Real-world Evidence and Publication Manager
Il y a 6 mois
**Company Description**
**Job Description** Job purpose and objectives**:
You will be responsible for driving and executing our evidence generation plans within assigned therapeutic area
- and for keeping oversight of evidence generation activities and publications across these therapeutic domains. You will have the opportunity to contribute to impacting and shaping the real-world evidence generation strategy at country level.
Besides, your statistical and methodological expertise will be pivotal to unlock the value of particular (local/area) real-world evidence projects across all our therapeutic areas.
Within your assigned therapeutic areas, you will co-lead evidence gap prioritization work through close liaison with evidence and brand teams and you will collaborate closely with the medical affairs team and other functions such as market access and commercial to lead the development and implementation of innovative evidence generation solutions. You will identify and co-create scientifically robust and innovative, methodologically-sound research initiatives together with key members of brand teams and/or evidence teams. Further, you will be proactively involved in the local research ecosystem and any digital and data partnerships to close identified gaps. Besides, you will be responsible for driving and managing publications (incl. conference abstracts, posters, ) in a compliant manner.
You will be consulted for methodological questions (i.e. statistical input into research concepts/protocols, query for post-hoc analysis, statistical interpretation of performed data analyses, etc.).
In this role, you will strategically partner with numerous stakeholders inside and outside the affiliate and build expertise across several core business functions.
The function will be based in Belgium and will report to the Affiliate Real-World Evidence Lead.
**Tasks & Responsibilities**
- Manage local Real-World Evidence Research and Publications within **_your assigned Therapeutic Areas_**:
- Drive and oversee the development and execution of strategic evidence generation plans
- Pro-actively liaise with evidence teams and/or brand teams re. gap assessments and lead evidence teams in the Belgian Affiliate across the selected therapeutic areas, challenging gaps and ensuring alignment with business priorities
- Advise and co-create with key members of evidence teams and/or brand teams scientifically robust and innovative evidence generation initiatives to close the gaps
- Identify and evaluate vendors on an ongoing basis, and maintain oversight of existing vendors contracted to execute local research initiatives
- Drive key local evidence generation projects in close collaboration with local Medical Affairs Operations (Clinical Project Manager and Clinical Trial Assistant), or vendors, of relevant real-world evidence studies
- Understand the local research ecosystem, and be curious towards the research evolution incl. innovative methodologies, digital and real-world data partnerships
- Develop strong communication strategies in close collaboration with medical affairs employees to drive publications in cooperation with External Experts (managing publication plans)
- Drive and manage publications (incl. conference abstracts, posters, ) in a compliant manner
- Contribute to regional and global evidence solution initiatives such as evidence network meetings
- Partner with the Affiliate Real-World Evidence Lead and Medical Director re. medical affairs planning and monitoring, as appropriate
2. Provide **_methodology expertise_** in the light of Real-World Evidence projects:
- Provide statistical/methodology input into research concepts and protocols in collaboration with internal (e.g. medical affairs employees) and external stakeholders (e.g. vendors)
- Think on appropriate post-hoc analysis for RWE projects
- Aid with statistical interpretation of research results
- Lead, or co-lead (local/regional/global) RWE projects with a strong methodological compound
**Qualifications** Required skills and competencies**
- Master’s degree in a relevant (scientific) discipline or higher
- Knowledge of essential (bio)statistics relevant for pharmaceutical industry is strongly preferred (multivariable regression modelling, logistic models, cox-proportional hazards modelling, etc.); prior programming experience with statistical software is a big plus
- A first experience in pharmaceutical industry, CRO or academic research with demonstrated experience in a range of evidence generation methodologies is highly preferred
- Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
- Excellent written and spoken communication and presentation skills (English; and 1 of local languages French/Dutch preferred but not mandatory)
- Dynamic, innovative and strategic thinker as well as sound judgment, strong planning and organizational skills, and the ability to get things done
- Ability t
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