Medical Information Senior Manager
il y a 1 semaine
The Senior Manager of Content Management will assist in the content creation efforts for the Global Medical Information function which will ensure timely and accurate responses are provided to unsolicited medical and clinical inquiries from healthcare professionals, patients, clinical sites and other healthcare organizations. This position will report to Senior Director, Medical Information.
Key Accountabilities/Responsibilities
- Responsible for liaising with the content creation lead to help with creation and maintenance of global and US MI response documents that are scientifically accurate, fair balanced, and that meet customer needs, while using the expertise of other argenx functions
- Supports the localization of materials for the US and Global markets while ensuring the information is aligned with the local labelling
- Develops and maintains relevant knowledge repositories, including MI response documents and publications
- Supports the review and approval of outbound MI responses
- Assists with management and training of MI (vendor) services and performs routine quality control of case handling
- Ensures documentation of receipt and response to all MI requests while verifying that the documentation of the inquiries and responses accurately and completely comply with relevant Standard Operating Procedure (SOP)/ Work Instruction and regulatory guidelines
- Ensures that adverse events and product quality complaints are processed in accordance with company SOPs
- Exhibits broad knowledge of assigned therapeutics areas, product labelling and regulatory guidance
- Liaises with publications and clinical development groups to develop and maintain timely and relevant product expertise
- Ensures the highest degree of quality and medical accuracy for all outputs developed
- Completes all work in accordance with regulatory requirements, industry standards, and argenx policies
Desired Skills and Experience
- Able to effectively network and partner with internal and external stakeholders and embrace cross-functional working
- Strong operational capabilities, eye for detail, and commitment to advance and adhere to processes
- Able to identify inquirer’s question(s) and formulate and communicate an accurate response
- Able to search the published medical literature, evaluate published scientific information and create balanced and informative responses
- Understand and demonstrate the importance of providing superior customer service to all clients to support the business
- Excellent communication skills: verbal, written and when giving presentations
- Able to thrive as part of a team and when working independently
- Proven track record of delivering results that meet or exceed targeted objectives
- Detailed understanding of industry regulations and practices relating to medical information
- Education, Experience and Qualifications:
- Bachelor’s Degree in related field or healthcare qualification e.g. RN, RPh, PharmD
- 1-3 years industry experience (can include Pharmaceutical Industry Fellowship experience); prior medical information experience is preferred
- Experience in componentized content creation is preferred
- Experience working with medical information vendors and call center management is preferred
- Experience in content management systems (Veeva Vault or similar) is preferred
- Experience in inquiry management systems is preferred
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