Manager, Aggregate Reports Scientist

Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health

Position summary

This role is open to be conducted in an of the following locaitons: High Wycombe; United Kingdom, Stokholm; Sweden, Allschwill; Switzelrand, New Brunswick; NJ, Jacksonville; FL or Lancaste; PA; USA.

The Manager Aggregate Reports Scientist (ARS) will support the scheduled post-marketing aggregate report results and work in close collaboration with other partners to collect, interpret, and incorporate data from a variety of sources into the reports to properly communicate the benefit-risk of the product.

You will have solid understanding of the industry regulations and guidance for scheduled aggregate reports and a broad understanding of content needed for the reports. Serving as product point of contact and lead cross-functional teams in the production of aggregate reports, providing guidance on content, processes, timelines, and scientific integrity to ensure well-written reports.

You are able prepare and/or provide training to, and oversight of results produced by, other team members. Additionally, be a key contributor to process and content improvements for these reports.

You will independently, link discussions to content, and deliver quality results with minimal to moderate guidance. You will build alliances and be able to influence safety partners to shape decisions/outcomes.

Principal responsibilitie

• Applying working knowledge of PV regulations and purpose of the scheduled aggregate reports
• Effectively partnering with others and leading the production of the scheduled aggregate report to ensure high quality safety reports and to optimize data retrieval
• Ensuring health authority (HA) requests/Assessment Reports have been addressed as required in scheduled aggregate reports
• Reviewing and/or writing safety topics for scheduled aggregate reports for applicable products (e.g., Established Products)
• Interpreting and integrating information in a clear, concise manner
• Developing conclusions based on all information for applicable products

Act as ad hoc member of SMT for assigned products collaborate with Safety Analysis Scientist for the preparation of scheduled aggregate reports

Participate in cross-functional training of relevant partners, and department training of ARS on activities within the role.

Contribute in, and/or lead department and/or cross-functional initiatives and explore innovative ways of presenting data, preparing reports, and improving efficiencies.

Assist in the creation, review and implementation of controlled documents and other related tools.

Decision-making and problem-solving:

The primary decision-making responsibility centers around a detailed understanding of aggregate safety reports (ASR), international pharmacovigilance regulations, and company procedures. The Manager ARS will function independently and able to recognize potential safety issues and raise as appropriate, think strategically with respect to data interpretation, and understand the nature of adverse drug reactions and complex associations. In addition, You will need to understand partner/customer needs, be able to build alliances and influence other groups, and have a high level of flexibility and attention to detail.

Working relationships

This position works closely with many groups including Global Medical Safety, Medical Affairs, Global Regulatory Affairs, Clinical, Compliance, Standards and Analytics, Epidemiology, International Pharmacovigilance, Regulatory Medical Writing, the vendor, and business partners. Specific roles may include Global Regulatory Leader, Compound Development Team Leader, Therapeutic Area Safety Head, Clinical Leader/Development Head, Medical Safety Surveillance and Insight Physicians and Staff and Scientists, Data Analytics/GMS Support Desk Staff.

Qualifications

We are looking for candidates who meet the following education & experience requirements:

• Bachelor’s Degree Required: Healthcare-related or Biomedical Science
• Advanced Degree Preferred: Healthcare-related / Biomedical Science
• Medical writing or PV experience required!
• Clinical experience preferred

Required Skills:

• Knowledge of global regulatory framework for ASR & experience in developing aggregate safety reports (e.g., PBRER)!
• Solid understanding of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements
• Ability to understand and analyze complex medical-scientific data from a broad range of subject areas
• Ability to interpret and present complex data to resolve benefit-risk impact
• Excellent English verbal and written communication skills
• Ability to effectively contribute in a multiple reporting line environment, shown leadership skills
• Ability to plan work to meet timelines and effectively prioritise multiple priorities
• Proficiency in Microsoft applications (e.g., Word, Excel, PowerPoint)
• Ability to influence and connect with both internal and external customers

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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.

Primary Location
United Kingdom-England-High Wycombe-
Other Locations
North America-United States-New Jersey-New Brunswick, North America-United States-Florida-Jacksonville, North America-United States-Pennsylvania-Lancaster, Europe/Middle East/Africa-Sweden-Stockholm-Solna, Europe/Middle East/Africa-Switzerland-Allschwil
Organization
Janssen Cilag Ltd. (7360)
Job Function
R&D
Requisition ID
2105956468W