[Hiring] Sr. Specialist, Medical Affairs Strategic Operations @Organon
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Role Description
Reporting to the Head of Strategic Operations and Chief of Staff (CoS) for the Vice President of Medical Affairs Outcomes Research (MAOR), the Senior Specialist will support the work of the Strategic Operations team. This includes but is not limited to:
• Management of the review process for non-interventional studies, independent publications, local data generation, and investigator-initiated studies
• Ongoing oversight of investigator-initiated studies
• Management of Independent Medical Education grants (US only)
Primary Responsibilities:
• Manage the Non-registrational Study Approval Process (NORSAP) for all therapeutic areas including coordinating the meetings, taking minutes, and follow up post meeting as required
• Engage with internal and external stakeholders to ensure completeness of submissions to the NORSAP Committee
• Ongoing management of approved Investigator Initiated Studies (IIS’s) including contracting, drug supply, study tracking, and close out
• Oversees and executes on the end to end US Independent Medical Education grants review and approval process including facilitation of Review Committee Process
• Maintains knowledge of organizational strategic focus, inter-departmental activities, current clinical and scientific concepts, internal and external governing policies, and adult-learning modalities in medical education, contract negotiation and interpretation, budget and project management, and vendor management
• Maintains financial and/or organizational priorities maintaining appropriate processes and financial controls to ensure completion of programs within established budgets
• Ensures compliance with existing internal and external guidelines as they pertain to professional relations, patient advocacy, Investigator Initiated Studies and Independent Medical Education, as well as Organon’s internal standards based on its interpretation of the applicable laws and regulations
• Actively manage the successful and compliant contracting, payment and tracking process
• Engages in special projects and other duties as assigned
Qualifications
• Excellent interpersonal communication skills
• Ability to problem solve and critical thinking skills
• Good written communication skills
• Experience with Microsoft Excel, PowerPoint, and Word
Requirements
• At least 3 - 5 years of operations support in Pharma or similar background
• Vendor Management
• Preferred experience with Investigator Initiated Study Management
• Preferred experience with Independent Medical Education (US)
Education
• Bachelor’s degree in business or similar
Benefits
• Retirement savings plan
• Paid vacation and holiday time
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans
Salary Range
Annualized Salary Range (US): $103,100.00 - $175,300.00
Apply tot his job
Apply To this Job
Role Description
Reporting to the Head of Strategic Operations and Chief of Staff (CoS) for the Vice President of Medical Affairs Outcomes Research (MAOR), the Senior Specialist will support the work of the Strategic Operations team. This includes but is not limited to:
• Management of the review process for non-interventional studies, independent publications, local data generation, and investigator-initiated studies
• Ongoing oversight of investigator-initiated studies
• Management of Independent Medical Education grants (US only)
Primary Responsibilities:
• Manage the Non-registrational Study Approval Process (NORSAP) for all therapeutic areas including coordinating the meetings, taking minutes, and follow up post meeting as required
• Engage with internal and external stakeholders to ensure completeness of submissions to the NORSAP Committee
• Ongoing management of approved Investigator Initiated Studies (IIS’s) including contracting, drug supply, study tracking, and close out
• Oversees and executes on the end to end US Independent Medical Education grants review and approval process including facilitation of Review Committee Process
• Maintains knowledge of organizational strategic focus, inter-departmental activities, current clinical and scientific concepts, internal and external governing policies, and adult-learning modalities in medical education, contract negotiation and interpretation, budget and project management, and vendor management
• Maintains financial and/or organizational priorities maintaining appropriate processes and financial controls to ensure completion of programs within established budgets
• Ensures compliance with existing internal and external guidelines as they pertain to professional relations, patient advocacy, Investigator Initiated Studies and Independent Medical Education, as well as Organon’s internal standards based on its interpretation of the applicable laws and regulations
• Actively manage the successful and compliant contracting, payment and tracking process
• Engages in special projects and other duties as assigned
Qualifications
• Excellent interpersonal communication skills
• Ability to problem solve and critical thinking skills
• Good written communication skills
• Experience with Microsoft Excel, PowerPoint, and Word
Requirements
• At least 3 - 5 years of operations support in Pharma or similar background
• Vendor Management
• Preferred experience with Investigator Initiated Study Management
• Preferred experience with Independent Medical Education (US)
Education
• Bachelor’s degree in business or similar
Benefits
• Retirement savings plan
• Paid vacation and holiday time
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans
Salary Range
Annualized Salary Range (US): $103,100.00 - $175,300.00
Apply tot his job
Apply To this Job