POSITION SUMMARY:
Being part of the Regional Medical Affairs Team, this role will directly report to the Associate Regional Medical Director, based in Singapore. This role will be act as the Therapeutic Area Regional Medical Lead (MPH and MCH portfolio), be responsible for medical governance, RMA audits, SOP updates, medical compliance, digital initiatives and clinical operations matters.
KEY RESPONSIBILITIES:
Medical Affairs: Provide medical and scientific support for the therapeutic areas
- The regional therapeutic expert for the assigned therapy areas (TAs), working in collaboration with the regional marketing teams.
- Provide strategic medical input into core brand strategies and support medical marketing activities such as promotional material, business development assessments, product launches, omni channel engagement, brand planning etc.
- The regional medical point of contact for the TAs for the regional and local medical and marketing teams for providing directions and support on medical action items, including but not limited to KOL engagements, insight seeking, advisory boards, Medical led meetings and initiatives, patient centricity, medical omni-channel communications etc.
- Conduct regional scientific trainings on the disease and products
- Lead life cycle management and data generation activities for the regional/corporate brands
- Support building of strong regional advocates and expert panels and speakers for the brands.
- Maintain knowledge of relevant regulations and guidelines and disseminates same to clinical project teams
- Research and prepare training on therapeutic areas and indications of relevance and maintains an awareness of trends and changes of importance in management of those indications
- Initiates and maintains interactions with key opinion leaders and investigators in therapeutic areas of interest. Create and implement KOL mapping and engagement plan.
- Attend and act as advisor to relevant clinical development projects or Menarini Clinical meetings
- Conduct medical assessment for the respective brands for business development opportunities
Medical Governance, RMA audits, SOP updates, Medical compliance, digital initiatives
Clinical Operations :
- Leads all stages of the clinical trial development process including: feasibility assessments; protocol design; CRF design; investigational site selection; generation of clinical study reports and the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
- Regional medical lead for CRO management
- Takes responsibility for and initiates the medical review of all clinical study documents and reports
- Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts
- Proactively identifies and resolves issues, and participates in process improvement initiatives as required
- Reviews and approves invoices from study vendors, investigators, consultants, etc. and planning of the clinical study budgets.
- Oversee medical aspects of the risk management and risk mitigation strategies
- Ensures GCP, regulatory compliance, internal SOPs and Working Instructions is maintained throughout the clinical trial lifecycle
KEY REQUIREMENTS:
- Bachelors or post graduate medical qualifications
- Ideally qualified with Diploma in Pharmaceutical Medicine and/or Diploma in Human Pharmacology
- At least 3 or more years of medical affairs and clinical research/development experience within a pharmaceutical or biotechnology company
- Comprehensive knowledge of the clinical development process and its critical paths
- Good command of spoken and written English ability
- Excellent written and verbal communication skills and good presentation skills
- Travel to markets within APAC would be required
- Commercial awareness
- Unquestionable integrity and positive attitude
- Great at building relationships, particularly with KOLs
- Willing and capable to manage multiple projects, tight timelines and responsibilities
