Business Partnership Operations Leader in Global Regulatory Affairs and Drug Safety Alliance Management (Remote) Job at Jazz Pharmaceutical, Palo Alto, CA

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  • Jazz Pharmaceutical
  • Palo Alto, CA

Job Description

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 and follow @JazzPharma on Twitter.

Job Description

This Job Description provides a summary of the duties and/or characteristic of work performed and is not inclusive of every detail of the job for every individual assigned to the position. This description will be reviewed periodically and revised as duties and responsibilities change with business demands. Other duties not listed below may be assigned as needed.

Brief Description:

This role leads the team responsible for evaluation of new deals impacting the Global Regulatory Affairs and Drug Safety (GRADS) organization including, but not limited to Regulatory Affairs, Labeling, REMS, Regulatory Operations, CMC, Medical Safety including PV Operations EUQPPV Office as well as alliance management for existing and new partnerships within the GRADS space.

Essential Functions/Responsibilities
  • The incumbent manages the team responsible for evaluation of new business development partnerships and alliance management of existing partnerships.
  • Manage the strategy, negotiation, and provisions of the GRADS (inclusive of Regulatory Affairs, Labeling, REMS, Regulatory Operations, CMC, Medical Safety including PV Operations EUQPPV Office) components of the Master Commercial Agreements with external partners involving but not limited to product acquisitions, collaborations, distribution, co-marketing, co-promotion, joint ventures, and divestitures. Collaborates with the head of GRADS PV Licensing/Alliance Management to manage the Medical Safety, PV Operations and EU QPPV office components.
  • End to End responsibility for GRADS implementation and maintenance for all business development partnerships. Serve as the conduit for ongoing alliance management issues between GRADS functions and the partner.
  • Develop new ancillary regulatory agreements for complex deals that expand on development-related details not fully articulated within the master commercial agreement.
  • Represent Jazz in negotiations with external partners and lead the agreement activities that have GRADS organizational impact. Negotiates, on behalf of the individual functions, the right strategy with the partner to ensure global compliance for Jazz. This includes influence on the external parties as well as internal to Jazz-the executive level management, across divisions, and across countries/affiliates.
  • Interact closely with Legal, Business Development, and Corporate Alliance Management through the execution of strong processes for managing deals in the pre-execution space including due diligence, resource analysis, contractual provisions by deal type, and communications.
  • Upon execution of all BD deals, ensure that deals are implemented within all GRADS functional areas.
  • In collaboration with the leader of GRADS PV Alliance Management, create, design and maintain integrity of a Business Development Lifecycle Management system used for extraction of key fields from executed contracts and to be accessed for partner notification of signal detection, CCDS updates, aggregate report review and receipt.
  • Direct the resolution of highly complex business problems that have direct influence on the strategy or implementation for the GRADS Organization.
  • Apply business and management expertise to drive operational performance across the GRADS organization. Partner with GRADS Compliance to resolve any compliance or quality issues resulting from executed partnerships.
  • Provide leadership and direction through managers and individual contributors.
  • Present complex processes, anticipates potential objections, and persuade others to adopt a different point of view if appropriate. This includes external parties and internal to Jazz (senior level management, and across countries).
  • Serve as a key resource and expert for others in the company in interpreting, developing, and applying GRADS considerations in the licensing strategy. Demonstrates depth of expertise in licensing and broad knowledge of the functional areas within GRADS.

Required Knowledge, Skills, and Abilities
  • BS Degree preferably in Technical discipline (science, engineering) or Life Sciences (Biology, Chemistry, Nursing, Pharmacy) or related discipline.
  • At least 15 years in the pharmaceutical industry with at least 5 years focused on regulatory, PV or licensing roles.
  • At least 5 years as a people manager of individual contributors or other people managers.
  • Knowledge of the end to end drug/device/biologic development process.
  • Experience with Business Development and/or development strategy and process for Licensing deals preferred.
  • Ability to collaborate with multiple teams and effectively operate in a rapidly changing environment while being quality and compliance oriented.
  • Must have proven track record to be able to think critically, strategically, independently and problem solve.
  • Must have high level of motivation, drive, and demonstration of Jazz leadership values.
  • Excellent written and verbal communication skills and negotiation skills including ability to write clearly and concisely.
  • Top notch interpersonal skills in difficult situations.
  • Driver of change and innovation.
  • Ability to work seamlessly with all levels of personnel.
  • Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations.
  • Excellent Microsoft office application skills as well as, e-mail and online meeting tool skills.
  • Ability to accommodate 10% to 20% US and/or international travel.

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.

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 full and complete base pay range is:
$176,000.00 - $264,000.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

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:

Job Tags

Flexible hours,

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