Associate, Clinical Supply Management

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 disease areas : bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

The Associate, Clinical Supply Management collaborates with multi-disciplinary teams to support the execution of activities necessary for the production of clinical trial study supplies. This role is responsible for facilitating the supply and distribution of investigational products (IP) to investigators, working closely with both internal and external customers and suppliers to achieve project objectives. The Associate will assist Clinical Supply Managers in ensuring that vendors adhere to distribution and return drug plans, coordinating packaging and labeling, monitoring inventory levels, and providing feedback on expiry and re-supply requirements.

Key Responsibilities :

• Assist in the maintenance and coordination of the drug reconciliation process including review and approval of drug reconciliation records across clinical studies working directly with functional representatives (e.g. Clinical, Quality Assurance, etc.) as needed.
• Support supply planning and forecasting activities.
• Interpret protocol information to assist in developing packaging / labeling design and distribution strategies.
• Assist in the origination, proofing and translation of clinical study labels as required.
• Manage temperature excursions affecting clinical trial materials, ensuring proper documentation and resolution.
• Support with the review of IP documents, electronic document archiving and quality control.
• Track drug supply at the CMO and clinical sites, maintaining accurate inventory records for IP throughout the life of the trial to avoid supply issues
• Monitor and track the retesting and updating of clinical trial materials.
• Develop templates and SOPs to support the management of IP processes.
• Assist Clinical supplies team with special projects and study related activities as assigned.
• Coordinate and assist in Clinical Supply meetings.
• Maintain close communication with internal study teams to ensure study timelines are met.
• Cultivate a strong working relationship with Quality Assurance for timely review and approval of study documents.

Job Requirements : Education

Bachelor's degree in Life Sciences, Supply Chain Management, or closely related discipline

Experience

Minimum one (1) year of experience in clinical supplies management or a related field, preferably in a pharmaceutical or biotechnology environment.

Technical Skills

Non-Technical Skills

Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.

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 510 Carnegie Center Dr. Princeton, NJ 08540 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 .

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.