Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Senior Manager, Medical Information, Oncology opportunity in Northbrook, IL.
Purpose & Scope:
This role has a direct impact on customer service, including the provision of medical information for Astellas products in response to unsolicited requests from both healthcare professionals and patients/care givers within the Medical Affairs Americas (MAA) region and conducting quality monitoring, quality assurance (QA) and medical review of materials within the Medical Affairs area of responsibility. Medical Information therapeutic area strategic development, as well as active participation in various committees/teams is central to this function.
Essential Job Responsibilities:
Develop Medical Information strategy for assigned therapeutic area (TA)/product through consolidation of input from appropriate stakeholders with associated identification of key clinical issues or gaps
Execute broader Medical Information activities as assigned, such as but not limited to any of the following: leading strategy for medical information content at monthly therapeutic area meetings, SME team operations, SME regional team meetings
Manage product/TA as assigned, including the development, review and maintenance. This may include standard response documents, custom response documents, Academy of Managed Care Pharmacy (AMCP) Dossiers, compendia, product bibliographies, and supporting regional call center unsolicited medical information request escalations. Supports Medical Information activities throughout the region (including US, Canada, LATAM)
Provide product education to call center, vendor, field medical, Commercial and other departments as requested
Collaborate with groups outside Astellas MAA (global Legal, Commercial, Regulatory, etc.)
Document all inquiries for medical information in the Global Medical Information Database (GMID)
Report potential adverse events and potential product complaints per Astellas policy and established processes
Conduct medical review for commercial/non-promotional medical materials and/or standard/custom response documents, as assigned
Remotely respond to after-hours emergency/on-call requests (approximately 2 months/year)
Represent Astellas at medical meetings/conferences/advisory boards/global/regional team meetings with a high level of communication skills
Management and development of personnel and/or multiple products/TAs
Collaboration with internal/external stakeholders as appropriate for TA/product
Handling multiple projects with a high level of efficiency
Fulfillment of unsolicited medical information inquiries, completion of medical review tasks as assigned and potential adverse event reporting per Astellas policy and established processes
Healthcare professional with a Bachelor's Degree or higher (e.g., pharmacist or nurse)
At least 3 years clinical practice experience and/or pharmaceutical industry experience
Thorough understanding of pharmaceutical industry workings, legal/regulatory/compliance requirements and guidelines with respect to medical affairs in the pharmaceutical industry
Ability to review/understand complex scientific and medical data from clinical and non-clinical trials and summarize content in both written and verbal forms
Very thorough knowledge of medical terminology, advantages and disadvantages of available medical references and online literature searching, and most company products
Excellent project management and organizational skills with the ability to prioritize and multitask
Excellent oral and written communication skills; sound negotiation skills
Excellent computer/technical skills with proficiency in various technology platforms such as Medical Information Customer Relationship Management (CRM) systems, cloud-based content management systems (e.g., SharePoint, Veeva), and the Microsoft Office Suite (e.g., Word, Excel, PowerPoint, etc.)
Astellas Pharma US, Inc., is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Located in Northbrook, Illinois, the company serves as the headquarters for the Americas and employs nearly 3,000 people. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.
Our commitment to changing tomorrow is measured not only by our focus on bringing innovative and effective new medicines to patients and physicians, but also by the importance we place on the impact we can make within the communities where we work and live. Astellas supports many causes and has created Changing Tomorrow Day, an annual, worldwide volunteer event, to demonstrate this commitment.