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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.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
Brief Description:
As a member of the REMS Strategy and Operations department, the Senior Manager of REMS Project Management will provide support for FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs. Role will support the Director level of the department in multiple department initiatives in the US. This role provides management and ongoing development and review of staging of REMS Document and related materials, FDA information requests, coordinating and managing related REMS team meetings for internal Jazz teams, external REMS administrator, or REMS vendors. Role will provide information of ongoing projects and initiatives to senior management as required. Support presentation development and delivery to senior leadership.
Essential Functions
• Project management for U.S. FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs at Jazz Pharmaceuticals.
• Develop and manage the ongoing internal REMS required team meetings, external REMS administrator and vendor meetings, provide and manage team meeting notes, timelines and follow-ups with key contributors, as required
• Stage all new and existing REMS documents and materials as necessary for new REMS program requirements, or modifications to current REMS programs, as requested
• Oversee development and/or modification of REMS stakeholder materials
• Upload and route all required REMS documents, materials and FDA Information Requests to internal Jazz stakeholders, as required
• Manage REMS contractor vendors, work orders, and department budgets; ensure all REMS vendor contracts and work orders are in good standing and in place prior to work commencing or continuing, and obtain necessary reviews and approvals from Jazz stakeholders.
• Support daily department functions required to meet business and regulatory requirements within team and cross-functional activities.
• Support daily function for support of multiple product responsibilities to meet REMS requirements.
Required Knowledge, Skills, and Abilities
• A minimum of 4-6 years of experience in the pharmaceutical industry, with 2-3 years' experience in REMS Development
• Proficient computer and MS application required
Required/Preferred Education and Licenses
• Bachelor's degree (or equivalent) in relevant field, required
Description of Physical Demands
• Occasional mobility within office environment.
• Routinely sitting for extended periods of time.
• Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
• Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
• Frequent computer uses at workstation.
• May move from one work location to another occasionally.
• Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
• Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US-BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $128,000-$168,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits
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.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
Brief Description:
As a member of the REMS Strategy and Operations department, the Senior Manager of REMS Project Management will provide support for FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs. Role will support the Director level of the department in multiple department initiatives in the US. This role provides management and ongoing development and review of staging of REMS Document and related materials, FDA information requests, coordinating and managing related REMS team meetings for internal Jazz teams, external REMS administrator, or REMS vendors. Role will provide information of ongoing projects and initiatives to senior management as required. Support presentation development and delivery to senior leadership.
Essential Functions
• Project management for U.S. FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs at Jazz Pharmaceuticals.
• Develop and manage the ongoing internal REMS required team meetings, external REMS administrator and vendor meetings, provide and manage team meeting notes, timelines and follow-ups with key contributors, as required
• Stage all new and existing REMS documents and materials as necessary for new REMS program requirements, or modifications to current REMS programs, as requested
• Oversee development and/or modification of REMS stakeholder materials
• Upload and route all required REMS documents, materials and FDA Information Requests to internal Jazz stakeholders, as required
• Manage REMS contractor vendors, work orders, and department budgets; ensure all REMS vendor contracts and work orders are in good standing and in place prior to work commencing or continuing, and obtain necessary reviews and approvals from Jazz stakeholders.
• Support daily department functions required to meet business and regulatory requirements within team and cross-functional activities.
• Support daily function for support of multiple product responsibilities to meet REMS requirements.
Required Knowledge, Skills, and Abilities
• A minimum of 4-6 years of experience in the pharmaceutical industry, with 2-3 years' experience in REMS Development
• Proficient computer and MS application required
Required/Preferred Education and Licenses
• Bachelor's degree (or equivalent) in relevant field, required
Description of Physical Demands
• Occasional mobility within office environment.
• Routinely sitting for extended periods of time.
• Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
• Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
• Frequent computer uses at workstation.
• May move from one work location to another occasionally.
• Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
• Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US-BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $128,000-$168,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits
