Medical and License to Operate Intern

Job Description

With the purpose of developing the skills and capabilities of talented fresh graduates for future strategic positions within our organization, Roche Pars is launching an Early in Career Program. The program consists of 6 to 12 months of experience across key areas of our business. The selected young talent will be developed through the project and activity-based experiences that support and are tailored to the needs of each of our functional areas. ● You will gain experience within the Medical and License to Operate Chapter through field medical teams and gain exposure to medical and regulatory and quality excellence to focus on career development. ● The project will involve cross-functional collaboration with different chapters within Roche Pars. ● 6-12 months contractor, entry-level. ● Renewal pending feedback and assessment. ● No job or HC guarantee. Would you like to play an active role in doing now what our patients need next? Medical Procedure: ● Assist the Medical department in identifying the unmet medical needs in various Therapeutic Areas including Oncology, Neuroscience, Hemophilia, etc., treatment pathways, data gaps, and stakeholder mapping (external events/patient organizations) for upcoming indications and pipeline assets of Roche Pars products. ● Learning about and working on projects involving the medical expert role, medical Insights analysis, data dissemination, clinical education tools, and advisory board support. ● Work collaboratively with License to Operate on document internal regulatory processes, such as internal audits, inspections, license renewals, preparation of regulatory documents, and technical files for submissions or registrations. May compile and prepare materials for submission to regulatory agencies. ● Prepare or direct the preparation of additional information or responses as requested by regulatory and medical partners. Regulatory Procedure: ● Manage internal partnerships with the key cross-functional team. ● Collaborate closely with regulatory, safety, and quality partners to drive LTO operational tasks. ● Support the submission management process of new drug and renewal applications. ● Support updating the regulatory database to reflect the latest status across the Roche system. ● Support creating/updating regulatory plans for the new and post-approval submissions. ● Assist in regulatory archiving of physical and electronic documents.