id: NDk1MjIwMCA3

reference: 4952200

documentId: 4952200

connectionPointId: 7

lastModificationDate: 1551421334716

stillingsbetegnelse: Head of Medical, Denmark

jobbeskrivelse:

Job Description

In line with the global medical strategy the Head of Medical sets and provides the strategic direction for affiliate Medical department and has overall responsibility for all the affiliate Medical activities, including local Medical tactics and operations, as well as relevant pharmacovigilance (SABR Safety and Benefit/Risk), regulatory and compliance aspects for all medical products and related disease areas within the country. 

As Head of Medical, you will also support and ensure the Biogen Medical department vision of maintaining a best-in-class Medical function to provide services in line with the best governance and performance principles in the best interest of patients, Health Care Providers (HCP), and the company.

Primary Responsibilities
External stakeholders
- Establishes the scientific reputation of local Biogen affiliate; develops strong peer-to-peer scientific partnerships with thought leaders in alignment with overall Biogen strategy
- Identifies current and future unmet medical needs, building clinical plans to address relevant questions

Leadership and medical team
- Plays a leadership role within the Medical Affairs teams, including providing best-practice sharing across countries, therapeutic areas, products etc.
- Lead, motivate and enhance the performance of the Medical Affairs team through direct reports to achieve agreed objectives
- Achievement of budget plans
- Agreed contracts and processes in place with outsource partners
- Ensures appropriate resource/people to fulfil objectives

Medical plans and activities
- Leads development of the affiliate medical plan aligned with local, regional and global plans, partnering with the affiliate management team, including Value & Access, Marketing, Sales and Regulatory Affairs, establishes and executes a coherent local business plan that addresses patient needs; identifies measurable goals to insure execution of local medical affairs plan
- Identifies need for, and lead RWE/Quality Projects in close collaboration with medical and cross functional teams and clinics/HCP´s
- Develops and manages budgets for medical activities and provides input into the affiliate budgeting and planning process
- Ensure appropriate training as required to all business/affiliate colleagues on brands and diseases.
- Ensures timely, accurate and appropriate responses to all medical enquiries
Partnering with Commercial 
- Partners and collaborates with Commercial and Value & Access to demonstrate medical value of Biogen products relevant to local external stakeholders (payers, HCPs, agencies); may include providing input to all clinical trials (pre and post-marketing), developing and executing phase IVs, registries, etc. (master real-life medicine)

Partnering within R&D
- Acts as a local partner for R&D for pipeline and new products
- Supports regulatory strategies for registration of new products by providing local expertise

Governance/compliance
- Ensure compliance with external laws and internal regulations regarding the appropriate conduct of Affiliate Medical activities
- Ensure consistent application of Biogen internal standards and local regulations in medical affairs including those related to promotional material, medical and scientific relations, medical information
- Ensure local medical procedures are in place where necessary
- Sponsors audits/inspections under Medical Director accountability
- Provides support for audits on PV, regulatory as required.
- Responsible person for medical information and promotion in Denmark
- Ensure appropriate review of all promotional and educational materials including compliance with the local and international rules and regulations and Biogen ‘s internal SOP’s and Product Licenses and SmPC’s.  
- Be a core member of the grant review committee

Qualifications

- Knowledge and understanding of local health care system / market dynamics, regulations, policies and SOPs
- Demonstrated strategic approach to implementation of scientific communication programs on disease areas and treatments
- Demonstrated ability to build & lead a team and develop a high performing organization, and experience from leading medical teams and departments
- Has demonstrated leadership skills and good management and planning skills
- > 3 years of Pharma industry experience.
- Good understanding of marketing principles and strategies
- Extensive knowledge of all aspects of drug development, GCP and local regulations, including regulations of Promotional materials. Familiar with global regulations
- Experience from Marketing Authorization Application (MAA) processes for new drug application
- Extensive knowledge of clinical trial design statistics and pharmacokinetics.
- Experience from involvement in reimbursement applications

Education

- Preferably MD degree with clinical experience 
- PhD is an advantage but not mandatory
- Preferably course in Pharmaceutical Medicine

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2212

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: BIOGEN (DENMARK) NEW MANUFACTURINGApS

source: DK-STAR