HireDiversity

Horsham, PA, US

Global Medical Safety Risk Management Scientific Lead-9467121115

Description

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is recruiting for a Global Medical Safety Risk Management Scientific Lead. This position can be located in any of the following locations: Horsham, PA, Titusville, NJ, Raritan, NJ, Morris Plains, NJ, High Wycombe, UK or Beerse, Belgium.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Global Medical Safety (GMS) Risk Management Scientific Lead (RMSL) is responsible for providing strategic and operational risk management support to Safety Management Teams (SMTs) across the Therapeutic Areas (TAs).

The RMSL supports key projects as co-lead, with the SMT Chair, for risk management-related activities, including the development of product core risk management strategies, and the development, implementation and maintenance of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). In addition, this role provides input on the risk management component of other related safety documents (e.g. PSUR). These activities are accomplished in close collaboration with other (ad hoc) SMT members from Medical Affairs, Clinical Development, Regulatory Medical Writing, Regulatory Affairs and other functions, as needed.

The RMSL works closely with the SMTs to ensure a consistent approach to risk management across the Pharma portfolio, as well as compliance with Company policies and global pharmacovigilance (PV) regulations. The RMSL helps to ensure a harmonized, global approach to benefit-risk decision making, thereby assisting teams in making informed product-specific safety and risk management decisions.

Apart from product-level responsibilities, as a Company expert on global risk management, the RMSL also contributes to or leads cross-functional teams to develop and promote best practices, process, tools, policies and intelligence repositories to accomplish the following: promote consistent safety risk management excellence across Janssen R&D, ensure safe and appropriate use of Janssen R&D products, and monitor performance trends and drive continue process improvements on Risk Management.

RMSL product-level activities may include any or all of the following: conduct risk topic research (other company products, regulatory intelligence, and competitive intelligence); formulate recommendations for risk management strategy, including PV and/or risk minimization activities; benchmark risk management strategies and recommendations against cross portfolio learnings; coordinate and execute preplanning meeting and/or risk management meetings during document development cycle; proactively identify and resolve issues; establish and lead sub teams and projects (e.g. early development risk management sub team); focused risk management document review (e.g., template compliance review; cross-document consistent reviews - e.g., RMP, PSUR, DSUR) and core team participation for SMT meetings in support of risk management activities.

Additionally, RMSL core support responsibilities will include: prepare and deliver EU-RMP Annex I form; coordinate and execute RMP Lessons Learned Program; implement and support new policies, standard operation procedures (SOPs), tools, etc., and provide consulting support to address ad hoc questions and issues. The RMSL will also have responsibility for cross-product/therapeutic area activities, including: develop and promote best practices, process, tools, policies and intelligence repositories to ensure consistent safety risk management excellence across the organization; provide information and training across the organization, e.g. maintain and share current knowledge of evolving global regulatory risk management requirements; and lead or coordinate provision of feedback to Health Authorities on draft guidances and other regulatory initiatives as necessary and supported by GMS management.

In partnership with Risk Management Group Strategic Operational Lead, the RMSL will also have responsibility for identifying, exploring, and pursuing innovative risk management opportunities through internal and external partnerships.

Qualifications


A minimum of a PharmD, PhD, MSc. Degree, or advanced degree in other clinically oriented biomedical science is required for this position. A minimum of 5 years of pharmaceutical industry experience with a minimum of 3 years of experience in pharmacovigilance is also required.

Broad scientific and safety experience in evaluating clinical development and postmarketing safety data, and excellence in scientific analysis and presentation, as well as good understanding of principles of drug development and global pharmacovigilance regulations is required.

Proven ability to effectively interface with global internal and external stakeholders, including Business Partners, and the ability to manage/lead in a matrix environment is required and key for success in this position.

Subject matter expertise helpful to succeed in this role includes: in depth knowledge of global regulatory framework for Risk Management and experience in developing risk management strategies and/or risk management related documents.

Other required skills and abilities include: excellent verbal and written communication skills; proven leadership skills; ability to plan work to meet deadlines and effectively handle multiple priorities; fluency in written and spoken English; and proficiency in Microsoft Word, Excel and PowerPoint.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Morris Plains
Organization: Janssen Research & Development, LLC. (6084)