Johnson & Johnson Careers
Data Transparency Regulatory Document Lead
Raritan, New Jersey
Requisition ID: 9756190319
Janssen R&D, is recruiting for a Data Transparency Regulatory Document Lead. This position is located in Raritan, NJ or the option of working remote.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.
The Data Transparency Regulatory Document Lead is accountable for the oversight, execution, and management of all Regulatory Medical Writing operational activities and processes within the Data Transparency group. This highly independent position will coordinate with cross-functional partners, Therapeutic Areas, CROs, and vendors to manage the regulatory medical writing (anonymization preparation of all scientific/clinical documents) deliverables in response to global health authority requests, YODA Project, external research collaborations, etc. The position will be responsible (in close collaboration with colleagues and professionals in a matrix structure) to deliver data transparency projects on-time without sacrificing quality. The Data Transparency Regulatory Document Lead may also lead or participate in initiatives related to continuous improvement of internal processes, and additionally, provide colleagues with scientific/strategic knowledge related to regulatory medical writing expertise. Responsibilities include:
- Accountable for the oversight, execution and management of document anonymization preparation within the Data Transparency group, including the day-to-day responsibilities for related regulatory medical writing data transparency programs and deliverables in conformance to relevant laws, guidelines, policies and procedures
- Oversees and manages the activities related to the anonymization of clinical and regulatory documents (CSR, CTD for Clinical Parts and HA response document, etc) with quality
- Contributes to standardize the efficient process for high quality document anonymization work. Be proactive in identifying opportunities for greater productivity and leads in finding and executing flexible solutions. Can lead cross-functional or wider activities for process/business improvement
- Responsible for tasks/deliverables to ensure contents of anonymized documents from vendor or internal resources are accurate and of high quality for assigned project
- Keeps abreast of project status, clinical operating plans, and ongoing and new projects. Helps assesses resource needs and priorities within and across projects.
A Bachelor’s degree is required. An advanced degree (e.g., Masters, PhD, MD) is preferred
A minimum of 12 years in relevant pharmaceutical/scientific experience is required.
At least 10 years of relevant medical writing experience is preferred
At least 2 years of people management experience is preferred
Experience in project management and process improvement is required
In‐depth knowledge of drug development processes and portfolio management is preferred.
Advanced knowledge for multiple TAs/DAs as drug developer, such as ICH guidelines, PMDA’s guidelines and development/treatment guidelines is preferred.
Demonstrated written and verbal communications skills. Demonstrated customer focus and solution-oriented experience is required.
Demonstrated interpersonal skills to build relationships with internal and external business partners is required.
Demonstrated leadership on cross-functional projects is preferred.
Demonstrated leadership in strategic decision making and problem solving is preferred. Anonymization knowledge and software is preferred
May involve minimum travel (<10%)
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Raritan-
Janssen Research & Development, LLC. (6084)