Jazz Pharmaceuticals
Associate Director, Global Risk Management (Remote)
Jazz Pharmaceuticals, New Philadelphia, Indiana, United States,
If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharma.com and follow @JazzPharma on Twitter.
The Risk Management Associate Director plays a key leadership role in the GRADS Team, facilitating across functional teams, taking ownership of and acting as the subject matter expert for our external vendors, and supporting the maintenance of risk minimization activities for Jazz pharmaceuticals products globally, including but not limited to: the US REMS and Jazz Success Program in Canada.
The GRADS Risk Management Associate Director will play an integral role in building and developing a high performance Risk Management team, and will provide meaningful input to various workstreams and assist in the delivery of the strategic and operational components of risk minimization. This individual will work closely with REMS Operations, PV Operations (including Global Case Processing), Regulatory Affairs, Channel Operations, Market Research, PV Compliance, GRADS Alliance Management, and other groups within Jazz, as well as external vendors to deliver compliant programs for JP investigational and marketed products.
The GRADS Risk Management Associate Director is accountable for effective working relationships within GRADS, and cross-functionally within the company and its affiliates/subsidiaries to foster smooth, accurate, and timely flow of activities related to Risk Minimization, REMS and PV Operations and GRADS Alliance Management. This role may include line management of direct reports, leading cross-functional matrix teams.
Essential Functions/Responsibilities
Work closely with QQPV office to understand Risk management operational needs.
Provide strategic advice, teachings, and support related to risk management planning, risk management sciences, and risk management tools and resources.
Provide expert, strategic advice on the creation and submission of RMPs and REMS (as appropriate).
Provide expert, strategic advice on executing the requirements of RMP/REMS (including advising on appropriate tools and competent vendors).
Guide and support teams on tracking submissions (including the status).
Serve as the liaison between Global Pharmacovigilance/Regulatory/REMS Operations and cross functional organizations, acting as a Global Risk Management ambassador and domain expert as well as increasing awareness within Global Pharmacovigilance Operations/REMS Operations of cross-functional customer/stakeholder needs and dependencies including external partners.
Support the identification and implementation of continuous improvement efforts and initiatives.
Develop or revise risk management related SOPs as appropriate.
Assist with the development and maintenance of REMS procedures as well as risk minimization activities, in alignment with JP Canada staff.
Facilitate organization-wide understanding of REMS programs across cross functional teams (including but not limited to: Pharmacovigilance, Medical Safety, Commercial, Channel Access, Medical Affairs).
Facilitate and/or lead discussions with business process owners for additional information to address questions in establishing process improvements.
Participate in preparatory discussions related to Regulatory Agency interactions.
Maintain expertise in the regulatory environment, regulations, and requirements for Global Risk Management and REMS and PV activities.
Act as the business subject matter expert for PV & REMS Operations relationships, including liaising with external vendors (including REMS administrator).
Serve as a point of contact for REMS external vendor as it pertains to various processes including adverse event reporting.
Identify opportunities for improvement (resource, process, performance) and affect change, driving implementation of opportunities and mitigating risks in partnership with internal and external stakeholders.
Identify process issues and areas of risk, and escalate as appropriate.
Work with service providers for resolution of operational issues and questions, identifying training needs and opportunities for improvement and supporting implementation in collaboration with internal Jazz stakeholders.
Contribute to the resolution of conflicts at team level or higher and facilitate decision making within the team. Escalate issues utilizing governance models and standard communication plans.
May be responsible for organizing and moderating meetings including authoring minutes/discussion summaries. Solicit items for and setting agendas. Send out draft minutes/summaries for comments to both internal and external stakeholders as appropriate. Distribute final summaries to all participants. Follow up with meeting participants on the resolution of action items from meetings.
Conduct ad hoc/special projects and analyses for GRADS Risk Management leadership.
Provide PV operations support as needed.
GRADS Global Risk Management AD Essential Functions
Adhere to Jazz templates and GxP guidelines for documentation and communications.
Ensures compliance with corporate and departmental policies, standard operating procedures, and timely completion of all assigned training.
Other duties as required to support GRADS Global Risk Management activities and objectives.
Participate in the development and maintenance of GRADS Global Risk Management activity workflow processes, department policies, work instructions, standard operating procedures, and training material when new and/or updated processes are introduced.
May serve as an individual contributor or a project manager for functional projects or workflows.
Mentor and develop team members.
Will have line management responsibility.
Participate in inspections and audits as identified, as well as an active role in maintaining a ways-of-working inspection ready state of operating.
Take responsibility for personal development and continuous improvement including keeping up to date with global pharmacovigilance and REMS current practices, industry standards, legislation, and guidelines.
Work collaboratively with cross-functional teams to evaluate the performance, identify bottlenecks, minimize regulatory risks, and recognize patterns of inefficiencies in current operational processes.
Collaborate effectively with functional teams including but not limited to: Quality Assurance, PV Legal, Pharmacovigilance, Medical Safety, Commercial, Channel Access, Medical Affairs, Procurement and Project Management.
Required Knowledge, Skills, and Abilities
Knowledge of current and emerging regulatory requirements and expectations including EMA GVP Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS.
Knowledge of pharmacovigilance activities and processes, with a preference for experience in more than one PV functional area.
Experience managing relationships with service providers or external business partners.
Excellent teamwork and interpersonal skills are required with ability to effectively collaborate with internal and external contacts, building strong sustainable relationships.
Excellent oral and written communication skills, demonstrating professional maturity (high emotional IQ), confidence and competence.
Ability to work effectively within a matrix organization to achieve desired outcomes.
Track record of effective decision-making.
Excellent conflict management/resolution skills.
Proven ability to demonstrate Jazz values and leadership competencies.
Ability to work across cultures, including in a virtual environment.
Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook).
Team Building, Motivating and Influencing Others without authority.
Promoting Innovation and Process Improvement Maintaining activities.
Negotiation skills, strong analytical skills. Must demonstrate accountability for delivery of results and have good problem-solving and decision-making skills.
Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines.
Required/Preferred Education and Licenses
BA/BS, MS/MA degree in health related or biological science related field, PharmD, RPh, or Nursing, strongly preferred.
A minimum of 6 years’ experience in pharmaceutical safety (Risk Management or PV) required with a minimum of 2 years of people management.
Channel Operations, Market Research and/or REMS Operations experience a plus.
PV Operations experience a plus.
People Manager Excellence
At Jazz, we believe that effective people leadership is essential to our success. Our people managers play a vital role in creating an environment where teams thrive, and individuals reach their full potential. Jazz invests in people managers to ensure they are equipped to drive performance, grow individuals and create belonging. As a result, Jazz people managers champion a culture of collaboration, inclusion, and belonging; ensuring that everyone feels heard and valued. They connect with their teams on a personal level, understanding their unique needs and motivations and providing personalized support to empower every team member to thrive.
#J-18808-Ljbffr
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharma.com and follow @JazzPharma on Twitter.
The Risk Management Associate Director plays a key leadership role in the GRADS Team, facilitating across functional teams, taking ownership of and acting as the subject matter expert for our external vendors, and supporting the maintenance of risk minimization activities for Jazz pharmaceuticals products globally, including but not limited to: the US REMS and Jazz Success Program in Canada.
The GRADS Risk Management Associate Director will play an integral role in building and developing a high performance Risk Management team, and will provide meaningful input to various workstreams and assist in the delivery of the strategic and operational components of risk minimization. This individual will work closely with REMS Operations, PV Operations (including Global Case Processing), Regulatory Affairs, Channel Operations, Market Research, PV Compliance, GRADS Alliance Management, and other groups within Jazz, as well as external vendors to deliver compliant programs for JP investigational and marketed products.
The GRADS Risk Management Associate Director is accountable for effective working relationships within GRADS, and cross-functionally within the company and its affiliates/subsidiaries to foster smooth, accurate, and timely flow of activities related to Risk Minimization, REMS and PV Operations and GRADS Alliance Management. This role may include line management of direct reports, leading cross-functional matrix teams.
Essential Functions/Responsibilities
Work closely with QQPV office to understand Risk management operational needs.
Provide strategic advice, teachings, and support related to risk management planning, risk management sciences, and risk management tools and resources.
Provide expert, strategic advice on the creation and submission of RMPs and REMS (as appropriate).
Provide expert, strategic advice on executing the requirements of RMP/REMS (including advising on appropriate tools and competent vendors).
Guide and support teams on tracking submissions (including the status).
Serve as the liaison between Global Pharmacovigilance/Regulatory/REMS Operations and cross functional organizations, acting as a Global Risk Management ambassador and domain expert as well as increasing awareness within Global Pharmacovigilance Operations/REMS Operations of cross-functional customer/stakeholder needs and dependencies including external partners.
Support the identification and implementation of continuous improvement efforts and initiatives.
Develop or revise risk management related SOPs as appropriate.
Assist with the development and maintenance of REMS procedures as well as risk minimization activities, in alignment with JP Canada staff.
Facilitate organization-wide understanding of REMS programs across cross functional teams (including but not limited to: Pharmacovigilance, Medical Safety, Commercial, Channel Access, Medical Affairs).
Facilitate and/or lead discussions with business process owners for additional information to address questions in establishing process improvements.
Participate in preparatory discussions related to Regulatory Agency interactions.
Maintain expertise in the regulatory environment, regulations, and requirements for Global Risk Management and REMS and PV activities.
Act as the business subject matter expert for PV & REMS Operations relationships, including liaising with external vendors (including REMS administrator).
Serve as a point of contact for REMS external vendor as it pertains to various processes including adverse event reporting.
Identify opportunities for improvement (resource, process, performance) and affect change, driving implementation of opportunities and mitigating risks in partnership with internal and external stakeholders.
Identify process issues and areas of risk, and escalate as appropriate.
Work with service providers for resolution of operational issues and questions, identifying training needs and opportunities for improvement and supporting implementation in collaboration with internal Jazz stakeholders.
Contribute to the resolution of conflicts at team level or higher and facilitate decision making within the team. Escalate issues utilizing governance models and standard communication plans.
May be responsible for organizing and moderating meetings including authoring minutes/discussion summaries. Solicit items for and setting agendas. Send out draft minutes/summaries for comments to both internal and external stakeholders as appropriate. Distribute final summaries to all participants. Follow up with meeting participants on the resolution of action items from meetings.
Conduct ad hoc/special projects and analyses for GRADS Risk Management leadership.
Provide PV operations support as needed.
GRADS Global Risk Management AD Essential Functions
Adhere to Jazz templates and GxP guidelines for documentation and communications.
Ensures compliance with corporate and departmental policies, standard operating procedures, and timely completion of all assigned training.
Other duties as required to support GRADS Global Risk Management activities and objectives.
Participate in the development and maintenance of GRADS Global Risk Management activity workflow processes, department policies, work instructions, standard operating procedures, and training material when new and/or updated processes are introduced.
May serve as an individual contributor or a project manager for functional projects or workflows.
Mentor and develop team members.
Will have line management responsibility.
Participate in inspections and audits as identified, as well as an active role in maintaining a ways-of-working inspection ready state of operating.
Take responsibility for personal development and continuous improvement including keeping up to date with global pharmacovigilance and REMS current practices, industry standards, legislation, and guidelines.
Work collaboratively with cross-functional teams to evaluate the performance, identify bottlenecks, minimize regulatory risks, and recognize patterns of inefficiencies in current operational processes.
Collaborate effectively with functional teams including but not limited to: Quality Assurance, PV Legal, Pharmacovigilance, Medical Safety, Commercial, Channel Access, Medical Affairs, Procurement and Project Management.
Required Knowledge, Skills, and Abilities
Knowledge of current and emerging regulatory requirements and expectations including EMA GVP Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS.
Knowledge of pharmacovigilance activities and processes, with a preference for experience in more than one PV functional area.
Experience managing relationships with service providers or external business partners.
Excellent teamwork and interpersonal skills are required with ability to effectively collaborate with internal and external contacts, building strong sustainable relationships.
Excellent oral and written communication skills, demonstrating professional maturity (high emotional IQ), confidence and competence.
Ability to work effectively within a matrix organization to achieve desired outcomes.
Track record of effective decision-making.
Excellent conflict management/resolution skills.
Proven ability to demonstrate Jazz values and leadership competencies.
Ability to work across cultures, including in a virtual environment.
Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook).
Team Building, Motivating and Influencing Others without authority.
Promoting Innovation and Process Improvement Maintaining activities.
Negotiation skills, strong analytical skills. Must demonstrate accountability for delivery of results and have good problem-solving and decision-making skills.
Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines.
Required/Preferred Education and Licenses
BA/BS, MS/MA degree in health related or biological science related field, PharmD, RPh, or Nursing, strongly preferred.
A minimum of 6 years’ experience in pharmaceutical safety (Risk Management or PV) required with a minimum of 2 years of people management.
Channel Operations, Market Research and/or REMS Operations experience a plus.
PV Operations experience a plus.
People Manager Excellence
At Jazz, we believe that effective people leadership is essential to our success. Our people managers play a vital role in creating an environment where teams thrive, and individuals reach their full potential. Jazz invests in people managers to ensure they are equipped to drive performance, grow individuals and create belonging. As a result, Jazz people managers champion a culture of collaboration, inclusion, and belonging; ensuring that everyone feels heard and valued. They connect with their teams on a personal level, understanding their unique needs and motivations and providing personalized support to empower every team member to thrive.
#J-18808-Ljbffr