MSD Malaysia
Job DescriptionWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of our products is realized. We engage and train internal employees to ensure that they thoroughly comprehend the science behind the medicine and review further unmet medical needs to bolster collaboration and further differentiate our portfolio.As the Country Medical Director (CMD) and Senior Medical Leader for our company in Israel, you will lead the Medical Affairs organization and serve as the primary country-level contact for Medical Affairs. In this role, you will develop and execute the Medical Affairs strategy for the country, build and sustain a high-performing, highly compliant Medical Affairs organization, manage our full portfolio and allocate resources to balance global and local priorities; represent the research arm of the company or Medical Affairs on the country Leadership Team and in cross-functional collaborations with other functions; communicate the country’s accomplishments, opportunities, and needs to regional and global stakeholders; and represent our company externally in activities requiring the leadership and expertise of the country’s Senior Medical Leader.**What You Will Do:****Leadership of the Medical Affairs Organization****People:*** Proactively manage and develop talent, whilst identifying new opportunities
vs. emerging needs by reallocating resources,
upskilling
the team and recruiting* Create an empowering, compliant, collaborative, and innovation-focused work environment* Build a culture of quality and compliance through training, oversight, and collaboration**Country Medical Affairs Plans (CMAPs):*** Strategically develop, execute, and deliver CMAPs, including tactical deliverables for each therapeutic area, such as post-licensure research, publication plans, investigator-initiated studies, and other knowledge transfer activities* Ensure alignment of the CMAPs with global strategy and adherence to all relevant regulations, Policies and Standard Operating Procedures (SOPs)* Manage the country-developed Protocol Concept Sheets (PCS), obtain regional and global approvals for new local data generation activities, and manages their execution**Medical Affairs Management:*** Provide oversight to the country medical information team, establish processes and systems to ensure that medical information requests (MIRs) from healthcare professionals are addressed in a timely manner and in alignment with the global scientific response documents and training materials* Manage approved operating administrative (e.g., salaries & travel) and life cycle management budget (e.g., advisory boards, local data generation, etc.)* Oversees all activities of local medical department employees* Oversees inspections and inspections audits, answering inquiries by health authorities, ethical committees, and internal auditors in conjunction with Regulatory, Pharmacovigilance (PV) and Global Clinical Trial Operations (GCTO)**Collaboration With Key Internal Stakeholders**You will represent Medical Affairs in cross-functional leadership teams and collaborations and advocate for the interests of the country
with regional and global colleagues**Country (or Cluster) Leadership Team*** Represents Medical Affairs and is the “medical voice” in the country
executive management team**Global Clinical Development (GCD), Global Clinical Trial Operations (GCTO), and Global Clinical Scientific Affairs (GCSA)*** Support GCTO when requested* Manage the submission and our roles in the conduct of investigator-initiated studies* Lead country review of Compassionate Use Requests and Pre-License Patient Access (PLPA) programs and facilitates Chief Medical Officer (CMO) approval of these requests**Center for Observational and Real-World Evidence (CORE), Market Access, Regulatory Affairs, HH, and Policy*** Interact with CORE, Market Access, and Global Medical Affairs experts to develop and manage observational, real-world effectiveness and epidemiologic studies* Collaborate with CORE, market access, regulatory and commercial colleagues by providing scientific expertise and managing the medical aspects of submissions for regulatory, reimbursement or tenders for our company’s entire portfolio of medicines and vaccines* Provide medical expertise to the commercial product teams, ensuring the scientific and medical value of our company’s products across all therapy areas**Engagement With Key External Stakeholders*** Serves as external interface with key stakeholders, insurers/government leaders, selected professional societies, medical-scientific institutions, and the broader scientific community to lead and execute the medical research and implementation strategy for our company’s innovative medicines, ensuring that the medical community is appropriately engaged with the information they need to support patient care needs (e.g., scientific advisory boards, scientific leader (SL) engagements, webinars, and presentations)* Collaborates with CORE, Market Access, and Commercial colleagues to engage payers, policymakers, and other decision makers in support of our company’s innovative portfolio of medicines and vaccines* Develops and/or fosters relationships with external stakeholders to ensure that robust local insights from health care providers (HCPs) and patients are gathered and integrated into local, regional, and/or global strategies, plans, and tactics, enabling the generation of data needed by payers, physicians, and patients to properly understand and value our innovative medicines and vaccines* Participates in outcomes research/health economics engagements with national payers, Health Technology Assessment (HTA) or regulatory agencies, in coordination with CORE, Market Access, and Commercial colleagues* Provides scientific subject matter expertise for media relations and public affairs to country Communications, Corporate/External Affairs, and Public Relations teams and serves as official spokesperson for scientific matters**What You Will Need:*** MD or equivalent degree* Global biopharmaceutical industry experience in clinical development and/or medical affairs with demonstrated track record of success* People-management experience* Demonstrated organizational skills, including ability to set goals and align priorities#LIDNP**Required Skills:**Advisory Board Development, Advisory Board Development, Biopharmaceutical Industry, Clinical Development, Clinical Trials, Cross-Cultural Awareness, Cross-Functional Teamwork, Data Analysis, Global Strategy, Healthcare Education, Healthcare Management, Health Economics, Health Outcomes Research, Health Technology Assessment (HTA), Management Process, Market Access, Market Landscape Analysis, Medical Affairs, Medical Care, Medical Knowledge, Medical Marketing Strategy, Medical Research, Outcomes Research, People Leadership, Pharmaceutical Medical Affairs {+ 3 more}**Preferred Skills:**Current Employees applyCurrent Contingent Workers apply**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event #J-18808-Ljbffr
vs. emerging needs by reallocating resources,
upskilling
the team and recruiting* Create an empowering, compliant, collaborative, and innovation-focused work environment* Build a culture of quality and compliance through training, oversight, and collaboration**Country Medical Affairs Plans (CMAPs):*** Strategically develop, execute, and deliver CMAPs, including tactical deliverables for each therapeutic area, such as post-licensure research, publication plans, investigator-initiated studies, and other knowledge transfer activities* Ensure alignment of the CMAPs with global strategy and adherence to all relevant regulations, Policies and Standard Operating Procedures (SOPs)* Manage the country-developed Protocol Concept Sheets (PCS), obtain regional and global approvals for new local data generation activities, and manages their execution**Medical Affairs Management:*** Provide oversight to the country medical information team, establish processes and systems to ensure that medical information requests (MIRs) from healthcare professionals are addressed in a timely manner and in alignment with the global scientific response documents and training materials* Manage approved operating administrative (e.g., salaries & travel) and life cycle management budget (e.g., advisory boards, local data generation, etc.)* Oversees all activities of local medical department employees* Oversees inspections and inspections audits, answering inquiries by health authorities, ethical committees, and internal auditors in conjunction with Regulatory, Pharmacovigilance (PV) and Global Clinical Trial Operations (GCTO)**Collaboration With Key Internal Stakeholders**You will represent Medical Affairs in cross-functional leadership teams and collaborations and advocate for the interests of the country
with regional and global colleagues**Country (or Cluster) Leadership Team*** Represents Medical Affairs and is the “medical voice” in the country
executive management team**Global Clinical Development (GCD), Global Clinical Trial Operations (GCTO), and Global Clinical Scientific Affairs (GCSA)*** Support GCTO when requested* Manage the submission and our roles in the conduct of investigator-initiated studies* Lead country review of Compassionate Use Requests and Pre-License Patient Access (PLPA) programs and facilitates Chief Medical Officer (CMO) approval of these requests**Center for Observational and Real-World Evidence (CORE), Market Access, Regulatory Affairs, HH, and Policy*** Interact with CORE, Market Access, and Global Medical Affairs experts to develop and manage observational, real-world effectiveness and epidemiologic studies* Collaborate with CORE, market access, regulatory and commercial colleagues by providing scientific expertise and managing the medical aspects of submissions for regulatory, reimbursement or tenders for our company’s entire portfolio of medicines and vaccines* Provide medical expertise to the commercial product teams, ensuring the scientific and medical value of our company’s products across all therapy areas**Engagement With Key External Stakeholders*** Serves as external interface with key stakeholders, insurers/government leaders, selected professional societies, medical-scientific institutions, and the broader scientific community to lead and execute the medical research and implementation strategy for our company’s innovative medicines, ensuring that the medical community is appropriately engaged with the information they need to support patient care needs (e.g., scientific advisory boards, scientific leader (SL) engagements, webinars, and presentations)* Collaborates with CORE, Market Access, and Commercial colleagues to engage payers, policymakers, and other decision makers in support of our company’s innovative portfolio of medicines and vaccines* Develops and/or fosters relationships with external stakeholders to ensure that robust local insights from health care providers (HCPs) and patients are gathered and integrated into local, regional, and/or global strategies, plans, and tactics, enabling the generation of data needed by payers, physicians, and patients to properly understand and value our innovative medicines and vaccines* Participates in outcomes research/health economics engagements with national payers, Health Technology Assessment (HTA) or regulatory agencies, in coordination with CORE, Market Access, and Commercial colleagues* Provides scientific subject matter expertise for media relations and public affairs to country Communications, Corporate/External Affairs, and Public Relations teams and serves as official spokesperson for scientific matters**What You Will Need:*** MD or equivalent degree* Global biopharmaceutical industry experience in clinical development and/or medical affairs with demonstrated track record of success* People-management experience* Demonstrated organizational skills, including ability to set goals and align priorities#LIDNP**Required Skills:**Advisory Board Development, Advisory Board Development, Biopharmaceutical Industry, Clinical Development, Clinical Trials, Cross-Cultural Awareness, Cross-Functional Teamwork, Data Analysis, Global Strategy, Healthcare Education, Healthcare Management, Health Economics, Health Outcomes Research, Health Technology Assessment (HTA), Management Process, Market Access, Market Landscape Analysis, Medical Affairs, Medical Care, Medical Knowledge, Medical Marketing Strategy, Medical Research, Outcomes Research, People Leadership, Pharmaceutical Medical Affairs {+ 3 more}**Preferred Skills:**Current Employees applyCurrent Contingent Workers apply**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event #J-18808-Ljbffr