Medical Manager (m/w/d)

    • Munich, Germany

Job Description

We are looking for a Medical Manager (m/w/d) for our site in Munich

Study Management

  • Leads the coordination, execution and follow up of the clinical projects (PhaseIV studies, NISes, IITs, SRAs, Registries, etc.) in Germany and Austria:  
    • Ensures timely generation and dissemination of real-life-data according to local SOPs
    • Leads the internal review and approval process of clinical projects
    • Supports and advises the MSLs on study site identification and management
    • Acts as the point of contact for all clinical projects executed in Germany and Austria region for the internal stakeholders (e.g. Biogen Biosimilars head of clinical research, Biogen Biosimilars global medical affairs head, affiliate general manager etc.):  and external stakeholders (e.g. Investigators, CRO, study site, study lead) to support study concept, protocol and contract development as appropriate.
    • Tracks and manages the budget for clinical projects in Germany and Austria
  • Stays up to date with therapy advances, current research, medical scientific knowledge and detailed knowledge on Biogen products & relevant Disease Areas

Medical support

  • Tracks and manages medical BBU budget in Germany and Austria alignment with the Biogen Biosimilars Medical Affairs central function
  • Tracks and supports ICP planning and execution
  • Ensures appropriate internal documentation of BBU projects according to internal SOPs and policies and external law and codex

Medical Affairs

  • Act as internal scientific/medical expert advisor to other staff members, conduct medical/scientific education and liaise with global/EU+ medical team
  • Support to marketing and market access functions in product strategies
  • Supports the implementation of medical strategies through active participation at meetings, local congresses, implementation of medical education initiatives, and panel discussions
  • Facilitate and contribute to the organization of meetings (e.g. local advisory boards, educational meetings etc.)
  • Provides local support for Regulatory Affairs, Drug Safety, Medical Information and Clinical Research/GCO as appropriate
  • Acts as compliance approver for medical and marketing materials for local use

Present and discuss medical science related to our products to HCPs

  • Builds peer to peer relationships with healthcare professionals and institutions to establish and maintain a therapeutic leadership position.
  • Communicates recent scientific knowledge/data on Biogen products in approved and off-label indications.
  • Provides support for field force and other medical training as required

Establish and maintain effective collaborations with Regional & Global Medical Teams

  • Act as an active member of Regional networks

Qualifications

  • Clinical/scientific experience in the therapeutic area
  • Experience in medical communication and education
  • Experience of working with IITs / Post-Marketing study projects
  • Proven expertise in working with and within local regulations and code of practice
  • Experience in promotional material reviews
  • Proven experience in working in cross-functional teams
  • Understanding of health economics and outcomes

Education Requirements

  • BSc; Advanced terminal degree preferred (MD, PhD, PharmD, DNP in medical specialty) or equivalent combination of experience and education
  • Min 3 years of experience in medical affairs or other relevant role or an experience in scientific project execution and management

Additional Information

The Medical Manager works closely together with the other Medical Manager BBU (MM) and coordinates and provides clinical, operational and administrative support to scientific projects as post-marketing studies (NIS, IIT, SRA) and provides clinical/medical expertise internally and externally ensuring understanding of the disease area and Biogen products as appropriate. The MM is integral to building and maintaining valued constructive partnerships with internal key stakeholders (e.g. cross-functional BBU team) and external vendors (e.g. CRO, medical writer, agencies) and stakeholder (e.g. KEE).  The MM contributes to company success on scientific projects. The MM is also responsible for medical budget tracking and management. The MM ensures all clinical projects are managed according to local SOPs.


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