Job Description

社名
社名非公開

職種
臨床開発、CRA、CRC

業務内容
Lead impactful post-authorization studies and shape the future of patient safety in a dynamic, collaborative environment.■About the companyOur client is a leading global pharmaceutical company committed to developing innovative treatments and improving patient outcomes worldwide. They have a strong presence in Japan and foster a collaborative and supportive work environment.■Role & ResponsibilitiesYou will be responsible for the successful planning and execution of post-authorization regulatory commitment studies (PARCS), leveraging your expertise in project management and regulatory compliance. You'll collaborate extensively with cross-functional teams and external vendors, ensuring studies are conducted efficiently and adhere to the highest ethical and regulatory standards. This is an excellent opportunity to make a tangible difference in patient safety while advancing your career in a reputable pharmaceutical organization.■Main tasks include・Develop and execute project plans for PARCS, aligning with regulatory requirements and timelines.・Lead vendor selection and contract negotiations, ensuring optimal partnerships.・Manage project budgets effectively, monitoring expenditures and optimizing resource allocation.・Oversee regulatory processes and interactions with relevant authorities.・Prepare and present regular progress reports and final study deliverables to internal and external stakeholders.・Collaborate effectively with cross-functional teams, providing guidance and support to ensure projects meet milestones and objectives.If you are interested in this exciting opportunity, apply now.We look forward to hearing from you.#LI-Hybrid

求められる経験
■Requirements
・Bachelor's degree in Pharmacy, Medicine, Science, or a related field.
・Experience in project management within the pharmaceutical industry, ideally with a focus on regulatory compliance.
・Understanding of relevant regulatory guidelines such as GVP/GPSP and post-marketing surveillance (PMS).
・Proven ability to manage multiple projects simultaneously and meet deadlines.
・Excellent communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.
・Business-level English and Japanese language proficiency.

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収800 ～ 1,200万円

賞与
-
雇用期間
期間の定めなし

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