Medical Affairs Specialist/Manager

Job Description:

• Build trusted scientific partnerships with key external experts and medical societies to gather information on current and future therapeutic area issues and questions, and emerging medical and healthcare practices.
• Serve as the clinical liaison to provide medical insights, ensuring our products are designed with the highest standards of patient care in mind.
• Lead the Medical Compliance strategy execution in line with Medical Governance requirements, iNova standards and relevant local rules and regulations.
• Ensure compliance of Medical Affairs activities with iNova’s policies and procedures, and the appropriate regulatory and legal requirements for appropriate scientific/medical exchange and communication with customers.
• Execute a well differentiated Continuing Medical Education (CME) Plan aligned with both Marketing and Sales.
• Should ensure timely and compliant processing and approval of CME events, sponsorships and grants
• Prepare base modules for CMEs, review modules prepared by speakers and brief speakers for CMEs
• Ensure timely, accurate and compliant preparation and review of promotional and educational materials.
• As the local iNova Indonesia PV and Drug Safety Officer and work closely with the global patient safety risk management team – key role in managing the reporting and management of adverse events and adverse drug reaction in accordance with the company’s SOP and local regulatory requirements and also to oversee overall 

• local safety assessment, evaluation and risk management of products or product groups for iNova Indonesia.
• Involved in all local safety surveillance activities and communication and management of local vendor and agency where applicable.
• Participate as a member in regular meeting with the GPRM team.
• Act as a medical spokesperson for iNova in any external communications especially if it involves any particular products or issues regarding product safety and effectiveness.
• Perform regular and extensive literature reviews and develop presentations and aid in medical communications.
• Provide timely and accurate medical information responses to unsolicited queries from healthcare professionals (HCPs ) and consumers regarding our products
• Conduct internal and external disease and product trainings.
• Collaborate with different functions locally and within the region
  

Qualification:

• Hold MD degree with 2–3 years’ experience as Medical Affairs or as Medical Science Liaison as an advantage.
• Previous PV experience preferred.
• Familiarity with industry standards, practices, and regulations.
• Strong analytical and problem-solving skills, with the ability to make informed, evidence-based decisions.
• Ability to research scientific literature and write reports, papers.
• Understand the industry code of ethics and practice.
• Skilled in medical education and medical affairs.
• Working knowledge on anatomy and physiology, pathophysiology and pharmacology.
• Excellent verbal and written communication skills, with experience presenting to diverse stakeholders.
• Experience in research scientific literature, and write reports
• Effectiveness in building sustained partnerships and working with colleagues and partners.