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 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 p rovides 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.

Internal:  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!

• 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