TASKS AND RESPONSIBILITIES
- Provide regulatory, quality assurance, scientific and clinical support to the commercial activities.
- Support and contribute to the successful launch of a key new product.
- Coordinate the clinical development activities for all new and existing medicines to support the development business.
- Ensure that the contribution from the development of new products are appreciated and in accordance with the funding and expectations from the R&D organization.
- You are responsible for local trial activities, mainly Investigator Initiated Trials.
- Ensure timely regulatory approval of new medicines, dosages and forms, plus the maintenance of existing marketing authorizations in line with the business needs.
- Oversight of a well-functioning Pharmacovigilance system including a timely and appropriate reporting to authorities regarding any changes in prescribing data and adverse events.
- Ensure medical/scientific approval of all promotional materials and communications.
- Provide medical support and leadership for market access initiatives including assessments / reviews from local pricing and reimbursement boards.
- Work closely with Global Medical Affairs and HQ.
- Develop and implement local key opinion leader plans in close cooperation with Global Medical Affairs and partners.
- Develop strong relationships with key opinion leaders.
- In cooperation with the Drug Safety you will be the responsible person for wholesale.
- You must ensure that procedural documents and policies are maintained and implemented.
- Lead active monitoring and continued assessment of safety profile.
- Critical review of safety data and literature during all phases of the life cycle of a defined portfolio of medicinal products.
- You will lead the cross-functional Safety Management Teams regarding safety issues.
- Escalate all safety relevant matters to the appropriate decision making level with proposals for solutions based on analysis of the available information.
- You will be responsible for Benefit-Risk Management and Clinical Trial Safety in all aspects of Benefit-Risk Management (risk identification; risk assessment; risk communication; risk mitigation; evaluation of risk mitigation).
- Clinical Development and/or clinical safety product submitted to Regulatory Authorities for marketing authorization.
REQUIREMENTS
- Qualified Medical Doctor (MD)
- Min. of 5 years experience in clinical practice, research or pharmaceutical medical affairs.
- Manager / Leadership experience as a Medical Director.
- Experience with pharma industry and healthcare compliance requirements.
- Experience in clinical research.
- GCP trained would be a plus.
- Required experience in public scientific presentations.
- Expert in the Safety Regulations with comprehensive knowledge of global drug/vaccines safety regulations, guidance’s GVP and best practices.
- Understanding of current approaches to balancing the benefits and risks of products, in particular, experience developing and implementing a risk management plan acceptable to FDA and EMEA.
- Familiarities with cross-functional principles of drug development, pharmacology, biostatistics, clinical trial methodology, pharmacoepidemiology, medical safety and pharmacovigilance.
- Sound clinical acumen and in depth therapeutic area/product knowledge and able to assess, manage and communicate appropriately with respect to the safety profile of medicinal products.
- Strong communicator.
- Excellent English language skills, both written and spoken.
- Experience in medical and scientific writing would be an asset.
- Good networking and team skills for successful cooperation with internal and external customers.
- Self-confident, proactive and trustworthy.
- Excellent communication skills, including formal presentation skills.
