Data Transparency Document Anonymization Director 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/.
We are seeking a Data Transparency Document Anonymization Director to join our Clinical Data Standards & Transparency team/ Innovative Medicine, to be located within commutable distance of one of the following J&J sites: High Wycombe, United Kingdom; Beerse, Belgium; Allschwil, Switzerland; Breda, Netherlands; or, Spring House / Raritan / Titusville, US. Remote working options may also be considered on a case-by-case basis and if approved by the business.
The Data Transparency Document Anonymization Director provides strategic oversight of document anonymization policies and procedures across the business and comprises technical, financial, and management responsibilities. Responsible for global document anonymization to protect personal patient and trial participant information and to safeguard confidential commercial information (CCI). Responsible for policies and procedures for all Innovative Medicine clinical documents made public to registries, journals, and under health authority publication policies, and provided to researchers under the YODA Project. Health authority policies include EU Clinical Trials Regulation (CTR), EMA Clinical Data Publication, and Health Canada Public Release of Clinical Information.
Also responsible for processing clinical and nonclinical documents provided under freedom-of-information laws in Europe and elsewhere.
Principal RelationshipsInternal: Global Development (clinical trial startup, performance, oversight, and results reporting), Medical Writing (document templates and clean authoring), Therapeutic Areas (SMEs for CCI review and training), Legal and Patent Department (CCI protection policies and procedures), Bioethics and Privacy (data transparency policies and privacy principles).
External: Vendors (document anonymization), Industry Associations (shaping industry practice and regulatory publication policies).
Are you interested to join our team? Then please read further!
Role Responsibilities:Strategic oversight of document anonymization policies and procedures across JRD.Management of Data Transparency Regulatory Document associates.Development and improvement of global policies supporting document anonymization.Development and improvement of global procedures supporting document anonymization.Strengthening of CCI protection procedures across therapeutic areas.Planning and budgeting of document anonymization activities, including vendor management and oversight.Help shape industry best practices on document anonymization by contributing to industry forums (eg, PHUSE, EFPIA).Help shape regulatory policies on document publication by contributing to industry forums.Contribute to Janssen best practices on data transparency, policies on sharing of individual patient data, and use of plain language summaries.Provide input on Innovative Medicine best practice for registering clinical trials and publishing summaries of clinical trial data.Qualifications & Experience:PhD or other advanced degree in a scientific discipline required (biological, chemical, medical, or statistical discipline preferred).At least 10 years' of relevant pharmaceutical/scientific experience (in clinical development or medical writing preferably).At least 10 years' of people management experience.Expertise in principles and practice of clinical data transparency.Detailed knowledge of document anonymization, including both qualitative and risk-based quantitative approaches.Knowledge of all stages of the clinical development process and the documents associated with each stage of development.Strong skills with project management software such as Excel or monday.com preferred.Benefits:We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority. We offer career development opportunities for those who want to grow and be part of our organization.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For United States Applicants: The anticipated base pay range for this position is $ to $. 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 corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be 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.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). US Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year; Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year; Holiday pay, including Floating Holidays - up to 13 days per calendar year; Work, Personal and Family Time - up to 40 hours per calendar year.
For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits. The compensation and benefits information set forth in this posting applies to candidates hired in the United States only. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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