Medical Enabler at Roche

The Position

• Roche in Midrand is seeking a Medical Enabler. The Medical Enabler is a therapeutic / disease area expert and supports the Primary Point of Contact (PPOC) in the relevant therapeutic area (TA). The Medical Enabler Role ensures both medical/scientific expertise independent from promotional objectives in all their decisions.
• The Medical Enabler works with the PPOC to gain a deep understanding of the relevant patient journey and area ecosystem needs. They collaborate and derive actionable insights that inform the Therapeutic Area strategy. They proactively enable co-creation and delivery of national-level activities that deliver tangible value to the medical community and transform clinical practice.
• The Medical enabler develops broad medical & scientific expertise, often across multiple molecules or indications within a given Therapeutic Area, and drives evidence generation and scientific exchange activities. This is a network role that fosters and enhances collaboration and coordination across the formal and informal network - in country , across countries or as seen relevant to serve patients across the enterprise. The role is anticipated to spend most of its time serving the local ecosystems.
• They remain focused on supporting high-value and high-impact activities that either directly, or indirectly, touch the patient journey.
• The Medical Enabler is a fluid member of one or more Therapeutic Area aligned working teams according to evolving needs. Together with the PPOCs they maintain strong relationships with TAEs and partner with them on national-level initiatives as appropriate.

Cross-Functional responsibilities

• PPOC’s (HSP/PJP’s) are the custodian’s and responsible for external stakeholder engagement, acting as the product owners for work packages identified and delivering solutions in response to ecosystem needs.
• Contribute to and drive solutions for work packages generated, these may be ecosystem related, internally generated or relate to foundational / License to Operate procedure’s, amongst others

Disease Area Accountabilities

• Deep disease area expertise: Custodian of assigned TA data, ensure credible scientific communication dissemination, fostering Roche‘s reputation as a science-based, innovative and patient-focused reliable partner
• Support development and execution of patient-focused medical strategies that supports the maximization of the value proposition of assigned Roche therapies including support of strategic planning, launch support by participating in Launch pods and lifecycle management, in collaboration with appropriate cross-functional teams and governance, in full compliance of all laws, regulations and SOPs as a part of the organizational responsibility
• Determine scientific/medical subject matter appropriateness of labels/regulatory/patient access/promotional material and medical deliverables used to support internal/external interactions through appropriate review process as per SOP’s
• Provide valuable insights and solutions and be a thought partner for scientific engagement across a broad range of stakeholders to strengthen external understanding of the unmet need and value of the product as a part of the patient Journey solution, including medical specific training where appropriate
• Support PPOC relationships with the external healthcare community, including interactions with Top TAEs, payers and societies for scientific exchange, where appropriate and contributing to medical activities & solutions
• In response to the ecosystem, develop and lead evidence generation projects (clinical protocols, RWE, digital, registries), applied cross-functionally with the PPOC (HSP/PJP) responsible for customer engagement & delivery of solutions
• Respond to unsolicited queries for the assigned Therapeutic areas from HCPs in accordance to local laws, regulations and codes and Roche SOPs, facilitate their needs of up to date scientific data
• Support the Regulatory Teams by providing medical expertise for New Product / Indications dossier review, Submission Preparation and presentation support to Global Team and Local RA from medical aspects. Review and approval of Prescribing information and Abridged prescribing information for the assigned Brands
• Clinical Operations Team Support - Facilitates Investigator Initiated Studies through review of Study materials. Support for initial investigator /site mapping for the PDMA studies. Scientific responsible for clinical studies in the affiliate
• Manage evaluation of patient eligibility and all the procedures to the treatment approach for Compassionate Usage (CU) program's. Review of case details on PAIRS system and coordination with the treating Physicians as appropriate
• To provide inputs into outcomes based planning ensuring that key priorities and value add activities in the ecosystem are addressed. Leverage Global network for solutions and best practices by participating in Community of interest / CoP and be Global point of contact for the assigned Therapeutic Areas
• Provide input on IME, medical grants and sponsorships, where appropriate

Eligibility Criteria:

• Medical degree, PhD/PharmD/Masters in Science (MSc) degrees would be an advantage
• NQF 8-10 in health sciences related field
• 3-5 years pharma experience Preferable
• Established knowledge base/ skill set in: Data generation (clinical trials; IIS, RWE programs)
• Understanding of clinical trial design, interpretation and biostatistics

Skills Required:

• Self-managed and self-directed;
• Display of integrity in everything;
• Excellent stakeholder engagement, influencing and networking skills
• Proved experience in working in a cross-functional team;
• Experience in agile ways of working;
• Broad understanding of Roche’s present portfolio and future pipeline;
• Robust understanding of medical affairs strategies and tactics including clinical research
• RWD / RWE Capabilities
• An understanding of Digital Transformation in Medical Affairs to support the Affiliate and Network