This position will play a critical role in the development of a newly created Medical Information function within Pharmacyclics. Medical Information, within the Medical Affairs department, works closely with various functional areas within the organization to communicate accurate, consistent and timely information regarding products and therapeutic areas, including: contributing to clinical development initiatives, strategy building for brands, and creation of Medical Affairs infrastructure. This position will report directly to Medical Information, Communication and Education Director.
Key Accountabilities/Core Job Responsibilities:
- Develop department infrastructure for receiving, documenting and responding to product inquiries ensuring compliance with Office of the Inspector General Guidelines (safe harbor)
- Create and maintain a comprehensive written response document and FAQ database for Pharmacyclics products
- Respond to daily medical information requests from the professional community, patients, and internal colleagues with timely, balanced, scientific and relevant disease area and product information
- Diligently evaluate inquiries for adverse events taking appropriate action in compliance with company policy
- Assess and analyze Pharmacyclics and competitor product literature
- Communicate effectively with other functional groups to cultivate a positive relationship
- Develop product expertise and in-depth knowledge in target disease areas
- Maintain and utilize systems to manage medical and product relative information
- Participate in internal project teams and training programs
- Provide scientific support at various congresses
- Training and/or knowledge of Good Clinical Practice (GCP) and global regulations
- Experience with clinical research, publication activities, congress/conference/academy presentations
- Experience in literature searches, literature evaluation, and drug information concepts
Willing to travel 20% of time
- Ability to summarize complex information and present in a clear, concise, and scientifically accurate manner to a range of audiences
- Knowledge of ICH guidelines, FDA Drug Regulations with respect to DDMAC, PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, and OIG Compliance Program Guidance for Pharmaceutical Manufacturers.
- Think strategically; apply knowledge and analytical skills in a highly regulated environment; and align medical and commercial strategies
- Effectively build relationships and work with global medical thought leaders
- Excellent interpersonal, written and verbal communication skills
- Strong problem solving, decision-making, influencing, negotiation, organization and time management skills.
- 3+ years of experience in industry (e.g., biotech/pharmaceutical/medical device company, Contract Research Organization), academic research, or public health
Education Requirements (degree, certifications, etc.):
- PharmD or MD with 3+ years of experience in oncology
- 3 years ago - save job
Pharmacyclics, LLC is a clinical-stage biopharmaceutical company focused on discovering and developing innovative small-molecule drugs for...