Medical Advisor ONC_Head & Neck-Beijing

Posted 11 Sep 2019

Beijing - all, Beijing - China

Req Id 195905

Details

A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role:

  • Related to marketing or other business activities

1.    Collaborate with marketing for the organization of KOL meetings and advisory boards meetings

2.    Initiate, conduct IST and PMS of marketed products to come out medical opinion in order to support marketing needs

3.    Responsible for publication:

n.    Develop the domestic and global (when requested) publication strategy

o.    Authors/reviews abstracts and publications of domestic IST or PMS, and global (when requested) studies

4.    Represents Medical to KOL and medical organizations

5.    Provide medical training for sales and marketing, review and update the relative training materials yearly based on needs

6.    Evaluation scientific aspects of in- and out-licensing products

7.    Provides medical support for Internal Marketing Teams in the relevant therapeutic area (like: promotion material development and check etc.)

  • Related to Clinical Development

1.    Primary contact person for all medical/safety aspects within a given study

2.    Any medical aspects having global implications (e.g. safety updates, important medical decisions regarding the study indication) will be discussed between MA and Global Project Leader

3.    Protocol/amendment (related to medical sciences) development and finalization

4.    Medical check for site selection

5.    Medical discussions with investigators

6.    Medical training for entire study team, investigators and CRO staff (if applicable)

7.    Answer all medical related questions during the study, e.g. questions from EC-committees, investigators, etc.

8.    Ongoing data review in clinical trials for patients’ safety, efficacy, validity

9.    Gives safety updates to Global Project Leader

10.   Reviews or writes medical narratives and ensures that the narratives meet an acceptable medical standard in the Medical Research Report

11.   Supports the coding team for medical history, concomitant medications and adverse event coding

12.   Reviews the statistical tables and interprets clinical data for the Medical Research Report

13.   Develop, reviews and approve the final study Medical Research Report both in English and Chinese

  • Related to Regulatory Affairs

1.    Involved in the preparation for the medical sections of regulatory submissions (IND and NDA)

2.    Prepares the medical section of briefing documents for CDE evaluation meeting, pre-meeting with regulatory authorities

3.    Develops scientific reports or responses to study-specific medical issues that may be raised by regulatory agencies

 

4.    Related to the project management

Responsible to track the project the status and complete the monthly report

 

Who you are:

•      Master or advanced degree in clinical medicine, Doctors degree is preferred

•      At least 3 years experiences as doctor in responsible therapeutic area

•      2-4 years multi-national pharmaceutical companies experiences is preferred

•      Good English at listening, speaking, writing and reading

•      Strong medical knowledge in the therapeutic area

•      Professional knowledge on clinical medicine and pharmaceutical

•      Knowledge of policies and procedures in Clinical Trials and drug Registration

•      Ability to face challenges

•      Self-learning ability

•      Completion of GCP training is required

 

HR 95601

Functional area: Regulatory & Medical Affairs


What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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