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.

Job Purpose

The Senior Director, CNS Medical Affairs leads, manages andsupports all aspects of Medical Affairs strategy for the CNS business unit. Serves as an integral member of internal cross-functional teams and as the principal contact with internal/external stakeholders with respect to CNS Medical Affairs strategy, Medical Information, Medical Training, and Scientific Publications.

Key Responsibilities:

• Drive US CNS Medical Affairs Strategy aligned with company strategic imperatives
• Lead the development of strategic and tactical publication plans for Kyowa Kirin marketed and late stage pipeline CNS products.
• Drive the delivery and implementation of publication plans to ensure high-quality strategic publication deliverables.

• Direct, design and coordinate secondary data generation activities to support strategic publication objectives.

• Support CNS medical affairs training function. This includes collaborating on the development and dissemination of CNS medical affairs training plan, materials, and certifications.
• Collaborate with commercial sales training to provide medical feedback on the development and dissemination of training materials. Serve as principal medical affairs representative on CNS commercial training activities.
• Direct development and dissemination of medical information materials and vendor training including medical information letters and FAQ documents for Kyowa Kirin marketed and late stage pipeline CNS products.
• In collaboration with MSLs, initiates, expands and maintains peer-to-peer KOL relationships
• Collaborate with the VP of Medical Affairs on CNS aspects of US Medical Affairs function.
• Represent Medical Affairs and contribute to launch readiness activities including labeling, life cycle management, and other early commercialization initiatives for late stage CNS pipeline products.
• Prepare and manage publication and medical information budget for assigned products, collaborate with Finance to coordinate the processing and reporting of project spend.
• Oversee vendor-related activities (selection, contracting, onboarding, day-to-day operation, performance evaluation and improvement).
• Represent US Medical Affairs function in as needed cross-functional project teams and brand teams, and provide input into relevant processes

• Represent US CNS Medical Affairs function in as needed basis for key external stakeholders, e.g. guidelines committees, payer groups, professional organizations, patient advocacy organizations.
• Represent CNS Medical Affairs on PRC/ MRC Review Team
• Ensure adherence to all applicable SOPs, policies, processes, and compliance guidelines.
• Additional projects and assignments as needed

Position Requirements

• Advanced degree in Health Sciences or related fields (MD, PhD, PharmD). 
• CNS experience preferred.
• Minimum of 5 years of industry experience in Commercialization strategy, Publications, Medical Affairs, or Medical Communications at pharmaceutical companies or medical communication agencies. 
• Direct experience in medical information, publication planning and publication content preparation is highly preferred.
• Deep understanding of pharmaceutical R&D and commercialization processes.
• Direct experience in development and presentation/training of medical materials to medical and non-medical audiences
• Good knowledge of principles and practices of pharmaceutical clinical studies (including design, conduct, analysis and reporting). 
• Fluency in Good Publication Practice, ICMJE guidelines and other applicable industry guidelines. 
• Strong analytical skills, attention to details, and ability to manage/prioritize multiple projects from conception to completion in a fast-paced environment. 
• Demonstrated 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
• Must possess Integrity and be innovative in how they work on a day by day basis.

Physical Requirements: (travel, lifting, typing, driving, sitting, special requirements around hours etc)

• Must be able to travel domestically and internationally 10-20% of the time.

If applicable to the role, outline the power granted or delegated to the role. For example power to release/recall products.

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 kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. 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 usprivacyoffice@kyowakirin.com.

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