- Provide Medical Affairs (MA) project support regionally and engage team members to solicit project concerns and ideas for improvement.
- Meet with MA Regional Head and Country Medical Leads to provide MA project status updates and develop risk mitigation.
- Provide Operational back up to manager, including addressing inquiries not requiring manager's direct attention to keep project/decisions on track.
- Contribute to strategic planning and track the status of activities/tactics associated with regional medical plans.
- Track the Americas MA Project and Programs and overall budgets; ensure spending is on track.
- Collaborate with Finance Business partners to align monthly reporting and quarterly forecasting.
- Help develop the 5-year budget plan including identifying risks and opportunities.
- Maintain a clear tracker with timelines and cost for all external Regional Americas MA activities planned for execution.
- Partner with Legal and/or Contracts and Procurement, to develop HCP and consultant/Vendor agreements, Master Service agreements, and Confidential Disclosure Agreements in Companion Application through to execution.
- Collaborate with designated Medical Affairs Americas staff, to manage the Procurement to pay process observing Global Sourcing and Procurement Policy and in the SAP Application.
- Manage, monitor, and track vendor set up, purchase requisitions, purchase orders issued, change orders, invoice tracking, and payment of vendors and Heath Care Professionals as outlined in Agreements.
- Collaborate with Global Operations Manager to manage internal review, approval and payment process of medical educational programs and grants, track project details, close-out, and archive.
- Support Americas MA Head in ensuring regional MA adherence to GXP and Code Compliance. Contribute to strengthening of Seqirus processes.
- Collaborate cross-functionally and across regions to harmonization processes.
- Collaborate with training administrators to ensure MA role-based training curriculum is assigned and SOP trainings are completed.
- Collaborate with Transparency Reporting Manager to ensure accurate tracking and reporting of "transfer of value" for Americas MA external HCP engagement activities.
- Ensure all medical program documents including transfer of value reporting are collected and archived for future compliance review and audits
- Degree in nursing, pharmacy or advanced degree in science/medicine (MD, PhD, PharmD) preferred.
- Educational background in clinical or scientific study in infectious disease and/or vaccinology, or public health is ideal.
- 5+ years' relevant pharmaceutical/ biopharmaceutical industry experience.
- Experience in Medical Affairs or Research and Clinical Development is preferred.
- Recognized subject matter expert in scientific writing, publications, data generation and therapeutic specialty in influenza.
- Prior experience in the pharmaceutical industry as a Publications Manager is preferred.
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Medical Affairs Operations Senior Manager-Americas - Summit, United States - CSL Seqirus
Description
This role will require the candidate to be onsite in Summit one day a month and as needed.
The Opportunity:
Under the guidance of the Head of the Americas Region, Medical Affairs, the Medical Affairs Operations manager provides operational support in the execution of regional Medical Affairs programs and projects including medical education programs, scientific advisory boards and scientific symposia at regional congresses. You will ensure accurate tracking of project performance for existing and newly created contracts and budgets. You will apply project management best practices in the initiation, planning, execution, maintenance, and closing of projects.
The Manager will also highlight risks, timeline delays and other issues. We ask that you be a team player with well-developed skills for gaining the cooperation of others and ensuring effective communication among team members.
The Role:
Your Skills and Experience:
Our Benefits
CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL Seqirus employee.
About CSL Seqirus CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.We want CSL Seqirus to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus
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