Career Category

Medical Affairs

Job Description

Accountabilities

• To provide state-of-the-art medical insight into the therapeutic area (TA) and/or specific molecules to Local and International teams
• To serve as a single point of contact for Local and International teams in area of responsibility

Reports to

• Affiliate TA head (Director)

Responsibilities

• Product(s) lifecycle management
•  Acting as therapy area expert to provide strategic medical input into the company decisions on specified therapeutic areas as required
• Working collaboratively within the brand team to provide strategic medical and scientific input into brand plans to develop an appropriate product strategy
• Working collaboratively with the access team to provide strategic medical and scientific input into price and reimbursement discussions.
• Leading and developing the Local Medical strategy and Medical activities for the product(s) in accordance to internal and external regulations
• TA and/or product specific Medical training
• Management of internal and external relationships within are of responsibility
• Ensuring consistency of Medical content and scientific messages across various tools and materials
• Works with Local DFO to ensure preparation, implementation and completion of AST’s (Amgen sponsored studies)
• Develops study protocols and data analysis plans for Local AST’s; supports and executes Local study protocol preparation, filing, review and approval in line with Amgen processes and policies
• Supports Local DFO in participation and completion of International development studies in the country
• Participates in the development of International strategies and tactics in close collaboration whit the IML
• Visits selected KOL’s and study groups for strategic discussions and protocol development
• Reviews Local ISS proposals prior to approval and ensures appropriate Local review prior to IPRC submission, if applicate

Authority

• Signs off Local R&D plan for his/her area of responsibility
• Approves scientific content of Local symposia/workshops/publications/ promotional materials/medical section of reimbursement files
• Signs off Direct Outside Expense at signature level

Outputs

• Brand/disease specific parts of Local R&D plan
• Cross functional development of the Brand Plan
• Local support for Medical questions, feasibility and trial strategy
• Local Product Lifecycle Plan
• Protocols and other study documents for local AST
• Medical expertise for the review of promotional and scientific documents
• (e.g. symposia, publications etc.)
• Local R&D brand/disease related results according to goals and metrics

Qualifications

• Medical education (Medical Doctor), therapeutic area experience is preferred

Minimum Requirements

• Minimum of 2 years in pharmaceutical industry, or proven industry collaboration in academia
• Experience in affiliate Medical department or Clinical Development
• Experience with clinical study management and conduct
• Knowledge of commercialization and business practices

Preferred Requirements

• Knowledge of pharmaceutical product development, product life cycle and commercialization process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory and Medical Affairs
• Scientific background
• Clinical practice experience
• Network of customer contacts in therapeutic area
• Finance and budgeting experience

Competencies

• Medical and scientific expertise
• Fluency in English, both oral and written communications
• Strong communication and presentation skills
• Continuously expanding medical and scientific knowledge as well as market knowledge
• Strong clinical research knowledge (study design, study evaluation, medical writing skills, expert panel conduct, symposium and workshop management, KOL management)
• Strong customer orientation; science-based
• Ability to work in a cross -functional team (e.g., Commercial, Clin development, EU teams, HE, Regulatory, safety, ets.)
• Demonstrates leadership skills

.