Description
The Associate Director Medical Affairs manages the medical affairs department for Bulgaria, Albania and Macedonia, and is responsible for all aspects of local Medical Affairs (MA), including:
- Serving as a member of the local leadership team and as the Chief Medical Officer.
- Lead Country Medical Governance Council and ensuring that functional groups with Medical (Clinical, Regulatory, Safety and Medical Affairs) are collaboratively planning, executing and measuring all activities with an emphasis on customer-focus and compliance.
- Overseeing all local MA activities with a focus on local MA strategy and the development of Medical Affairs Plans (MAP)
- Establishing, managing and owning local Key Opinion Leader (KOL), investigator, and other key stakeholder relationships
- Representation of the company with KOL and the press
- Overseeing the medical information manager/medical advisors to provide accurate, comprehensive, medically relevant information services incl. the tracking in the DPOC system
- Developing local clinical evaluations..
- Advising business units on medical and scientific matters.
- Providing medical and scientific input and advice to business units, market access/access alliance functions and others as required, as well as input into Health Economics.
- Providing medical and scientific training to the field force and others as required
- Identifying licensing opportunities.
- Ensuring compliance with all applicable country and internal regulations (incl. scientific approval of promotional materials, FCPA, etc.) and acting as member of the compliance committee
- Enhancing the company reputation and profile through an external focus, by representing the company on cross-company boards and industry associations.
The Associate Medical Affairs Director must be able to function well within a matrix organization. The position reports directly to the Sub region Medical Director with a solid line and into the country General Manager with a dotted line.
The job holder will interface closely with all his colleagues from the management team and here in particular with the Business Franchise Leads and Sales Directors and the Country Operation Head of Regulatory Affairs, the Head of Country Clinical Trial Operations, the Head of Pharmacovigilance and the Head of Quality Control.
The Associate Medical Affairs Director will also manage some country MA personnel, such as Medical Advisors and will be directly responsible for one ore more therapeutic areas.
Qualifications
The Associate Medical Affairs Director position requires a Medical Degree (preferred) and only in exceptional cases PhD/PharmaD in life science, along with significant Medical Affairs experience. The job holder ideally has close familiarity with the other medical functions within the Local Medical Council (Clinical Research, Regulatory Affairs, Pharmacovigilance) and a demonstrated ability to interact effectively with medical opinion leaders and regulatory/reimbursement agencies. He/she should also have the ability to influence and manage in a matrixed organization and be able to communicate in fluent Bulgarian and English.
CORE COMPETENCIES
Interpersonal Savvy ? Relates well to all kinds of people, up, down, and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.
Decision Quality ? Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by other for advice and solutions.
Building Effective Teams ? Blends people into teams when needed; creates strong morale and spirit in his/her team; shares wins and success; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates a feeling of belonging in the team.
Process Management -- Good at figuring out the process necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others cannot; can simplify complex processes.
Managerial Courage ? Does not hold back anything that needs to be said; provides current, direct, complete, and ?actionable? positive and corrective feedback to others; lets people know where they stand; faces up to people problems on any person or situation (not including direct reports) quickly and directly; is not afraid to take negative action when necessary.
ADVANCED COMPETENCIES
Conflict Management ? Steps up to conflicts, seeing them as opportunities; reads situations quickly; good at focused listening; can hammer out tough agreements and settle disputes equitably; can find common ground and get cooperation with minimum noise.
Motivating Others ? Creates a climate in which people want to do their best; can motivate many kinds of direct reports and team or project members; can assess each person?s hot button and use it to get the best out of him/her; pushes tasks and decisions down; empowers others; invites input from each person and shares ownership and visibility; makes each individual feel his/her work is important; is someone people like working for and with.
Business Acumen - Knows how business work; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace
TECHNICAL COMPETENCIES:
List the technical competencies, related elements and proficiency levels required for this position.
1. Scientific and Medical Knowledge
Broad knowledge of products and therapeutic areas
Drug development and life cycle management knowledge
Medical background and skills
2. Technical Communications
Technical writing and verbal communication skills
Presentation skills
Ability to communicate with health authorities and other key stakeholders
3. Regulatory Compliance Knowledge
Ability to review promotional material
Contribute to the translation of Summary of Product Characteristics (SmPC) and patient leaflet to local label
Knowledge of local, regional, and global laws, policies, requirements, guidelines and Company operating procedures
Ability to provide input to regulatory and compliance inspections
4. Medical Affairs Strategy
Interact with business units and global MA to develop local MA strategy and contribute to the shaping of global MA strategy
Oversee implementation of local MA initiatives through MA or Clinical Operations
Manage interaction with strategic review team and Investigators to align with MA strategy
5. Business Acumen
Ability to train sales field force within the local code
Ability to understand local business goals and objectives
Contribute to country operations strategies
Process improvement, metrics development and monitoring
Business operations knowledge
Understanding of commercial and research business
Financial acumen
Application and management of grants and donations
Ability to manage non-clinical audits
6. KOL Relationship Management
Understand and interact with KOLs
7. Safety and Pharmacovigilance (PV) Knowledge
Understand PV legal and corporate requirements to support reporting to health authorities
Manage medical information
8. Clinical Operations Knowledge
Provide input in site selection, recruitment, performance management
Interact with health authorities
Provide input to protocol feasibility
*LI-LS1
Job: Medical Affairs
Job Title: Associate Director Medical Affairs
Primary Location: EMEA-Bulgaria-Sofia-Grad-Sofia
Employee Status: Regular
Number of Openings: 1
Job Segments: Medical, Manager, Pharmacovigilance, Law, Outside Sales, Healthcare, Management, Legal, Sales
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