j******8
发帖数: 12 | 1 地点：上海；要求：CNS相关专业，临床医生背景；项目类别：AP（新药3期）
Basic Function:
Provides medical input to all areas of clinical development projects
related to CNS in AP including the Product Development Plan (PDP), Study
Protocols, case report forms (CRF), data evaluation, clinical study report,
publications, NDA submission and response to regulatory enquiries. Ensures
that all documents are developed with sound, valid clinical judgment in a
timely manner Represents PDCC-M in the Local or International Project Team (
IPT) as core member
Primary Responsibilities include:
Drafts clinical development plan with the support from
clinical project team.
Assesses the global study feasibility, designs and writes
local or regional clinical study protocols, assures protocols will adhere to
standard clinical practices, and develops the case report form with data
management team.
Builds strong relationship with KOLs and maintains the
contact, selects suitable clinical consultants for clinical trials or
therapeutic area
Works with operation team to resolve the issues during the
study conduction, monitors patients safety in the ongoing clinical studies
Secures the conditions essential for safety, efficacy and
medical usefulness of a drug
Works closely with biostatistics and decides how the
resulting data should be analyzed.
Preparation of abstracts, posters and publications
Represents PDYC in the local and global project teams as
core member
Drafts clinical study report, NDA submission and response
to regulatory enquiries.
You’re someone who wants to influence your own development
. You’re looking for a company where you have the opportunity to pursue
your interests across functions and geographies, and where a job title is
not considered the final definition of who you are, but the starting point.
Qualification and Experience:
M.D. degree with specialty training in neurology/psychiatry
/neuroscience, he/she should have soundable medical knowledge in this
therapeutic area.
More than 2 years in clinical practice in CNS department,
and has the experience taking caring Psyche patients
At least 2-3 years clinical research experience in
pharmaceutical industry or academic institute specifically in the neurology
therapeutic area (focus on study design).
Excellent communication and influence skill with different
stakeholders (Chinese and English)
Established relationship with Key Opinion Leaders &
Investigators, especially for renal and metabolic diseases (at least a brief
name list)
Excellent ability of innovation, independent leading and
strategic thinking (at least a real case to demonstrate)
Excellent ability of project execution (at least a deep
understanding of execution)
Jane Lee 李艳
HR Consultant
GEN Enterprise Management Consulting Co., Ltd.
Tel：+86 21 5155 8084 Email：j****[email protected] | j******8
发帖数: 12 | 2 看在我翻墙不易的份上，同胞们多捧捧场HA^_^
职位紧急，1周之内给反馈~ | t**n
发帖数: 4365 | 3 MD做clinical development的愿意回国的多吗？
,
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【在 j******8 的大作中提到】
: 地点：上海；要求：CNS相关专业，临床医生背景；项目类别：AP（新药3期）
: Basic Function:
: Provides medical input to all areas of clinical development projects
: related to CNS in AP including the Product Development Plan (PDP), Study
: Protocols, case report forms (CRF), data evaluation, clinical study report,
: publications, NDA submission and response to regulatory enquiries. Ensures
: that all documents are developed with sound, valid clinical judgment in a
: timely manner Represents PDCC-M in the Local or International Project Team (
: IPT) as core member
: Primary Responsibilities include:
| s*******r
发帖数: 3429 | 4 挺多的。
【在 t**n 的大作中提到】
: MD做clinical development的愿意回国的多吗？
:
: ,
: (
| b**u
发帖数: 2761 | 5 估计要看哪里拿的MD了，如果是在美国有执照的话，多半不会回去做这个吧。
【在 t**n 的大作中提到】
: MD做clinical development的愿意回国的多吗？
:
: ,
: (
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