Senior Medical Affairs Manager
3 weeks ago
PRIMARY OBJECTIVE:
The position represents the affiliateâs medical/ scientific voice of expertise for assigned product(s) and relevant therapeutic areas. The position provides medical / scientific expert advice / guidance to key customers for assigned products and relevant therapeutic areas, including scientific exchange and professional relationship development with key opinion leaders. It provides medical / scientific input into marketing strategy and key commercial initiatives, as required, and medical / scientific support for medical department activities under the direction of the Head of the affiliate medical function.
EDUCATION/QUALIFICATIONS/EXPERIENCE:
Bachelorâs degree in a scientific discipline, preferably with Pharm D.
1 year MSL/CRA/MIS experience in pharmaceutical company is appreciated
Organizational skills in planning and overseeing multiple parallel long-term projects
Demonstrate ability to take direction and work both independently and as part of a team
General knowledge on drug development and clinical research an advantage
Pro-active approach to assigned responsibilities, with responsiveness to prioritize according to needs of the project
Good computer skills and ability to learn and to adapt working with IT systems
Knowledge of ICH, GCP, regulations, industry practices and applicable standards
Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
Demonstrates strong communication skills (written, verbal, presentation and facilitation skills)
Willingness to travel upcountry
CORE JOB RESPONSIBILITIES:
Support the overall operations of a medico-marketing activity, medical project and medical information by participating in process improvement initiatives, tracking and reporting key operational metrics, and ensuring audit readiness
Review and approve promotional materials and scientific material development
Identify new and changing trends in therapeutic area, and proactively communicate strategic insights to the cross functional team
Provide scientific and strategic support into marketing strategy and key commercial initiatives
Foster and maintain relationships with key opinion leaders to build outstanding advocacy
Develop and maintain in depth knowledge for assigned product(s)/ relevant therapeutic area(s)
Co-operation on clinical research activities with the global and regional by taking responsibility for the implementation/ manage of local clinical trials, including IIS, BE, feasibility studies and non-interventional clinical research activities throughout project
Assures that clinical research program design meets scientific objectives and is aligned with our Medical Affairs Strategy
Building relationships with Investigators and applying their inputs to enhance study design and protocols
Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas
Serves as scientific expertise on clinical research matters and govern regulatory requirements
Administer and maintain appropriate documentation such as protocol approval and related study expenditure to internal stakeholders
Manage internal TARC review and approval of local clinical activities in assigned therapeutic area(s)
Lead local clinical trial application through central research committee (if required)
Ensure compliance with Corporate and Divisional Standard Operating Procedures SOPs, Good Clinical Practice, and local regulatory requirements pertaining to the conduct of clinical studies
Complete data entry to monthly metric
Manage CLIMATE and Clinical Tracker Sharepoint
FUNCTIONAL COMPETENCIES:
Project Management
Able to plan organize, assess and monitor the projects with team, stakeholders and sponsors to ensure delivery on timelines. Monitors and controls project performance
Scientific prominence
Provides strategic direction based on most up to date scientific knowledge / medical practice. Act as a scientific / medical liaison to cross functional teams
Stress resistance
Able to work under pressure
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