Associate Director/ Director, Global Medical Affairs Excellence (GMAE) Operations

Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes three offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

As a patient centric organization that strives to deliver innovative medicines to meet unmet needs, we feel that it is critical to follow the safety guidelines defined by CDC and OSHA. We believe the COVID-19 vaccine is the best way to manage COVID risk to you, your colleagues, your family and our society. With that in mind, we are taking the essential step to ensure the safety of our employees during this health crisis by requiring all US employees, temporary workers, agency employees and independent contractors to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. In accordance with applicable law, individuals may seek an accommodation for medical or disability-related conditions or sincerely held religious beliefs.

Summary of Job:

This role will be responsible for driving operational excellence for Global Medical Affairs activities by contributing to global plans design/execution, policies and capabilities while coordinating across regions for analytics/ insights/ KPI monitoring, data stewardship and governance, HCP data owner, process optimization SME, Medical Information, and other projects within GMAE. 

Essential Functions:

• Medical Affairs Excellence
• Support the Global Business Platform, technology innovation and operational excellence for assigned Global Medical Affairs projects and work streams.
• Leads the development, implementation, and oversight of technology, resources, and processes, in relation to Global Business Platform and provide infrastructure and general support to globally.
• Support the development, tracking, analysis, and reporting of metrics and KPIs to evaluate the success of the Global Medical Affairs activities
• Lead the development and execution of appropriate communication and training for available tools and business solutions to internal and external stakeholders.
• Facilitate and actively promote sharing of best practices, solution mindset to help for continuous improvement
• Develop and support training and communication plans that support data & digital programs
• Lead assigned GMAE Global Business Platform projects through all phases (conception, initiation, drive, implement and deliver) within budget, timelines, and quality) for deployment
• Responsibility for data stewardship and governance
• Handles planning program life cycle management and enhancements to new and existing digital programs; working independently and collaborating across divisions and functions representing medical with IT, vendors, compliance, and variety of stakeholders and partners.

• Medical Information
• Develop and deploy digital/online resources that enable real-time/just-in-time engagement.
• Manage alignment with collaboration partner for Medical Information processes.
• Responsible for the development/enhancement and implementation of policies, procedures, and processes for Global Medical Information.
• Responsible for implementing policies, procedures, and platforms that ensure prompt and accurate responses to medical information requests.
• Develop KPIs for key business processes to monitor Medical Information services, including audit readiness and other quality control systems.

Job Requirements:

Education

• Advanced clinical and scientific training/experience required equivalent to PharmD, PhD, MD, or other advanced degree.

Experience

• 5+ years of Medical Affairs Experience
• Medical Information experience preferred
• Experience evaluating and managing vendors and strategic partners.
• Experience with data management, analytics and informatics.

Technical Skills

Proficient in MS Office Suite.

Non-Technical Skills

• Strong analytical skills, attention to details, and ability to manage/prioritize multiple projects from conception to completion in a fast-paced environment
• Ability to address pertinent business matters and independently oversea customer recovery strategies
• Strong written and oral communication skills. 
• Ability to work well in cross-functional teams (across geography and culture) with a group of people with diverse skill sets and personalities. Team player, flexible and adaptable. Ability to build good working relationships, both inside and outside the organization.
• Self starter
• Ability to work strategically and collaboratively globally across departments and senior leadership
• Ability to collaborate across regional, field and HQ functions seamlessly
• Must possess integrity and be innovative in how they work on a day by day basis.
• Ability to work outside of normal business hours due to global nature of the role

Physical Demands:

• Flexibility in working hours to accommodate travel and meetings. 
• Sitting at workstation.
• Remote position 

Working Conditions:

Requires up to 10-20% domestic and international travel 

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 135 Route 202/206, Suite 6, Bedminster, NJ 07921 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected]. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at [email protected].

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