Position Summary:

The Regional Medical Affairs Manager leads the medical affairs and clinical operations for designated therapy areas (TAs). Provides evidence based medical support, including but not limited to new product opportunity assessment, acquisition due diligence, clinical trial planning and strategy, promotional material / publication planning and strategy and mentoring other MSLs and medical advisors from region and the countries belonging to same TA.

KEY Responsibilities:

Medical Affairs

• Develop and lead medico marketing strategy in collaboration with commercial and other stakeholders
• Lead the insight analysis and support the data generation and publication plan to address the knowledge /data gaps for the TAs
• Responsible for approval of all product promotional material, in compliance with corporate standards government/industry regulations and to ensure the highest degree of medical and ethical standards.
• Act as a medical contact for Key Opinion Leaders (KOLs) and external Medical Experts
• Support building of strong regional advisory boards and expert panels for key therapeutic areas
• Provide strategic medical input into core brand strategies and support medical marketing activities such as publications, promotional materials and product launches
• Medical Information Enquiries for assigned TA
• Monitor competitive and regulatory landscape (e.g. guidance from FDA, competitive clinical studies, etc.)
• Other activities, as assigned, to support Medical Affairs

Phase IV & Real World Studies (excluding Phase 1-3)

• Provide scientific and medical advice for all Phase IV studies, investigator initiated studies & studies arising as a post-approval commitment/requirement
• Provide scientific expertise into study concepts, participate in development of study synopsis, protocols, and other study documents; and liaise with affiliates and investigators
• Lead the executing of studies in accordance with the SOPs
• Other activities, as assigned, to support Medical Affairs

Business Development

• Evaluate and provide high quality medical assessment for the Business development opportunities for corporate. regional & local assets
• Proactive provide insights to commercial and BD team on the potential assets
• Continue to improve efficiency and streamline the process of medical evaluations

KEY REQUIREMENTS:

• At least 5- 8 years' experience in Medical Affairs in Device/Pharma companies
• Proven experience in Clinical Research or Medical Affairs role, preferable both
• High attention to details and accuracy, database experience preferred
• Strong organizational skills and ability to work with minimal supervision
• Excellent communication skills
• Bachelor's degree in Biostatistics, Life Science or equivalent, MD or PhD preferred
• Ability to Travel up to 25%
• Commercial awareness
• Unquestionable integrity and positive attitude
• Great at building relationships, particularly with KOLs