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Medical Epidemiology Manager - Janssen

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Would you like to work within RWE and collaborate with the world for the health of everyone in it?

Your new company

Janssen are now looking for a medical epidemiology manager (Medical Affairs) in the operating company/Nordic cluster to design, manage and communicate robust therapy area evidence that can be used to shape local practice. This is a broad scope Medical Affairs and Market Access role that has critical strategic importance and business impact. The position encompasses substantial internal (operating company, regional/EMEA, global) and external relationships.

Your new role
 

Key Responsibilities

LOCAL ROLE

  • Proactively develop and deliver both country/cluster integrated evidence generation (IEGP) strategic objectives and plans, in alignment with patient needs, business priorities and Janssen's 2020 strategy to be a transformational medical innovator.
  • Defining and deploying the strategy for generating robust real world evidence (RWE) from local real world data (RWD) sources in Janssen Nordic therapy area(s).
  • Provide leadership to the Janssen Nordic organization in terms of local RWE utilization and development.
  • Providing internal consultancy in observational and outcomes research to the various internal stakeholders involved in the local RWE projects (MAF and HEMAR Department), while helping team to clarify key research questions.
  • Leveraging external stakeholders partnerships in the field of RWE
  • Managing vendors in the field of RWE (epidemiologists, statisticians, data scientists, medical writers)
  • Providing internal and external training in RWE
  • Collaborate with the CVTs in the development and execution of the RWE deliverables integrated in the Integrated Evidence Generation Plan (IEGP).
  • Provide support in the study design, interpretation and communication of results, of the observational research developed in Janssen Nordics.
  • Collaborate with the MAF Department to ensure the development of clinical observational studies.
  • Collaborate with HEMAR Department to ensure outcomes research to leverage P&R and Market Access.
  • Leverage the rolling out of innovative access schemes that require RW data collection or RWE generation.
  • Effectively represent the RWE function on local, international, multidisciplinary cross-functional teams and initiatives.
  • Build / maintain strong collaborative relationships with internal and external stakeholders in the RWE field.
  • Successfully present and defend RWE strategies to internal and external audiences.
  • Coordinate the identification, assessment and management of external data sources.

EMEA/GLOBAL ROLE
  • Plays a major role in shaping the Janssen EMEA RWE strategy.
  • Active member of the EMEA and MSM RWE networks.
  • Through collaboration with EMEA, Global, and local cross-functional teams, ensure that the country specific evidence needs are considered in the development of product integrated evidence generation plans; ensure involvement as early as possible to ensure early input to maximize potential of getting market authorization and patient access.
  • Ensure methodologically robust evidence is generated locally and in the region by providing protocol and analysis plan input.
  • Promote awareness of Nordic data and how they can be uniquely positioned to answer compound development team questions at all stages of product lifecycle development.

BUSINESS REQUIREMENTS
  • Proactively anticipate trends and pursue innovative solutions based on real world evidence and outcome data that demonstrates to key internal and external stakeholders the value of products in addressing healthcare issues.
  • Demonstrate and communicate the value of our compounds by generating evidence to support access and reimbursement with national and regional payers in the country/cluster.
  • Demonstrate strategic insight and foresight to create evidence generation projects that differentiate our products for payers and HCPs.
  • Focus on creating and generating compelling and high quality evidence that supports HTA and access discussions, and supports local HCPs to understand how their treatment practices impact various patients’ outcomes.
  • Lead the development of IEGP, working closely with the CVTs to ensure consistent and optimal approaches to evidence generation needs.

COMPLIANCE AND RISK MANAGEMENT
  • Complies with designated SOP’s and mandatory training for the role
  • Complete annual Adverse Event and Quality Complaint Reporting Awareness training and HCC/FCPA Awareness training
  • Report Adverse Events and Quality complaints in a timely way according to current guidelines/SOP
  • Acts in accordance with Johnson & Johnson HCC requirements in interactions with Healthcare Professionals and Government Officials
  • If commissioning contractors or third party organizations, perform Due Diligence where applicable, put compliant contracts in place and provide training, ensuring these individuals also act in accordance with Johnson & Johnson HCC requirements when interacting with Healthcare Professionals or Government Officials and ensure reporting of adverse events and quality complaints resulting from such collaborations (as above).
  • Complies with standards for good epidemiological practice

LEADERSHIP REQUIREMENTS   
        INFLUENCE ROBUST DEVELOPMENT OF NORDIC REAL WORLD EVIDENCE FROM LOCAL                         PRACTICE DATA
  • Work effectively with global and regional partners to maximize the impact of clinical studies and evidence generation strategies.
  • Engage in external discussions to shape the local ecosystem to Janssen therapy areas.
  • Partner with internal functions to build Janssen policy positions and communication tools to support conversations in RWE.
  • Work collaboratively to deliver high quality, aligned IEGPs.

        CAST A VISION FOR RWE DEVELOPMENT AND UTILIZATION
  • Create a clear vision for generating robust evidence and define a strategy for alignment in the Operating company in line with EMEA and global strategy, environment challenges and business priorities.
  • Translate the strategy into tangible and impactful evidence, delivering impactful evidence generation in the country/cluster.


What you'll need to succeed

  • Degree in a relevant scientific (life sciences) discipline.
  • Graduate degree (Masters or Doctorate) in a relevant RWE field such as epidemiology, health economics, medicine and health services research, and/or public health.
  • Knowledge of RWE methodologies, RWE sources and project implementation.
  • Knowledge of drug development, clinical trial management and clinical practice.
  • Familiar with health technological assessment methodologies and trends in public sector.
  • Proven capacity to work through complexity, difficulty, and adverse situations with agility adaptability and resilience.
  • Proven ability to work effectively in a complex and diverse organization, able to successfully influence and network in a matrix environment.
  • Proven experience in all phases of evidence generation, including result dissemination and communications.


What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your resume and personal letter in one document (word-format) as soon as possible. Interviews are on an ongoing basis. If you have questions, please contact Senior Recruitment Consultant Kristina Edholm on +46 (0)704 50 60 14. I Do look forward to receive your application!


Sammanfattning

Jobbtyp:
Rekrytering
Industri
Vetenskap & forskning/utveckling
Ort
Solna/Sundbyberg
Specialisering
Life Sciences
Ref:
896835
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Tala med Kristina Edholm, specialistkonsulten som hanterar denna position, i Stockholm

Hays, Sturegallerian, Stureplan 4C, Stockholm, Stockholm, 114 35

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