Senior Manager, Medical Information
Astellas

Job Info

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 opportunity in Northbrook, IL.



Purpose & Scope:



Healthcare providers (HCPs) depend on the most reliable data to inform their best patient care. Patients depend on helpful information they can trust and understand to keep themselves healthy. The Senior Manager has direct impact on customer service by providing clear and accurate scientific information about Astellas products and the diseases we treat through engagement with internal colleagues, healthcare providers, patients and caregivers. Medical Information functional area strategic development and ability to influence internal and external stakeholders effectively regarding product/TA issues are central to this role.



Essential Job Responsibilities:




* Develop Medical Information strategy for assigned project(s) or operations through consolidation of input from appropriate stakeholders with identification of key clinical issues, gaps, and/or process improvements
* Manage, develop, review, and maintain Medical Information projects or operations as assigned. This may include collaborating with product partners and other internal and external stakeholders to:
* Document in Global Medical Information Database (GMID) and respond to unsolicited requests from HCPs and patients with appropriate data
* Provide drug compendia surveillance
* Contribute as US representative on Global Medical Content Teams
* Interpret Medical Information data to generate insights and gap analyses and influence effective change
* Conduct product and process training for contact center vendor staff and other stakeholders as requested
* Monitor Medical Information key performance indicators and foster process improvements toward excellence
* Review medical content of promotional and non-promotional materials and/or standard/custom response documents for medical accuracy and veracity, as assigned
* Collaborate with groups outside Astellas US MA (Medical Information global, Patient Experience, Legal, Commercial, Compliance, etc.) as appropriate
* Responsible for active participation on appropriate teams and committees as assigned
* Verify Medical Information Request Forms (MIRFs) from the field sales force are unsolicited per applicable country requirements
* Report potential adverse events and potential product complaints per Astellas policy and established processes
* Remotely respond to after-hours emergency/on-call requests
* Compliantly and professionally represent Astellas at medical meetings/conferences

Quantitative Dimensions:




* Manage personnel and/or multiple departmental projects or operations
* Collaborate with internal/external stakeholders as appropriate for project
* Extend scope of influence beyond Medical Affairs
* Handle multiple projects with a high level of efficiency
* Fulfill unsolicited medical information inquiries, completion of QA review tasks as assigned and potential adverse event reporting per Astellas policy and established processes



Organizational Context:




* The position reports to Medical Information Associate Director
* Works in a matrix environment; collaboration with leadership and product teams with respect to training and education. Collaboration with stakeholders at varying levels including, but not limited to Medical Affairs, Commercial, Legal, Regulatory and Clinical Development
* May manage personnel commensurate with level





Qualifications:

Required




* 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
* Working knowledge of the combination product regulations pertaining to documentation of combination product adverse event and quality reporting
* Very thorough knowledge of medical terminology, high quality medical references and online literature searching,
* 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.)
* Ability to work in a team/matrix environment
* Some travel may be required



Preferred




* Drug Information and/or pharmaceutical industry experience
* Proficiency in Medical Information Customer Relationship Management (CRM) systems and cloud-based content management systems (e.g., SharePoint, Veeva)
* Matrix team management



*LI-CH1

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled