Medical Research Manager

Job Responsibilities: • Contribute to therapeutic area and clinical development strategy within Evive portfolio. • Direct the creation of clinical development plan to translate the overall strategy into an executable plan. • Accountable for providing medical oversight Ｏn clinical trials and ensure that all studies meet regulatory requirements and are compliant with all policies, SOPs and GCP guidelines. • Provide medical and scientific expertise Ｏn medical project and communicate with study teams and key stakeholders internally and/or externally. • Accountable for generating or review clinical documents such as CDP, protocols, IB, CRF, CSR, SAP, etc. • Provide medical review and approval of clinical documents for regulatory submissions, i.e. Pre-IND briefing documents, IND and NDA submission, annual reports, etc. • Establish and foster strong professional relationships with KOLs, study investigators, academic scientists, and consultants mainly in US. • Provide medical assessment of in- and out-licensing opportunities of development projects. Qualifications: • Medical doctorate degree or equivalent degree is required. Subspecialty training and advanced knowledge in a medical area (for example internal medicine) is strongly preferred. • 1-2 years of clinical research or drug development experience working in a pharmaceutical/biotech company. • Strategic thinking and highly effective analytic skills. • Must have excellent communication, influencing and presentation skills (verbal and written). • Excels in organizational agility and cross-functional approach.

唐经理 人事部 聊一聊

最近在线时间：2022-05-22 22:05

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地址：新泽西州

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