Associate Director Real World Evidence at Merck Healthcare Vietnam Ltd., Vietnam

Bangalore, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

31 Jan, 26

Salary

0.0

Posted On

02 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Real World Evidence, Epidemiology, Pharmacoepidemiology, Public Health, Biostatistics, Project Management, Regulatory Submissions, Data Analysis, Clinical Development, Cross-Functional Collaboration, Stakeholder Alignment, Mentoring, Process Improvement, Scientific Best Practices, Communication, Leadership

Industry

Pharmaceutical Manufacturing

Description

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Role: We seek an Associate Director Real World Evidence. Reporting to the Global Head of Real World Evidence Oncology, this role shapes RWE use in oncology to enhance decision-making and value creation. Key Responsibilities: As Associate Director Real Word Evidence: • Act as the functional product lead and subject matter expert (SME) for assigned product(s) • Lead RWE strategy for Integrated Evidence Plans (IEP) • Lead execution of RWE strategy for product(s) • Lead identification and selection of ﬁt-for-purpose RWD sources for a given research questions and contribute to the RWD strategy of the assigned product(s) therapeutic area. • Act as study lead for Non-Interventional Studies (NIS): • Act as a lead for crossfunctional analysis requests • Actively provide SME to product team meetings and other key internal strategic meetings (e.g., benefit risk action teams, clinical subteam meetings, publication strategy teams, ….) • Develop epidemiological sections for submission relevant documents, like RMPs, other safety documents (e.g., DSURs…), and other regulatory documents • Participate in and contribute to HA interactions (i.e. develop responses to regulatory agency requests or attend HA meetings) • Provide high quality input to critical review assessments, expert statements, publications, and study proposals from internal and external sources • Take ownership of and lead Business Plan initiatives, ensuring effective implementation and impact within the company • Show leadership, promote communication and set up adequate information flows • Ensure stakeholder alignment for projects and activities • Lead process improvement according to lean concepts aiming for simplication • Contribute to implementation of Scientific Best practices within the function and the company in general • Act as a mentor for less senior RWE scientists Who you are Masters’ or Doctoral degree, or PhD in (pharmaco)epidemiology, public health or biostatistics Comfortable in Business English 5-8 years of (pharmaco)epidemiological experience preferred in the Pharmaceutical/ Biotechnology Industry, academic setting, in CROs. Demonstrated experience in studies using RWD Strong methodological and design skills; epidemiology study designs/ analysis. Medical/ pharmacological/ pharmacovigilance knowledge would be a plus Experience of project management in studies life cycle, preferably exposed to a multi-cultural environment Comprehensive expertise in drug development, including knowledge of interfaces and interdependencies of clinical development with other functions Experience of global regulatory (and/ or payers) submissions and interactions Experience of the regulatory environment and of standards used in our field (GPP, GVP, ENCePP…) What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team!

Responsibilities

The Associate Director Real World Evidence will lead the RWE strategy for Integrated Evidence Plans and execute the RWE strategy for assigned products. This role also involves acting as a subject matter expert and study lead for Non-Interventional Studies, ensuring stakeholder alignment and promoting communication.