Medical Manager Lead-Lupus
Biogen 查看所有职位
- 上海市
- 长期
- 全职
- Establish and maintain trusted relationships with Key Medical Experts (KMEs), investigators, and other stakeholders through scientific exchange as appropriate. In line with local requirements and regulations, this may include reactive focused communication and education for Biogen´s development products.
- Act as a credible and valued SME & partner in the medical community (e.g. medical experts, research forums) and gather insights to inform pipeline strategy through legitimate exchange of medical and scientific information during the development of a medicine.
- Coordinate and consolidate analysis and selection to define the KME universe for the country to identify and prioritize key experts for strategic engagement. Develop and execute KMEs engagement plan to support peri/pre launch readiness activities.
- Develop industry leading National Medical Strategies for targeted area therapy
- Execute Medical activities with good quality based on approved medical strategies
- Develop medical materials with good quality for external scientific meetings
- Disseminate high quality complex scientific information and provide innovative medical education content which can accurately match HCPs’ confusion
- Contribute to the development & execution of regional and local medical strategies for pipeline products by creating tactical medical plans, mapping KMEs, and supporting reimbursement dossiers.
- In line with the country strategy , manage early access programs in alignment with Regulatory Affairs and global stakeholders.
- Align medical activities with brand objectives to prepare the market for future product launches.
- Liase with PAG responsible in case it is needed
- Provide technical and educational support to internal local teams (e.g. Medical Affairs Drug Safety, Medical Information, Value & Market Access, Regulatory Affairs, Commercial) and healthcare professionals on Biogen’s disease areas and pipeline products, including speaker support, internal training and congress participation to ensure accurate and compliant dissemination of scientific knowledge.
- Manage disease awareness projects in alignment with medical strategy and brand plans.
- Support Global clinical trial activities, including site initiation and coordination in alignment with CCL;support Phase IV studies, and registries set up to facilitate high-quality data generation and contribution to lifecycle management.
- Identify appropriate study centers for future global studies including serving as point of contact for country/site questions relating to study operational issues;
- Partner with appropriate study team members and CCSL for global studies, as needed; influence country selection and/or lead site selection with coordinated input from appropriate stakeholders - as appropriate - for phase I-IV studies; support review of study documents, including site visit reports and/or ICFs for global & local studies as needed.
- Support data generation efforts by contributing to registry setup and evidence generation partnership with KMEs to strengthen the evidence base for reimbursement.
- Collaborate with International and global teams for planning, managing new studies and compassionate uses at local level.
- Review scientific materials for accuracy and ensure compliance with local regulations to promote informed clinical decision-making and maintain Biogen’s ethical standards in medical communications.
- Ensure accuracy of scientific responses to medical questions from HCPs and patients according to local law and internal regulations.
- Mentor new colleagues and promote best-practice sharing to strengthen team capabilities and ensure high-quality medical engagement.
- Support on the training and medical information activities for the field force
- A medical degree (e.g., MD) or a natural science degree is required. An advanced terminal degree is preferred, such as MD, PhD, or PharmD.
- Candidates may also qualify with an equivalent combination of education and experience in relevant medical or scientific fields.
- 7–10 years of relevant experience in the pharmaceutical industry, particularly in Medical Affairs or Clinical Research,
- Fluency in English
- Ideally, Medical/scientific expertise in Neurology and Immunology, working knowledge of Regulatory Affairs, Drug Safety, Legal, and Compliance and basic knowledge of Health Economics
- Knowledge of clinical operations and conduct of clinical trials would be an advantage.