Janssen Global Services is currently recruiting for an Associate Director Market Access Operations & Excellence, within the Global Commercial Strategy Organization (GCSO), to be located in Raritan, NJ or Beerse, Belgium. This role will be in the HUB (Global Market Access & Commercial Strategy Operations) team.
Janssen Global Services, L.L.C. (JGS) is a legal corporate entity encompassing a unique group of departments/organizations/teams that provide leadership across business-critical areas for Janssen, the pharmaceutical companies of Johnson & Johnson.
The Associate Director Market Access Operations & Excellence will be part of the Health Technology assessment (HTA) & Decision Science (DS) team. This team is responsible to support Janssen’s activities to meet the needs of increasingly evidence-driven and cost-conscious HTA agencies and payers around the world and to inform internal decision making by (1) providing subject matter expertise on HTA requirements and championing access-led development and evidence generation, (2) by enabling data-driven internal decision making and (3) by ensuring organizational learning and knowledge through consistent application of processes & best practices including preparation for European level Joint Clinical Assessments across Therapeutic Areas.
Main deliverables for the role
· Provide operational support and leadership to drive global operational tasks to co-develop and implement an aligned, coordinated, strategic and integrated global & regional approach to the European Union (EU) Health Technology Assessment (HTA) Joint Clinical Assessment (JCA) process end-to-end and ensure flawless operational execution & excellence across Therapy Areas; closely collaborate and partner with EMEA Operations & Excellence Lead
· Process management: Roadmap, timelines and governance/sign-off
· Operational guidance
· Workflow management & operational efficiency
· Submission management
· Document management
· Stakeholder engagement & management
Job responsibilities :
· The Ass Director Market Access Operations & Excellence will be part of the cross-functional cross-regional Joint Clinical Assessment (JCA) core team and will be responsible for providing operational support and leadership to drive global operational tasks to co-develop and implement an aligned, coordinated, strategic and integrated global & regional approach to the European Union (EU) Health Technology Assessment (HTA) Joint Clinical Assessment (JCA) process end-to-end and ensure flawless operational execution & excellence across Therapy Areas; this will be done in close collaboration and partnership with the respective EMEA Operations & Excellence Lead
· Detailed responsibilities include:
- Process management & process oversight:
- Development of a global roadmap with clear milestones, timelines and a governance/sign-off process; identification of key interdependencies with other relevant processes (such as Joint Scientific Consultations, the EMA marketing authorization process; local HTA submission processes) and internal stage gates
- Development of internal global Process Guidance/ Work Instructions’ document incl. roles & responsibilities
- Implementation and oversight of end-to-end process; identification, flagging and removal of potential roadblocks.
- Support key related activities such as internal horizon scanning.
o Coordinated, timely and efficient submission management and management of post-submission data & information requests and fact checks.
- Workflow management:
- Meeting coordination and set-up, agendas, minutes, timely follow through on action items.
- Drive operational efficiency.
- Engage and manage cross-regional and –functional stakeholders and ensure optimal flow of communication to and from internal and external stakeholders.
- Establish efficient and compliant document review and management system; leverage learnings from other functions such as Global Regulatory Affairs
Critical attributes for the role :
The Associate Director will closely partner with different functions across the organization such as the Global Compound Market Access leaders, other relevant key members of the R&D-led Compound Development Teams (Clinical Leaders, Global Regulatory Leads, Compound Development Team Leaders), the EMEA Operations & Excellence Lead, Regional and Operating Company Market Access Leads and relevant functions in the Market Access Center of Excellence as required. A global mindset, ability to collaborate with diverse groups in a complex matrix, commitment to excellence, attention to detail, can-do attitude, strategic thinking, sense of urgency and accountability are key attributes for success for the role.
· A university degree is required. A master’s degree or PhD is an additional asset.
· Strong Process Management & Operations skills / experience; 6+ years of directly related experience is required (demonstrable track record of managing complex processes).
· Experience in Market Access & specifically HTA (from industry, HTA agency or consulting).
· Working knowledge of the reimbursement requirements, key decision drivers for HTA, and HTA review processes for key international markets is a requirement.
· Basic understanding of regulatory authority processes and drug development is required.
· Ability to proactively drive process and operations, including stakeholder communications.
· Ability to plan and tightly manage the scope of multiple projects while balancing multiple stakeholders as necessary.
· Ability to develop operations guidance / work instructions.
· Knowledge of document review and management systems.
· Strong oral and written communication skills with intellectual curiosity and the ability to understand, summarize and communicate complex material. Must be able to demonstrate collaboration and teaming skills while working within cross-functional international teams.
· Pharmaceutical Industry Experience: Experience with applied work in one or more of the following therapeutic areas: Oncology, Neuroscience, Immunology, Pulmonary Hypertension, Cardiovascular & Metabolism, and Ophthalmology is preferred.
The position is based in Beerse, Belgium or Raritan, NJ, and will require domestic and international travel as needed.