes for Clinical Data Standards in line with agreed internal strategy and regulatory requirements.
• Participates in the development of solutions to provide accurate timely and consistent clinical data standards to study teams.
• Communicates ideas for process improvement while supporting the design and integration of new technologies to enhance clinical data standards.
• Coaches and trains junior colleagues in clinical data standards application and responsibilities.
• Integrates Johnson & Johnsons Credo and Leadership Imperatives into team goals and decision making.

You will be responsible for:

Manager Standards Management Expert (DAS/TFL) is responsible for the development and maintenance of clear specifications for standard content across the data lifecycle including data collection delivery analysis & reporting aligned with program requirements and medical writing. Examples of standard content:

• Supportive documentation to guide and support consistent adoption of standards in clinical trials.
• Standard text definitions and analysis requirements that are included in the Protocol andStatistical Analysis Plan
• Standard tables listings and graph mock displays along with detailed analysis requirements andstandard analysis rules included in the Data Presentation Specifications
  

The role is responsible for acquiring and maintaining deep expertise in the various data collection and analysis tools and templates applied in the clinical trials specifically those in use in J&J (e.g. AUTOCODE) in industry standards including but not limited to CDISC standards and adjacent data standards (e.g. HL7 / FHIR OHDSI/OMOP).

The role should be knowledgeable in using common clinical data tools such as LSAF Pinnacle 21 or SAS. The position may also be involved in innovative projects which requires learning of new tools and standards.

The role is responsible for remaining aware of the industry standards development and trends and regulatory requirements to support the development strategy and evolution of the J&J.

The role may also have responsibility for providing operational expertise in cross functional initiatives.

Qualifications / Requirements:

• A Bachelors degree in a scientific technology or healthcare discipline or equivalent experience. Advanced degrees preferred (e.g. Master PhD)
• At least 6 years of relevant pharmaceutical/scientific experience in a related discipline; e.g. data management biostatistics clinical or statistical programming
• Expert knowledge of relevant regulatory requirements (e.g. GCP ICH) and industry standards (e.g. SDTM ADaM)
• Demonstrated written and verbal communications skills
• Demonstrated customer focus and solution-oriented experience
• Demonstrated interpersonal skills to build relationships with internal and external business partners
• Demonstrated leadership on cross-functional projects
• Demonstrated leadership in decision making and problem solving
• Excellent spoken and written English
• Ability to commute to one of the aforementioned office locations.

Benefits

For United States Applicants:

The expected pay range for this position is $117000 to $201250.

The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/ performance year. Bonuses are awarded at the Companys discretion on an individual basis.

• Subject to the terms of their respective plans employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short and long-term disability business accident insurance and group legal insurance.

• Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Companys long-term incentive program. Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

  • Vacation 120 hours per calendar year

  • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year

  • Holiday pay including Floating Holidays 13 days per calendar year

  • Work Personal and Family Time - up to 40 hours per calendar year

  • Parental Leave 480 hours within one year of the birth/adoption/foster care of a child

  • Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

  • Caregiver Leave 80 hours in a 52-week rolling period10 days

  • Volunteer Leave 32 hours per calendar year

  • Military Spouse Time-Off 80 hours per calendar year

For additional general information on company benefits please go to: job posting is anticipated to close on April 10th 2026. The Company may however extend this time-period in which case the posting will remain available on to accept additional applications.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

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