Publication & RWE health manager
Il y a 3 jours
Fresnes, Ile-de-France
4810 Consulting
Temps plein
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Gratuit avec email ou Google
4810 Consulting is looking for an publication manager combine with RWE manager in epidemiologic & Hypertension & Dyslipidemia care
ROLE PURPOSE
The Evidence Generation Manager will oversee the global management of multiple clinical studies, including prospective Phase IV, epidemiological, and retrospective studies, as well as Real World Evidence (RWE) initiatives.
The role also involves contributing to the design of new projects aligned with Lab client’s portfolio strategy and ensuring the effective dissemination of key findings.
This position operates at the intersection of medical strategy, real-world evidence, clinical development, and stakeholder engagement, with the objective of delivering timely, high-quality evidences that supports patient outcomes, informs guideline positioning, and strengthens product differentiation.
It requires solid expertise in both global and local study management, including the oversight of international Clinical Research Organizations (CROs), central medical review processes, and statistical data interpretation.
The role demands a high level of autonomy, along with strong interpersonal and communication skills to operate effectively within a multicultural environment (English proficiency is essential).
WHY JOIN THIS ROLE
High-impact role shaping future evidence in Hypertension & Dyslipidemia care
Opportunity to innovate (RWE, AI, in-silico trials)
Direct influence on practice, and patient outcomes
Strong visibility across global and affiliate leadership
KEY RESPONSIBILITIES
1.
Publications and scientific dissemination 2. Evidence Generation Strategy
· Develop and implement a comprehensive evidence generation plan aligned with medical strategies.
· Identify key evidence gaps across the patient journey.
· Prioritize studies supporting clinical differentiation, access, and guideline inclusion.
· Integrate clinical trials, RWE, and in-silico models, and Health Economics and Outcomes Research approaches. 3. Study Design & Execution
· Lead the design and execution of real-world studies (prospective/retrospective), pragmatic and hybrid trials, and innovative approaches (e.g. in-silico trials, digital twins, AI-based modelling)
· Manage international projects end-to-end, including global CRO oversight (data management, biostatistics), stakeholder coordination, and study documentation (protocols, ICFs)
· Oversee central medical review, data quality, and Trial Master Files
· Contribute to medical writing and the review/validation of study outputs (CSR, abstracts, publications, presentations)
· Support global and local teams, including subcontractor selection and local study management from start-up to close-out
· Review and validate CRFs, statistical analysis plans and reports; interpret results and identify additional analyses
· Ensure scientific rigor, feasibility, and full compliance across all activities, in alignment with regulatory requirements, ethical standards, and internal SOPs and governance processes. 4. Scientific Leadership
· Act as the internal expert on evidence generation methodologies
· Translate scientific insights into clear medical narratives
· Support development of: o Publications o Scientific communications o Congress strategies 5. External Engagement
· Build and maintain relationships with: o Therapeutic Area Experts (TAEs) o Academic institutions o Research networks
· Co-create studies with investigators and ensure high scientific credibility 6. Cross-functional Collaboration
· Partner with Global: o Medical Affairs (local, regional and global) o Global Product Strategy (Marketing, Value Access and Pricing) o Research & Development (TA, Global Safety, Regulatory…) o World Operations
· Ensure alignment between evidence generation and brand strategy QUALIFICATIONS & EXPERIENCE Education Advanced degree in life sciences (MD, PharmD, PhD) Additional training in clinical development is a plus Experience Medical affairs, clinical development, or evidence generation Cardiovascular disease area Proven track record in: Designing and delivering RWE or clinical studies Publications and scientific dissemination Experience in hypertension and/or dyslipidemia strongly preferred CORE COMPETENCIES publication trasnverse management Strong knowledge of regulatory, ethical, and compliance requirements for clinical research Solid project management and organizational skills Ability to collaborate effectively across global and local teams Experience in hypertension and dyslipidemia is an asset Deep understanding of: RWE methodologies Clinical trial design Epidemiology / biostatistics (working knowledge) Ability to translate science into impactful insights Excellent stakeholder engagement and influencing skills Innovation mindset (digital health, AI)
· Excellent communication skills.
· Excellent command of the English language, both in written and oral communication.
· Strong organizational skills. Soft Skills Proactive, curious, and solution-oriented mindset Strong communication and interpersonal skills Ability to work both independently and within cross-functional teams Languages English proficiency is essential
- French is a plus.
KEY RESPONSIBILITIES
1.
Publications and scientific dissemination 2. Evidence Generation Strategy
· Develop and implement a comprehensive evidence generation plan aligned with medical strategies.
· Identify key evidence gaps across the patient journey.
· Prioritize studies supporting clinical differentiation, access, and guideline inclusion.
· Integrate clinical trials, RWE, and in-silico models, and Health Economics and Outcomes Research approaches. 3. Study Design & Execution
· Lead the design and execution of real-world studies (prospective/retrospective), pragmatic and hybrid trials, and innovative approaches (e.g. in-silico trials, digital twins, AI-based modelling)
· Manage international projects end-to-end, including global CRO oversight (data management, biostatistics), stakeholder coordination, and study documentation (protocols, ICFs)
· Oversee central medical review, data quality, and Trial Master Files
· Contribute to medical writing and the review/validation of study outputs (CSR, abstracts, publications, presentations)
· Support global and local teams, including subcontractor selection and local study management from start-up to close-out
· Review and validate CRFs, statistical analysis plans and reports; interpret results and identify additional analyses
· Ensure scientific rigor, feasibility, and full compliance across all activities, in alignment with regulatory requirements, ethical standards, and internal SOPs and governance processes. 4. Scientific Leadership
· Act as the internal expert on evidence generation methodologies
· Translate scientific insights into clear medical narratives
· Support development of: o Publications o Scientific communications o Congress strategies 5. External Engagement
· Build and maintain relationships with: o Therapeutic Area Experts (TAEs) o Academic institutions o Research networks
· Co-create studies with investigators and ensure high scientific credibility 6. Cross-functional Collaboration
· Partner with Global: o Medical Affairs (local, regional and global) o Global Product Strategy (Marketing, Value Access and Pricing) o Research & Development (TA, Global Safety, Regulatory…) o World Operations
· Ensure alignment between evidence generation and brand strategy QUALIFICATIONS & EXPERIENCE Education Advanced degree in life sciences (MD, PharmD, PhD) Additional training in clinical development is a plus Experience Medical affairs, clinical development, or evidence generation Cardiovascular disease area Proven track record in: Designing and delivering RWE or clinical studies Publications and scientific dissemination Experience in hypertension and/or dyslipidemia strongly preferred CORE COMPETENCIES publication trasnverse management Strong knowledge of regulatory, ethical, and compliance requirements for clinical research Solid project management and organizational skills Ability to collaborate effectively across global and local teams Experience in hypertension and dyslipidemia is an asset Deep understanding of: RWE methodologies Clinical trial design Epidemiology / biostatistics (working knowledge) Ability to translate science into impactful insights Excellent stakeholder engagement and influencing skills Innovation mindset (digital health, AI)
· Excellent communication skills.
· Excellent command of the English language, both in written and oral communication.
· Strong organizational skills. Soft Skills Proactive, curious, and solution-oriented mindset Strong communication and interpersonal skills Ability to work both independently and within cross-functional teams Languages English proficiency is essential
- French is a plus.