Senior Director - EpiPen Medical Affairs - Mylan - Pittsburgh

Job description
For Us, It’s A Mission
At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world’s 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what’s right, not what’s easy. If you are a doer and have a passion for serving others, we want to talk to you.

Make a Difference
At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here’s how this role will help:
Occupies a key leadership role for one of the company's verticals Allergy (EpiPen® Auto-Injector). Will work in a leadership role within a cross-functional team of medical professionals (medical directors, health outcomes, biostatistics, clinical operations, medical information, safety, regulatory, and field medical science liaisons) in planning and execution of all aspects of medical related Allergy product support as directed by the Executive Director, Medical Affairs.
Directs EpiPen® Auto-Injector publications and dissemination of information in support of the Company's products by means of a publication plan/team, product information letters/responses and medical education processes.
Responsible for approval of all EpiPen® Auto-Injector product promotional material, in compliance with corporate standards government/industry regulations, ensuring that information is scientifically accurate and medically appropriate.
Provides medical support to product planning and on the impact of line extensions, new indications, formula changes, and opinion leader development and publication strategies for therapeutic area products
Develops and maintains close professional relationships with influential members/opinion leaders (physicians and researchers) within pertinent medical community. Fosters the establishment and maintenance of external scientific advisory boards and assists in advocacy development.
Accountable for medical representation on various teams and committees responsible for sharing in the development of short and long-term business strategies and objectives, and is responsible for implementation of medical programs and procedures in support of these objectives.
Remains informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc. Actively attends core business team meetings, advisory board meetings, and steering committee meetings.
Reviews and supervises all aspects of post-marketing clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, and clinical trial guidelines.
Ensures a strategic approach to such programs, and the development of clinical data to maximize the commercial potential of the Company's products. Maintains approval of all protocols and conduct of all clinical studies in adherence to both Company standards and government/industry regulations. Provides medical review and approval of regulatory documents pertaining to the work of the EpiPen® Auto-Injector medical team.

Desired Skills and Experience
Make Our Values Your Values
Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the qualifications for this position:

5+ years of experience in the Pharmaceutical or Biotech Industry working in Medical Affairs and/or clinical research and development or related fields.
Board certified or experiences in Allergy/Immunology a plus.
Medical Degree or Advanced Degree (PhD, Pharm D) necessary
MD or Pharm D
Board certification/eligibility in therapeutic area related to the position a plus.

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