Medical Informationist (Digital Health)

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The Position

The Opportunity:

The Medical Informationist serves as the subject matter expert on clinical evidence and medical content within the Digital Health Product Team. This role is responsible for ensuring the scientific and medical integrity of the product features user-facing health information and underlying clinical logic supporting both regulatory compliance and optimal user experience.

You will:

1. Clinical Innovation and Evidence-Based Product Development

• Clinical Gap Analysis: Leverage in-depth clinical knowledge to identify inefficiencies challenges or gaps in existing clinical workflows and patient care pathways.

• Clinical Solution Design: Co-create and design innovative clinical care models procedures and technologies in collaboration with BA colleagues and hospital clinicians. This includes collaborating with KOLs and product managers to translate complex clinical pathways and medical standards into digital product logic (e.g. for AI/ML features or clinical decision support).Act as the primary medical and scientific point-of-contact for the Product Manager UX Designers and Engineering team.

• Evidence-Based Development: Inform the development of all new product features (e.g. symptom checkers personalized health recommendations) by conducting comprehensive systematic reviews of biomedical literature clinical guidelines and regulatory data.

• Clinical Validation:Partner with data scientists to test and validate hypotheses through evidence-based practices (such as real-world data) and drive the evaluation and clinical validation of experiments and prototypes.

• Medical Content Integrity: Write review and validate all health-related content presented to end-users (patients and providers) to ensure it meets the highest standards of scientific accuracy balance and non-promotional language.

• Cross-Functional Liaison: Act as a key liaison between clinical teams product teams and research teams to align innovation projects and ensure medical integrity is maintained throughout the product life cycle.

2.. Product Development Collaboration (Embedded Role)

• User Research Support: Provide clinical expertise during user research (e.g. with physicians and patients) to ensure research questions and findings accurately reflect clinical workflow and user pain points.

• Feature Specification: Help the Product Owner write detailed medically sound user stories and acceptance criteria for all clinical features.

3. Regulatory and Compliance Support

• Compliance Documentation: Assist the Regulatory and Quality teams in documenting the medical basis and supporting evidence for product claims and functions especially for Software as a Medical Device (SaMD) classifications.

• Risk Mitigation: Identify and assess potential clinical risks associated with product functionality or displayed information working with the Risk Management team to define mitigation strategies.

• Post-Market Surveillance: Monitor and analyze user feedback and medical information inquiries to identify potential safety signals or needs for clinical updates within the product.

4. Knowledge Management & Training

• Resource Curation: Develop and maintain an accessible internal database of key medical literature clinical trials and foundational disease-state knowledge used by the product team.

• Internal Training: Educate non-clinical team members (Designers Engineers Marketers) on complex medical topics clinical workflows and the importance of regulatory compliance.

Who you are:

• Required: Advanced Degree in a Health Science field (Pharm.D. Ph.D. in Life Sciences M.D. or in Clinical/Health Informatics).

• Expertise in Evidence-Based Medicine and critical appraisal of scientific literature. Deep understanding of regulatory environments (e.g. FDA EMA) as it relates to medical information.

• Proficiency in medical search databases (e.g. PubMed Embase Cochrane). Familiarity with clinical data standards (e.g. HL7 FHIR SNOMED CT).

• Exceptional written and oral communication skills especially the ability to synthesize complex data for diverse audiences (clinical technical layperson). Strong collaborative and cross-functional teamwork abilities.

• 5 years of experience in Medical Affairs Medical Information Scientific Communications or Clinical Informatics preferably in a pharmaceutical medical device or health technology setting.

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.