Medical Manager 医学经理
主要职责:

Maintain scientific and clinical knowledge in the specific therapeutic and disease areas 

Contribute to the clinical development strategy for the relevant therapeutic/disease areas

Conduct literature searches and analyze the data and information necessary to create the clinical development plan

Provide medical support for clinical trials:

Develop clinical study design for internal reviews 

Provide support to clinical operation and other groups to develop Informed Consent

Form (ICF), Case Report Form (CRF), CRF instructions, etc

Review and/or write additional clinical science documentation and/or provide clinical science input into other documentation managed by other groups

Collaborate with data management and other groups to conduct medical review of study data, identify and evaluate the data outliers and query the sites

Collaborate clinical operation and other groups to identify and evaluate the protocol deviations

Assist medical director to review the study report and respond to authority’s inquiries

Prepare or review abstracts, posters, and content for scientific events etc.

Collaborate with regulatory and other team to complete and submit regulatory filings and other regulatory documentation.

Collaborate with PV to review safety data and provide medical support and judgement to ensure the high standards of clinical safety

Provide medical support to Commercial, Market Access, Regulatory, Pharmacovigilance, and Legal Counsel

Provide initial and ongoing medical trainings to MSLs and commercial team and in collaboration with MSL to provide training to external staff

Review training documents and other promotional or non-promotional materials to ensure medical accuracy and compliance with regulatory requirements


任职要求:

 Masters Degree in life sciences required. The experience in oncology, hematology or with a broad medical background is preferred

 Minimal 3 years in clinical practice, pharmaceutical medical affairs or clinical development

 Able to work within matrix organization and provide leadership

 Design and implement clinical trials

 Disease area knowledge, including key scientific publications

 Well-versed in medical aspects of GCP, ICH, CFDA

 Good scientific thinking, agility in learning and good communication skills

 Good computer skills (Word, PowerPoint and Excel skills)


招聘人数:1
联系方式:
hr_recruitment@fosunkitebio.com