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The PositionPosition title: Medical Affairs Expert
Working Location: Shanghai
This role supports the development and implementation of medical strategies for assigned therapeutic areas, working to align them with business objectives and organizational priorities. The position collaborates with cross-functional teams and external experts to assist in evidence generation, medical evidence dissemination, and insight gathering. The candidate should have a solid medical/scientific background, the ability to work effectively across departments, and an understanding of clinical needs in the diagnostic field. Maintaining compliance with relevant regulations and company policies is an essential aspect of the role.
Your Opportunity:
Collaborate with the Medical Affairs Lead to develop medical objectives and strategies aligned with development requirements and formulate corresponding implementation plans. Align with relevant BAs on medical strategies, and ensure effective follow-up on plan executionThrough close collaboration with investigators, medical science teams, evidence generation units, and business partners, ensure adherence to clinical trial regulations, lead clinical evidence collation and study protocol development, and demonstrate proficiency in the R&D lifecycleBuild and manage KOL networks, leveraging evidence-based medicine and competitive intelligence to facilitate high level scientific exchanges and capture actionable insights. Effectively communicating with stakeholders by deliver high-quality medical training programsIntegrate clinical evidence to support medical decision-making and clinical needs input for new product launches and indication expansion evaluations. Deliver compliant responses to unsolicited inquiries regarding unapproved indications or off-label usageProactively engage with KOLs to deliver the latest medical and scientific advancements in relevant disease areas, while identifying their perspectives and needs. Support commercial teams in discerning the underlying requirements of experts and implementing appropriate interventionsReview corresponding event applications to make sure compliance with Dia Symphony and related SOP’s, Good Clinical Practice (GCP) and HCP guidelines; Review HCP PPTs and Roche promotion materials to ensure no off-label promotion.Review speaker pool registration applications and speaker engagement applications to make sure that all the speakers are qualified and medical contents in the speaker PPTs are accurate, fair, balance, evidence-based and compliance with local regulationsConduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection. Understand and fulfill the responsibility of line manager's SHE tasks and duties (as defined in SHE handbook)Other projects or tasks assigned by line managerWho you are:
Doctoral or master’s degree in medicine, biomedical Sciences, or Pharmaceutical Sciences, coupled with hands-on expertise in relevant disease area5+ years of experience in developing and implementing medical strategies for various diseases in the medical or pharmaceutical industryClinical research and trial management experience and the ability to interact with KOLs with sufficient knowledge, expertise, and confidence.Diverse experience across multiple medical affairs/development leadership roles (field, strategy, medical or clinical operations, development) strongly preferredDemonstrate Roche values of Integrity, courage, and passion.Follow Roche Operating PrinciplesEquip with the core skill sets as required by this roleWho we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.