Sr. Analyst Clinical Data Transparency

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 ;br>
Job Function:
Data Analytics & Computational Sciences

Job Sub Function:
Data Governance & Policy

Job Category:
Professional

All Job Posting Locations:
High Wycombe, Buckinghamshire, United Kingdom, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America, Toronto, Ontario, Canada

Job Description:

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 ;br>
We are searching for the best talent for a Senior Analyst, Clinical Data Transparency to be in located in either: US (Raritan, NJ, Springhouse, PA, Titusville, NJ,); Toronto, Canada; Beerse, Belgium; Leiden, Netherlands; or High Wycombe, Great Britain.

Purpose:

The Sr. Analyst Clinical Data Transparency is responsible for coordinating operational aspects of anonymization activities for data transparency deliverables, and serves as a subject matter expert and single point of contact for the business community. Data transparency deliverables include anonymized documents for Policy 043, Policy 70, PRCI, EU CTR, YODA, Journal requirements, Registry Regulations, PMDA, etc. This position closely collaborates across multiple functional areas (eg, Data Sharing, Submission Management, Regulatory Affairs, Regulatory Medical Writing, Risk Management, Registry, Publication Planning, etc.) to ensure transparency deliverables are completed per process requirements and by required due date. The Sr. Analyst Clinical Data Transparency works closely with anonymization providers (eg, Privacy Analytics) to ensure the documents are anonymized or redacted as expected per the data transparency process. Leads or participates in special projects that shape the current and future data transparency landscape. The Sr. Analyst Clinical Data Transparency also shapes and contributes to technological solutions for managing and tracking data transparency deliverables.

The Sr. Analyst Clinical Data Transparency makes decisions that can have an impact on submission operational guidelines, Clinical data transparency guidelines, standards, and processes.

The Sr. Analyst Clinical Data Transparency works with limited supervision as a member of a team when making recommendations and decisions. This position contributes to decisions that have an impact on the quality and timeliness of moderate to complex data transparency deliverables. The Sr. Analyst Clinical Data Transparency makes decisions on transparency operational strategies for the best project management approach within process/timeline/resource constraints/technical issues/ability of vendor to deliver. This position makes recommendations that impact data transparency processes, technology solutions, and interpretation of guidance in regard to transparency deliverables.

Knowledge/Skills:

• In-depth understanding of the data transparency processes, and guidances that impact those processes.
• Effective interpersonal, teamwork, and communication skills.
• Ability to work or lead in a matrix environment and influence stakeholders.
• Knowledge of Regulatory Information Systems, planning, project management, and tracking tools.
• Knowledge of eCTD and ICH E3 format and standards.
• Knowledge and skills to build productive relationships across the organization and with external stakeholders.
• Demonstrated problem solving, troubleshooting, and adaptability.
• Proficiency in submission related HA and Industry regulations and guidelines as relevant.

The Sr. Analyst Clinical Data Transparency reports to the Director of IDAR Data Transparency Document Sharing. This position may oversee the work of others without a direct reporting relationship. The Sr. Analyst Clinical Data Transparency mentors and guides internal and external colleagues.

You will be responsible for:

• Coordinates operational aspects of anonymization activities such as, collecting content that will need to be anonymized from identified PoCs, partner with anonymization provider in getting content anonymized, issue and release of anonymized content.
• Advanced knowledge of personally identifiable information and various anonymization techniques to protect patient privacy.
• Participates in dossier team meetings by bringing forward key communications from anonymization provider, strategy based on knowledge of regulations, and development of documents, such as annex of submitted documents and out of scope sections.
• Assists with scoping of PRCI-CDP submissions and ensures documents are delivered for publishing to meet Health Authority deadlines.
• Performs a dossier review of the submission.
• Ensures data transparency deliverables are tracked and/or published using appropriate systems/tools.
• Develops or contributes to data transparency work practices, process enhancements / improvements, and associated training materials.
• Takes a leadership role for the monitoring and effectiveness of the data transparency processes and initiates changes within the scope of decision-making authority to minimize inefficiencies and ensure / improve quality.
• Takes a proactive role on multiple projects with respect to timing, scheduling, tracking, and strategy. Promotes understanding of end-to-end process flow, upstream and downstream effects, and develops consistency across data transparency deliverables.
• Applies appropriate data transparency standards, requirements, processes, and policies to comply with applicable health agency requirements.
• Cultivates ongoing effective relationships across GRA as well as cross-functionally. Maintains open communications with key partners to ensure priority conflicts, resource issues, and deviations from the plan are identified and resolved.

Required Education and Experience:

• A bachelor's degree in a scientific, technology or healthcare discipline or an individual without a degree may be considered with 5 to 8 years relevant pharmaceutical experience
• At least 3 years of relevant pharmaceutical/scientific experience in a related discipline e.g. medical writing, clinical trial management, regulatory submissions, document publishing
• Strong understanding of at least one of the following: clinical trial or submission disclosure requirements, anonymization of clinical data and documents

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):

• Titusville, NJ, Raritan, NJ and Springhouse, PA- Requisition #: R-015514
• Beerse, Belgium and Leiden, Netherlands -Requisition #: R-016719
• High Wycombe, Great Britain- Requisition #: R-016717
• Toronto, Canada- Requisition #: R-016709

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

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 and 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 email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :
$91,000-$147,200

Additional Description for Pay Transparency:
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)). This position is eligible to participate in the Company's long-term incentive program. 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 of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. 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.