• Develop clinical knowledge expertise in the Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) treatment landscape including current treatment strategies.
• Develop and ensure alignment in medical education activities for healthcare professionals and payor organizations through MSL-delivered presentations, participation in medical meetings and other appropriate venues to enhance product and disease state knowledge. 
• Establish and maintain scientific/professional relationships with formulary decision makers, external thought leaders and payer influencers by addressing unsolicited requests for information, providing disease awareness and pharmacoeconomic information, and ensuring a clear understanding of the balanced scientific, clinical, safety and pharmacoeconomic data related to Rayaldee.
• Provide educational presentations and training as required on Managed Care issues to internal and external colleagues.
• Ensure alignment on content of effective clinical presentations provided to internal and external audiences, ensuring presentations are tailored to meet the specific needs of the audience (including appropriate responses to unsolicited requests).
• Ensure efficient information exchange between MSPVL colleagues in the field and office-based clinical, medical affairs and drug safety team members so that key clinical, safety and research issues are identified and communicated to and from industry leaders and the appropriate OPKO departments to help shape company research and development strategies for investigational and commercialized products.
• Identify educational needs within the medical community around CKD-MBD disease state management.
• Maintain clinical expertise through comprehensive education including attendance at relevant scientific symposia and workshops, and review of key journals; and where applicable participation in required internal training, and presentations.

• Adhere to all regulatory and compliance guidelines and company policies in all aspects of scientific dissemination of information, including responses to unsolicited requests for medical information. 
• Intake and triage and follow-up of safety information from all sources (e.g., subjects, patients, healthcare professionals, pharmacies, sales representatives, general public). 
• Completion of cases in a timely manner in accordance with appropriate protocols and regulatory guidelines.
• Ensure compliance with health authority regulations in drug safety data processing and reporting.
• Enter and track safety information in safety databases.
• Code medical terms using standardized medical dictionaries (e.g., MedDRA and WHO Drug); assist with establishing coding conventions.
• Participate in the review and reconciliation of data between safety databases and data migration activities.
• Coordinate database implementation and validation.
• Review product complaints and assess for potential adverse events or any impact on subject safety. 
• Perform literature review activities related to adverse event reporting. 
• Provide information and assistance to medical/drug information staff (internal and/or external) as needed.
• Coordinate and ensure appropriate case investigation to gather all required medical information, including query generation, tracking, and follow up with reporters (research and post-market).
• Liaise with clinical operations, medical/drug information, regulatory affairs, clinical research organizations (CRO), study sites, affiliates and data management groups regarding safety data collection and data reconciliation as required. 
• Ensure compliance with Safety Data Exchange Agreements or Pharmacovigilance Agreements to include (not limited to) exchange of individual case safety reports (ICSRs) and periodic reconciliation of safety data.
• Oversite of clinical research organizations (CRO) involved in clinical trials performing PV activities.
• Additional responsibilities & projects as assigned.

QUALIFICATIONS

• MD, PharmD, PhD, RN or other allied medical degree preferred and 5-7 years’ experience, or comparable experience.
• Knowledge and experience in the field of nephrology, especially in CKD-MBD preferred.
• Demonstrated ability to work collaboratively with relevant internal stakeholders and to lead projects and work in cross functional teams.
• Excellent leadership, management and negotiation skills. 
• Ability to work in a fast-paced, highly visible and dynamic environment is critical.
• Ability to influence and work effectively across functions and operate in a matrix environment.
• Willingness to travel, when needed.

• No relocation required (remote- home-office based). 

SKILLS

• Expertise in therapeutic areas of CKD-MBD with particular emphasis on payor landscape.
• Developed expertise in the safety and efficacy data from the Rayaldee clinical and non-clinical development program.
• Ability to participate in one or a combination of the following cross-functional project teams, to be determined by business need, available resources and personal career growth objectives:
  • Scientific and Medical Associations Outreach, Engagement and Partnerships
  • Thought (KOL) and Payor Opinion Leader (POL) Identification, Mapping and Engagement
  • Medical Education
  • Pharmacovigilance

• Excellent communication skills, both written and oral, and completely familiar with the effective use of MS Outlook, PowerPoint, Word and Excel.
• An ability to build strong relationships and influence medical professionals in both academic and community-based practice settings.