Senior Manager, Scientific Communications & Medical Education
Rezolute
Summary
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. The Senior Manager, Scientific Communications & Medical Education will develop and manage Rezolute's core scientific content and medical review activities for RZ358 across congenital and tumor HI.
Job description
Key Responsibilities
Scientific Content Development
- Develop and maintain standard response documents (SRDs), FAQs, and custom responses for RZ358.
- Coordinate development and updates of the SCP with the Medical Communications vendor and cross-functional teams.
- Develop and maintain MSL scientific slide decks aligned with the SCP and current clinical data.
Medical Information
- Manage in-house Medical Information, providing accurate, balanced responses to unsolicited inquiries from HCPs, patients, and caregivers.
- Partner with Medical Affairs Operations on Medical Information processes, vendor support, and inquiry tracking.
- Identify inquiry trends and share insights with Medical Affairs.
MLR Medical Review
- Serve as the Medical Affairs reviewer in MLR/PRC for promotional and non-promotional materials.
- Ensure scientific accuracy, fair balance, and appropriate referencing, consistent with the SCP.
Medical Education Grants
- Manage the medical education grant process, from request intake and review through approval, contracting, and reconciliation.
- Ensure grants are independent, compliant with ACCME standards and company policy, and tracked against budget.
Compliance & Governance
- Ensure activities adhere to Rezolute SOPs, regulatory standards, and industry codes of practice.
- Contribute to SOPs and work instructions for SRDs, Medical Information, and grants.
- Partner with pharmacovigilance on reporting of adverse events and product complaints received through Medical Information.
Required Qualifications
- PharmD, PhD, MD, or other advanced scientific degree.
- Hands-on experience developing SRDs and Medical Information responses.
- Experience serving as a Medical Affairs reviewer in MLR/PRC.
- Working knowledge of medical education grant processes, ACCME standards, and applicable industry codes and transparency requirements.
- Ability to translate complex scientific data into clear, accurate, and balanced content.
- Strong project management and attention to detail, with the ability to manage multiple deliverables and vendors.
- Strong communication and collaboration skills in a fast-paced, matrixed organization.
- Willingness to travel domestically (up to approximately 20%).
Preferred Experience and Attributes
- Minimum of 5 years of Medical Affairs experience in the biopharmaceutical industry, ideally in rare disease, endocrinology, or metabolic disease.
- Experience supporting rare disease or pediatric product launches.
- Experience with Veeva Vault PromoMats and Medical Information systems.
- Experience working with Medical Communications agencies and Medical Information vendors.
- High integrity, accountability, and commitment to Rezolute's mission.
Requirements
- PharmD, PhD, MD, or other advanced scientific degree
- Hands-on experience developing SRDs and Medical Information responses
- Experience serving as a Medical Affairs reviewer in MLR/PRC
- Working knowledge of medical education grant processes, ACCME standards, and applicable industry codes and transparency requirements
- Ability to translate complex scientific data into clear, accurate, and balanced content
- Strong project management and attention to detail
- Strong communication and collaboration skills in a fast-paced, matrixed organization
- Willingness to travel domestically (up to approximately 20%)
- Minimum of 5 years of Medical Affairs experience in the biopharmaceutical industry
- Experience supporting rare disease or pediatric product launches
- Experience with Veeva Vault PromoMats and Medical Information systems
- Experience working with Medical Communications agencies and Medical Information vendors
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Disability Insurance
- Life Insurance
- Long-Term Care Insurance
- Holiday Pay
- Free Vacation Program
- 401(k) Plan Match
- Educational Assistance
- Fitness Center Reimbursement
- Stock Options
Company overview
Rezolute is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for metabolic diseases, with a primary focus on diabetes and related disorders. The company leverages its proprietary technology platform to create novel drug candidates that address unmet medical needs in metabolic health. Rezolute's pipeline includes promising therapeutic candidates targeting various aspects of metabolic regulation, including glucose control and insulin sensitivity. Their research approach combines deep understanding of metabolic pathways with innovative drug design to develop treatments that could potentially transform patient care in diabetes management. The company operates at the intersection of biotechnology and metabolic medicine, advancing candidates through clinical development stages with the goal of bringing effective new treatments to market for patients suffering from metabolic disorders worldwide.