Jobs at Abbvie – Associate Medical Director Medical Affairs

Job Description:

The Associate/Assistant Director, Medical Affairs must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable US regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.

Job Responsibilities:

• Contributes to the development of and leads the execution of the medical education tactics, advisory boards, and thought leader engagement plan in line with onabotulinumtoxinA strategic plan.
• May be responsible for Medical Review (MR) training for on label, clinical data and disease state for onabotulinumtoxinA.
• With oversight, contributes to the development of medical migraine strategy for onabotulinumtoxinA in Migraine.
• Responsible for managing budget for assigned projects including consulting and vendor management.
• Aligns medical education and scientific initiatives with onabotulinumtoxinA Scientific Communication Platform
• Contributes to the generation of Medical Information (MI) communication content and supports training on MI materials.
• Contributes to the strategic and leads annual medical tactical planning initiatives.
• Provides subject matter expertise for MSL, health outcomes and commercial teams including competitive assessments and regular scientific literature reviews.
• Contributes to all launch readiness reviews/planning.
• Leads the US Conference planning and execution.
• Supports clinical and scientific data generation including alignment of the Investigator Initiated Study (IIS) strategy as needed to support external communication

Job Requirements:

• Should have a good understanding of legal and regulatory guidelines (e.g. knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals).
• Good understanding of Medical Affairs principles, study design and publications.
• Ability to interact externally and internally to support global business strategy.
• Ability to work effectively with different cross functional groups and have strong interpersonal and communication skills. (both oral and written)
• Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.
• Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc.
• Able to coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects.

Qualification & Experience:

• Medical degree, PhD, PharmD and/or other higher scientific degree. Preferably ‘board certified specialty qualification’ or equivalent and pharmaceutical industry recognized qualification e.g. MSc
• At least 3-5 years of biopharmaceutical/medical device industry experience, including substantial understanding of relevant therapeutic area required.

Job Details:

Company: Abbvie

Vacancy Type: Full Time

Job Location: Madison, WI, US

Application Deadline: N/A

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