At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
The Manager Aggregate Reports Scientist (ARS) will support the scheduled post-marketing aggregate report deliverables and work in 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 a 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 leading cross-functional teams in the production of scheduled aggregate reports, providing guidance on content, processes, timelines, and scientific integrity to ensure well-written reports.
You will prepare and/or provide training to, and oversight of results produced by, other team members. Additionally, as a key contributor to process and content improvements for these reports.
Functioning independently, you can link discussions to content, and deliver quality results with minimal to moderate guidance. Building alliances and be able to influence safety partners to craft decisions/outcomes.
- Applying solid understanding of PV regulations and purpose of the scheduled aggregate reports (SAR)
- Effectively partnering and leading the production SAR to ensure high quality safety reports and to optimize data retrieval
- Ensuring HA requests/Assessment Reports have been addressed as required, reviewing and/or writing safety topics for SAR 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.
The primary decision-making responsibility centers around a thorough understanding of ASR international pharmacovigilance regulations, and company procedures. Functioning independently and can 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, the Manager ARS 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.
Do you meet the education & experience requirements?
- Bachelor’s Degree in a relevant healthcare / biomedical Science with a preference for Advanced degree.
- Medical writing or PV experience
- Clinical experience preferred
Do you have the following skills we require?
- Knowledge of global regulatory framework for aggregate safety reports & 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 fields
- Ability to interpret and present complex data to determine benefit-risk impact
- Ability to optimally interact with partners, including business partners
- Ability to work in a matrix environment, proven leadership skills!
- flexiblitye in planning work to meet timelines and effectively balance multiple priorities
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Ability to influence, negotiate 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.
United Kingdom-England-High Wycombe-
North America-United States
Janssen Cilag Ltd. (7360)