Senior Manager / Associate Director, Standards Technical Integration Lead - 2 openings

Johnson & Johnson•Hopewell Township, NJ

18d•Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com 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 https://www.jnj.com/innovative-medicine We are searching for the best talent for a Standards Technical Integration Lead within Integrated Data Analytics & Reporting (IDAR), to contribute to the Clinical Data Standards team as a leading expert individual contributor, guiding the execution of projects, programs, and processes that span multiple related areas in support of the organization's overall Clinical Data Standards strategy. Purpose: The Standards Technical Integration Lead applies comprehensive knowledge of Clinical Data Standards to install best in class policies, procedures, and plans for the area ensuring consistency of clinical data standards across clinical trials and in compliance with regulatory requirements. The role may be located in Titusville, NJ / Raritan, NJ /Spring House, PA, US; High Wycombe, United Kingdom; Allschwil, Switzerland; Beerse, Belgium; Leiden, Netherlands; Hyderabad / Mumbai, India (Hybrid / 3 days onsite per week preferred). Please note that this role is 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 States - Requisition Number: R-046101 United Kingdom -Requisition Number: R-048105 Switzerland - Requisition Number: R-0488112 Belgium/Netherlands/India - Requisition Number: R-048107 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Requirements

A bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience. Advanced degrees preferred (e.g., Master, PhD)
At least 8 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

Responsibilities

Standards Technical Integration Lead is responsible for applying the strategy and tracking development of standards across the full data lifecycle from data collection through to submission, including standards for CRF, SDTM, ADaM, Reporting, CSR, etc. This may include adjacent data standards like FHIR and OMOP.
This role will analyze requests, assess the impact across the lifecycle, and orchestrate changes across standards teams to deliver a holistic set of standards.
The position prepares trainings for trial teams on standards to ensure understanding and alignment across the full data lifecycle.
Standards Technical Integration Lead is positioned as a leader of the full standards process to ensure successful standards implementation.
Internal: Align, collaborate, advise, and share best practices with other functions and teams in Therapeutic Areas, Global Development, Regulatory Affairs, Data Sciences, Clinical Data Standards and others as needed.
External: Interact and collaborate with vendors. Act as J&J representative for defining process standards and sharing best practices with industry counterparts and working groups, as required.

Benefits

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 corporation’s performance over a calendar/performance year.
Bonuses are awarded at the Company’s 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 Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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 period 10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year