Astellas Pharma Sr. Manager Medical Information in Northbrook, Illinois
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and 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. This role will also potentially be medical reviewer of promotional materials as well as create and lead non-promotional medical material.
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
May participate in review of, and in some cases creation of, non-promotional medical materials and lead review process of those
May participate in medical review of promotional material of products.
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
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
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
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
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
Category Medical Affairs
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans