Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.comJob Function: Product SafetyJob Sub Function: PharmacovigilanceJob Category: Scientific/TechnologyAll Job Posting Locations: Burnaby, British Columbia, Canada, Markham, Ontario, Canada, Oakville, Ontario, Canada, Toronto, Ontario, Canada:Manager, Local Medical Safety, Vendor PartnershipsAbout Innovative MedicineOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicineWe are searching for the best talent for a Manager, Local Medical Safety (LMS) Vendor Partnerships to be located in Portugal, United Kingdom, Turkey, Spain, Serbia, Romania, Bulgaria, South Korea, Philippines, India, Costa Rica, Brazil, or Canada. This position may require up to 5% travel.Per our J&J Flex Policy, the expectation for this position is to work in office 3-4 days per week and work from home 1-2 days per week.Purpose:You will be responsible for establishing and furthering the relationship between Local Medical Safety teams and assigned vendors (global, regional, local) to ensure oversight to Local Medical Safety contracted services (e.g., individual case safety report handling, including translation, literature review, etc.), services-related or systems-related issue identification and resolution, establishment, modification and termination of Key Performance Indicators, invoice review, and other activities as needed. The Manager, LMS Vendor Partnerships is the primary point of contact among Local Medical Safety, Vendor, and GMO Strategic Procurement Office and GMS Business Management and Metrics. This person will actively participate in all vendor oversight, operational, and governance meetings. The person in this role, in partnership with Local Medical Safety Process, Systems, Oversight, and Regional Liaisons, will ensure solutions are applied globally and issues are assessed for global Local Medical Safety implications and solutions.You will be responsible for:

• Vendor Relationship

• Is a subject matter expert on the contracted services from the vendor, the contract, and Local Medical Safety viewpoints.
• Work to a collective understanding across Local Medical Safety and Vendor leadership, leading issue definition, solution identification, alignment, and implementation.
• Establish, modify, and terminate key performance indicators, as appropriate, to meet Local Medical Safety needs/based on Local Medical Safety leadership feedback.
• Actively participates in all GMO/Vendor oversight meetings for oversight of all metrics and topics presented, and alignment of Local Medical Safety vendor services with GMSO (Global Medical Safety Operations) vendor services, as appropriate.

• Vendor Finance Oversight

• Review invoices for approval, seek accrual figures for quarterly updates. In partnership with GMS Business Management and Metrics, identifies any needed supplemental information from the vendor to perform invoice reviews. Seek information/clarification from Vendor for any questions about invoices.

• Outsourcing Opportunity Maximization

• Using a global view, identify opportunities to align vendor support across all countries/clusters/regions, proactively maintain this vigilance as Local Medical Safety processes and global safety systems change.
• Partners with Local Medical Safety leadership to identify broader service opportunities, develops business case and leads implementation, including resource description, training development, new/revised KPI (Key Performance Indicator (KPI)) and contract changes when needed, as examples.
• Maintains oversight of all outsourced activities (managed across Local Medical Safety or at the Local Safety Unit). Develops material to provide this oversight/visibility to Operations Leadership and Local Medical Safety Leadership Team.
• Advises and facilitates vendor support for short term projects (e.g., bolus management).
• Ensures bolus cost estimations include Vendor costs across the project.

• Compliance Oversight

• Should an audit or self-identified quality issue arise, the Vendor Lead will provide Local Medical Safety Subject Matter Expertise into any investigation and will review any proposed correction/corrective action or preventative action prior to finalization. This may require consultation with Local Medical Safety Systems, Process, Oversight and/or LMS Operations Regional leads.

• Business Continuity

• The vendor lead will review and shape the vendor business continuity plan and approve that it meets J&J Innovative Medicine requirements.
• When Local Medical Safety business continuity needs develop, the Manager LSU Vendor Partnerships will seek Vendor support/solutions and/or alignment with the new needs.

• GMSO Vendor Strategy and Mechanisms Alignment

• Work closely with GMSO to leverage systems/procedures/metrics/data developed for GMSO oversight of similar vendors, when applicable. Make necessary modifications or develop new as appropriate based on evaluation with a goal to minimize associated effort on both the vendor and Local Medical Safety.

Qualifications / Requirements:

• A minimum of a Bachelors Degree (or equivalent) is required
• Minimum of 6 years of experience in the pharmaceutical industry in relevant function including but not limited to safety, medical affairs, regulatory affairs, or clinical.
• Proven ability to organize workflow activities and manage multiple critical issues.
• Awareness of, and familiarity with, J&J systems, procedures, and requirements for LSU pharmacovigilance activities (e.g., literature review, aggregate report creation/submission, translation support, etc.)
• Computer literate with knowledge of relevant IT safety systems.
• Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers.
• Ability to establish and maintain open relationships within the organization and with vendors.
• Fluency in English language is required.
• Experience working with vendors.

Preferred:

• Experience with managing vendor work and financial oversight, vendor agreement review, vendor KPIs and issue management.
• Experience working for a vendor providing services to a pharmaceutical company.
• Knowledge of Global, Regional and Local Procedural Documents related to provided Local Medical Safety vendor services. Pharmacovigilance adverse event report handling, especially mechanisms of intake and handling including systems, processes, and compliance oversight needs.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):Canada - Requisition Number: This Requisition, R- R-005960Brazil, Costa Rica - Requisition Number: R-005851Philippines, South Korea, Bulgaria, Portugal, Romania, Serbia, Spain, Turkey, United Kingdom: R-004233Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.#LI-Hybrid