1. Medical/Scientific Leadership and Support
· Provide medical/scientific leadership, and support both inside and outside Co for Oncology products and therapeutic area to ensure that the business objectives of each product are realized; to support Co’s image and business in the market place, abides by the Co SOP’s principles and European Region working practices
· Provide medical expertise, guidance and background in alignment with the Global, Regional and Local Oncology business strategy goals and in compliance and close coordination with the Regional and Local medical management.
· Shape, own and execute the annual Oncology Medical Plan for country of responsibility; in alignment with the Global, Regional and Local Oncology business strategy goals, in compliance and coordination with the Regional and Local Oncology medical management. Plans and develops key projects to drive products through proper dissemination of medical and scientific information.
· Participate and provide input to global development programs and initiatives (i.e. clinical trial development, compliance and other cross functional initiatives)
· Interpret scientific information accurately
· Contribute to the compliance initiatives of the company so that internal and external standards are met in areas such as clinical activity, promotional activity, pharmacovigilance and product labeling
· Manage issues that may adversely affect business
· Provide medical expertise in preparing regulatory documents for the therapeutic area.
· Provide medical/scientific information for internal and external inquiries.
· Provide medical support in therapeutic area for pharmacoeconomic, pricing and reimbursement issues.
· Provides medical input into/at: POA development and communication, promotional activities and materials, scientific activities/materials
2. Marketing support
· Participate in Strategic Planning Process to provide insight, expertise and medical support to the business.
· Participate actively in the development of marketing strategies.
· Provide medical/scientific and regulatory input into the local annual Oncology business and “sign off” the tactical marketing plan and materials for ethical standards, medical correctness and Co SOP and local & regional regulation compliance, to ensure that the consumer is protected and Co complies with the Code of Practice and Medicines Act and all regulations
3. Sales Support/Education
· Provide support and training to the Sales force on medical matters relating to nominated products to ensure that sales opportunities are maximized.
· Prepares/delivers training on designated products / TAs to newly hired Medical Representatives and other relevant Co employees.
· Updates and reviews product knowledge of Medical Representatives and other relevant employees.
· Assists other training activities (role-plays, workshops, group presentations’ training etc.).
· Coaches the Field Force for medical aspects proactively or based on request.
4. External stakeholder management
Target and develop ongoing relationships with relevant bodies, institutes and opinion leaders for Oncology to ensure that they always have the accurate, updated and comprehensive medical information aligned with Co Oncology strategies, including but not limited to:
· Development working relations with key establishments (i.e. patient organizations, professional organizations, medical societies)
· Development and maintenance support and relationships with Key Opinion Leaders
· Participation in advisory/advocacy boards and develops the advocacy of the company brand and product brands
· Participation in activities related to building public relations between Co and external stakeholders
· Contributes to the selection of speakers for Co events/meetings.
5. Drug Safety and Regulatory Affairs
· Supports actively the Drug Safety Department and provides oversight for safety and product quality activities related to the assigned Oncology portfolio of products to ensure that appropriate medical recommendations are made or actions taken.
· Reviews the product regulatory documents (limited to summary of product characteristics (SmPC), patient information leaflet (PIL) only).
· Develops and updates the summary of product information (SPIs).
· Therapeutic and product knowledge advice for safety colleagues per request only.
6. Clinical Trials
· Provides, when requested, medical leadership and oversight for Oncology Clinical Trials to further support scientific strategies based on local regulations, corporate and international standards, and GCPs (Good Clinical Practice).
· Taking part and responsibility in the design, approval and implementation of clinical trials and NIS trials in country of responsibility so that good quality and reliable data are obtained and published according to DST SOP CT 24
· Management of IIRs in line with DST SOP CT 25
· Ensures adherence to Safety Review Plan
7. Cross Divisional Working
· Contribute to the work of cross functional product teams to facilitate a cohesive approach to the marketing and sales of Co products.
· Provides medical advice for QA and regulatory process and issues when needed.
· Ensures the implementation of the Country Quality Plan, under the MQCM coordination/guidance.
· Acquires quality processes and procedures knowledge.
· Implements quality processes and procedures.
· Demonstrates value proposition of quality and compliance to internal and external stakeholders.
· Applies a risk management approach.
· Participate to country CMC
8. Inspections / Audits
· Provides support for local inspections as defined by the local Regulatory Inspection Site Action Plan.
· Provide support for all audits under Medical Director accountability (if applicable), including audit corrective and preventive action plans (CAPAs).
· Audit preparedness.
9. FCPA implementation
· Coordination of administrative procedures in accordance with Co polices.
· Maintenance of all relevant and required FCPA documents and conditions.
· The employee shall also perform other Local and Regional tasks set by his/her manager within general framework of the employee’s job title.
· Ensures coaching of newly hired Junior Medical Advisors.
11. Medical Information
· Provides in country medical support, guidance and consultation for Oncology as required for Medical Information teams.
· Exhibits broad knowledge of assigned therapeutic areas and a solid understanding of pertinent disease state(s).
· Increases awareness of MI function with internal/external stakeholders.
· Creates and maintains local MI documents by ensuring that responses are medically and scientifically accurate, timely, fair balanced and meet customers’ needs. Ensures the alignment of response documents to local labeling.
· Participates as a member and MI resource on Business Units Product/Therapeutic Team(s).
· Represents Co by providing live MI support at scientific conventions/congresses; may serve as the lead for coordinating the MI function at scientific conventions/congresses.
· Maintains compliance with corporate and departmental trainings, standard operating procedures, and implementation guidelines.
12. Quality Awareness
· Ensure sound knowledge of regulatory requirements across Business Units and Platform Lines where appropriate.
· Interact with internal and external networks, including MQCM network and share best practices.
· Demonstrate value proposition of quality and compliance to internal and external stakeholders.
13. Pharmacovigilance and the compliance to rules and ethics codes
· Complete in due time the “Your Reporting Responsibilities: Monitoring the Safety, Performance, and Quality of Co Products” (YRR) training program and the annual re-training.
· Report information regarding drugs’ safety to the local Drug Safety Unit, in compliance with the YRR training materials.
· Have knowledge of and apply all the Compliance and Business Ethics rules.
· Immediately report any violation of the Compliance and Business Ethics rules.
14. Personal development through
· Active participation in Co trainings, assignments, projects.
· Active involvement in Co internal and external meetings from a commercial perspective.
· Identify personal areas of improvement.
· Maintain a balanced and healthy life.
REQUIRED SKILL SET
- MS Windows and MS Office user skills
- Driving license.
- High level of proficiency in both Romanian and English (written and spoken).
- Excellent verbal and written communication skills.
- Ability to interpret and relay technical information.
- Excellent time management.
- Medical writing experience is considered an advantage.
- Strong interpersonal skills, as well as excellent verbal communication and presentation skills
- Commercial acumen
- Pro-active in order to prevent problems
- Sense of responsibility
- Quality orientation
- Ability to coach and lead people
- Able to work in a fast-paced environment with competing priorities.
- Ability to work independently as well as part of a team.
- Degree in medicine (preferred) or PhD in health or life sciences
- Fluent in English : spoken and written
- Therapeutic area experience
- Pharmaceutical industry experience
- Experience in clinical trial protocol design and execution
- Profound knowledge of pharmacovigilance and regulatory legislation