Argenx
Senior Manager Medical Information - Content Management
Argenx, Boston, Massachusetts, us, 02298
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan, and Switzerland.
To be considered for an interview, please make sure your application is full in line with the job specs as found below.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.Roles and 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
Responsible for the creation of prompt and accurate responses to MI requests from internal and external customers through the MI Response Center, email, fax, and websites
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 Competencies: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
#LI-HybridJoin us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.PDN-9c7e5b85-e219-48ae-83df-76b9a6b2bcd5
To be considered for an interview, please make sure your application is full in line with the job specs as found below.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.Roles and 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
Responsible for the creation of prompt and accurate responses to MI requests from internal and external customers through the MI Response Center, email, fax, and websites
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 Competencies: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
#LI-HybridJoin us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.PDN-9c7e5b85-e219-48ae-83df-76b9a6b2bcd5