The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.

Company:

Veloxis Pharmaceuticals, Inc.

Job Description:

The Associate Director, US Medical Information and Capabilities is responsible for managing the medical information, investigator-initiated study, and grants capabilities within Medical Affairs leading the development and distribution of accurate, informative, and brand-aligned medical and scientific information for multiple products and therapeutic areas. This role oversees day-to-day implementation of the Medical Information and Capabilities strategy, ensuring timely and compliant delivery of evidence-based information to both internal and external stakeholders to support the safe and effective use of approved products and future therapies. The incumbent also leads growing Medical Affairs capabilities by serving as the operational coordinator for Investigator-Initiated Studies and educational grants as well as non-promotional MLR review. The incumbent contributes to effective Medical strategy by ensuring alignment with Company and Medical Affairs objectives and by supporting medical evidence generation, external stakeholder engagement, and medical communication efforts.

The base compensation range for this role is $165 - 180K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

Medical Information

• Creates comprehensive medical information strategy and leads implementation efforts for multiple products and therapeutic areas.
• Creates, reviews, and updates standard response documents, verbal response documents and FAQs.
• Maintains comprehensive knowledge database (Veeva MedComms) to house SRDs, FAQs, and other essential communications and informational documents.
• Responds to escalated medical information inquiries in a timely manner, resolving requests and ensuring cross functional communication with key internal stakeholders and subject matter experts, as necessary.
• Manages call center vendor, closely monitoring quality and effectiveness and providing training where necessary.
• Manages collection and reporting of adverse events and product complaints to the safety and quality teams while serving as Medical representatives on Safety Management Team.
• Oversees quality control to ensure all medical information activities comply with regulatory requirements, industry standards, and company policies, conducting regular audits and quality checks.
• Aggregates, analyzes, and creates monthly, quarterly and annual metrics reports for relevant stakeholders.
• Leads development of materials to support medical information booths for conferences, congresses, and other events.

Medical Capabilities

• Provides operational oversight for Investigator-initiated Studies and educational grants, including review committee management, contracting, and detailed project tracking.
• Maintains Medical reference library and transfer of value reporting.
• Optimizes Veeva MedComms utilization for review processes, resource management, and usage tracking.
• Contributes to Medical strategic planning and coordinates reporting activities including annual brand planning, mid-term planning, and monthly business reporting.
• Leads Medical Affairs departmental engagement initiatives including departmental meetings and team building activities.
• Oversees Medical Affairs contracting progress by leading routine legal and compliance contract management meetings.
• Serves as MLR coordinator for non-promotional review, including organizing committee meetings, review cycles, and Veeva processes.

Functional Competencies

• Supports Medical and scientific engagement, presentations, and data exchange through ongoing dialogue with and support to the Field Medical team.
• Maintains scientific knowledge in relevant disease states by staying up to date on scientific publications and competitive landscape.
• Manages vendor relationships, including performance, quality, and budget oversight.
• Identifies opportunities to use emerging technologies to improve Medical effectiveness.

• Advanced degree in life sciences, pharmacy, or related field.
• Nephrology and/or transplant experience, strongly preferred.
• Minimum of 5 years’ experience in Medical Affairs.
• Strong understanding of medical information and medical content development processes.
• In-depth knowledge of Veeva MedComms utilization.
• Experience managing Investigator-Initiated Studies.
• Strong understanding of Medical Affairs operations.
• Excellent organizational and project management skills, with the ability to manage multiple priorities and deadlines.
• Excellent interpersonal and communication skills, both oral and written, with the ability to influence and collaborate effectively.
• Proven ability to work collaboratively with cross-functional teams and stakeholders.
• In-depth knowledge of the pharmaceutical industry, including the regulatory and compliance landscape.

Travel Requirements: 15-20%

#LI-AS1 #Hybrid

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.