Summary introduction to A.
Menarini
A.
Menarini, a subsidiary of leading Italy-based Menarini Group, is a biopharmaceutical company focused on developing, licensing and commercialising differentiated consumer and ethical healthcare brands.
Leveraging the extensive global infrastructure and go-to-market expertise of the Menarini Group, along with our unique insights into markets, patients and physicians, we develop biopharmaceutical brands from R&D, through to manufacturing, regulatory approvals, sales and marketing.
Main Objective of the Job
Lead, develop, and execute local medical and scientific brand plans and strategies.
Ensure delivery of local, regional, and global medical goals in data generation, knowledge exchange, and KOL engagements.
Oversee regulatory and quality activities, providing support when needed.
Successfully execute assigned regional registration projects and update management on regulatory policy changes.
Sits on the local leadership team
Responsibilities
Medical Affairs Activities
- Collaborate with stakeholders to provide medical and scientific support for products.
- Lead the development and execution of local medical and scientific brand plans to shape the market and support commercial strategies.
- Maintain updated medical knowledge of therapeutic areas to support product launch strategies.
- Lead the development and/or execution of key medical activities for brand strategy, including Advisory Board meetings, Expert Meetings, HCP slide briefings, Docquity, Patient Focus Groups, Medical Congresses, and CME for hospital listings.
- Create or support the development of medical/scientific materials and slide decks.
- Develop therapeutic area engagement plans with the commercial team to establish scientific relationships with KOLs.
- Interact with KOLs to share scientific data and ensure ethical standards and compliance.
- Execute local, regional, and global medical plans.
- Ensure local medical SOPs are updated according to company policies and local requirements.
- Manage the integrity and accuracy of scientific and medical data for promotional and non-promotional purposes.
- Research and provide scientific/medical data insights for new business opportunities.
- Support regulatory activities for new products/indications and label updates with scientific data.
- Provide medical/scientific support and training for internal staff, including disease training.
- Collaborate with Market Access to provide relevant scientific data for tender submission.
- Perform any other assigned duties.
Clinical Trials / Post-Marketing Studies / RWE
- Design, review, and execute clinical trials, post-marketing studies, and RWE data generation according to policy and regulations.
- Collaborate with internal and external stakeholders/KOLs/HCPs to support these initiatives.
- Lead/support/provide local medical and scientific input on studies, feasibility assessments, site development, recruitment, patient retention, and site management.
Identify local data gaps, design local study protocols, plan studies (including budget), input on site selection, and develop data dissemination strategies.
Promotional Material Review / Medical Information Enquiry (MIE) / Pharmacovigilance
- Ensure timely documentation, tracking, and response to all MIE inquiries.
- Respond to unsolicited medical inquiries with scientifically accurate, objective, and up-to-date data.
- Report Adverse Events (AEs), reportable events, and quality complaints according to SOPs.
- Review all promotional and non-promotional materials for scientific accuracy and compliance with local package inserts.
- Ensure compliance of promotional materials with PhAMA code, MMDA code, and Menarini’s Policies & Procedures.
Team Management
- Engage, inspire and galvanise employees around the functional vision and strategy to bring these to life in their areas of functional expertise
- In collaboration with the General Manager and HR Director, promote a strong culture of collaboration and teamwork across all internal departments and functions at a country and regional level.
- Function as a core member of the Singapore Leadership Team
- Ensure strong focus on talent development and ensure robust development and succession plans are in place and executed for the their function
- Recommend compensation plans for all medical personnel, including salary structures and incentive schemes aligned with Menarini’s Incentive Guidelines and Remuneration Policy
Position Requirements/Qualifications
Education / Qualifications
Medical graduate (e.g. M.D) preferred, or A Doctoral Degree in Life Sciences (e.g. Ph.D.)
5-8 years of medical affairs experience in the Pharmaceutical Industry
Skills
Strong communication, interpersonal, networking, leadership, managerial, and relationship-building skills.
Strategic, innovative thinker capable of driving multiple initiatives.
Knowledge of data analysis, statistics, and scientific presentations.
Meticulous with attention to detail.
Flexibility with disease area assignments.
Experienced in end-to-end product launch.
Experience in clinical trial/post-marketing study development and implementation is an advantage.
Highly collaborative with the ability to proactively address issues.
Goal-oriented, focused, energetic, enthusiastic, and self-motivated.
Excellent verbal and written communication skills in English.
IT savvy and process-oriented.
High level of knowledge of the regulatory environment.
#J-18808-Ljbffr