Medical Lead

Found in: Talent CN S2 - 2 weeks ago


Beijing, China Astellas Pharma Inc. Full time

开发创新疗法是科学领域中最具挑战性、最重要和最有个人价值的领域之一。在我们追求将创新科学转化为患者价值的过程中,成为安斯泰来的一员是一个令人兴奋的时刻!我们是一家拥有独特的合作和以患者为中心的文化的公司。现对以下职位进行公开招聘,欢迎符合条件的候选人投递简历。

LocationBeijing

Responsibilities:

1、People management

•Working as TA lead by medical, recruit medical manager, coach and supervise them, support Department head to build up good team culture.

2、Be expert on the related therapeutic areas of the new pipeline for ACN and headquarter

•Acknowledging the guideline, academic progress and trends of the related therapeutic area, reading related reference/documents, attending academic conference

•Reading internal data, grasp the pipeline information

•Effective communication with KOL, understanding Chinese clinical practice and clinical requirements 

•Discussing and drafting CDP of new pipeline

3、Reviewing/Composing clinical study protocol based on development strategy of headquarter and requirements of Chinese registration and clinical practice

•Closely consulting with headquarter, acknowledging the development strategy of headquarter

•Understanding the details of the protocol, confirming reasonable protocol design after communicating with development department (Development Regulatory Affairs, Development Clinical Department, Data Management and Statistician, Development Strategy & Management Manager), PV & QA Department, RA & Supply & Sales management Department, external experts (Clinical Experts, Statisticians, Pharmaceutical Experts) and CDE reviewers

•Working closely with project team members, draft review process and timeline of the protocol

•Reviewing/Composing clinical study protocol

4、Medical monitoring and giving scientific medical support for ongoing clinical studies

•Composing and executing medical monitor plan with discussing among project members based on project requirement

•Familiar with clinical study process, conducting regular medical review on clinical data cooperating with project members

•Solving medical questions of the protocol (e.g. medicine background, inclusion/exclusion criteria, combination medication,dosage adjustment of the study drug and discontinuation criteria et al.)

•Working closely with project team members, discussing and reviewing clinical study related documents and timeline

5、Reviewing and composing CSR and giving medical support for disclosure and publication of the clinical study results

•Familiar with the requirement of the clinical CSR, Scientific analyzing and discussing for the clinical data, reviewing/composing clinical CSR

•Working closely with project team members, discussing and drafting review process and timeline of the clinical CSR

•Giving medical support and comments to the disclosure and publication of the clinical study data

6、Supportive for IND and NDA

•Drafting CDP and giving medical support with discussing among project members for the submitting and approval of the IND and NDA

•Working closely with Development Regulatory Affairs, answering medical questions from CDE reviewers, and preparing medical documents and solving medical issues for the CDE consult meeting

7、Others

•Based on the work arrangement

Qualifications:

1、Education & knowledge

•Master’s degree in Medicine or higher.

•ICH/Chinese GCP

•Compliance and Pharmacovigilance 

•Pharmaceutical industry environment

•Clinical development process

2、Skills

•Fluency in English

•Excellent in oral presentation both in English and Chinese

•Be good at communication and coaching

•Excellent negotiation skill

3、Experience

•Training/experience of Medical Monitor or Project Physician in clinical development in the pharmaceutical industry or CRO, people management experience.


  • Medical Marketing Manager

    Found in: Talent CN S2 - 2 weeks ago


    Beijing, China Coloplast Full time

    主要职责/责任Essential Duties / Responsibilities Annual medical marketing and medical education plan development which is aligned with medical marketing and hospital marketing strategies and plan Provide medical and scientific input to promote a higher standard of ostomy care, thereby strengthening our position today and in the future Develop...

  • Medical Science Liasion

    Found in: Talent CN S2 - 2 weeks ago


    Beijing, China Boehringer Ingelheim Full time

    About Human Pharmaceutical BusinessWith global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest:...

  • Medical Marketing Manager

    Found in: beBee jobs CN - 2 weeks ago


    Beijing, Beijing, China Coloplast AS Full time

    主要职责/责任Essential Duties / ResponsibilitiesAnnual medical marketing and medical education plan development which is aligned with medical marketing and hospital marketing strategies and planProvide medical and scientific input to promote a higher standard of ostomy care, thereby strengthening our position today and in the futureDevelop strong...

  • Marketing Team Lead

    Found in: Talent CN S2 - 2 weeks ago


    Beijing, China Pfizer Full time

    POSITION SUMMARY Own portfolio strategy to maximize the franchises business to achieve earnings and revenues objectives and lifecycle management; Assist the Marketing Director to build marketing capabilities of the product management team to achieve effectiveness and efficiency of the business. Define and Drive Country Specific TA and Brand Strategy....

  • RA Manager, Medical Device

    Found in: Talent CN S2 - 3 weeks ago


    Beijing, China Bayer Full time

    At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Clinical Medical Manager-Beijing

    Found in: Talent CN S2 - 2 weeks ago


    Beijing, China Novo Nordisk AS Full time

    Job description : 1: Identify KOLs, investigators and research centres Identify and map KOLs, investigators and research centres within the relevant therapy areas Collaborate closely with clinical operations teams in CDC, region, IO-SO and HQ during feasibility and allocation process Identify and engage with relevant patient advocacy groups...

  • Clinical Medical Manager-Beijing

    Found in: Talent CN S2 - 2 weeks ago


    Beijing, China Novo Nordisk Full time

       Job description:1: Identify KOLs, investigators and research centresIdentify and map KOLs, investigators and research centres within the relevant therapy areas Collaborate closely with clinical operations teams in CDC, region, IO-SO and HQ during feasibility and allocation processIdentify and engage with relevant patient advocacy groups and...

  • Director, CMM lead

    Found in: Talent CN S2 - 2 weeks ago


    Beijing, China Novo Nordisk AS Full time

    Purpose of the job Through team of direct reports facilitate execution of clinical trials related to New Therapy Areas with focus in CVD area by providing medical/scientific expertise and advice based on interactions with investigators, site staff, KOLs, independent professional associations and patient advocacy associations as well as perform early...

  • Director, CMM lead

    Found in: Talent CN S2 - 2 weeks ago


    Beijing, China Novo Nordisk Full time

       Purpose of the jobThrough team of direct reports facilitate execution of clinical trials related to New Therapy Areas with focus in CVD area by providing medical/scientific expertise and advice based on interactions with investigators, site staff, KOLs, independent professional associations and patient advocacy associations as well as perform early...

  • English into Traditional Chinese Medical Translators

    Found in: Talent CN S2 - 2 weeks ago


    Beijing, China Welocalize Full time

    As a trusted global transformation partner, Welocalize accelerates the global business journey by enabling brands and companies to reach, engage, and grow international audiences. Welocalize delivers multilingual content transformation services in translation, localization, and adaptation for over 250 languages with a growing network of over 400,000...

  • Lead Application Engineer

    Found in: Talent CN S2 - 2 weeks ago


    Beijing, China Baker Hughes Full time

    Are you a Tender/Proposals Specialist looking for a new challenges? Are you passionate about providing complex technical and commercial solutions? Join our Application Engineering team Panametrics designs and manufactures a range of sensing instrumentation that are utilized in a vast array of market segments. Our products help customers...

  • Access Policy Advocacy Lead

    Found in: Talent CN S2 - 2 weeks ago


    Beijing, China Roche Full time

    The Position Primary Purpose of Job (Job Summary) This full-time position is responsible for developing China access policy framework in fitting with the access policy dynamics and prospectively developing opportunities through the collaboration with international and national access policy stakeholders, and advocate and shape positive access...

  • 辉瑞制药-医学事务经理-北京/上海

    Found in: Talent CN S2 - 2 weeks ago


    Beijing, China Pfizer Full time

    Evaluate new products, new indications, new research programs, new business potentials of defined therapeutic areas from medical perspective to support new product introduction and line extension Align with cross function team including marketing, CCO team, global team etc, develop post marketing research strategy based on Registration/Market needs ...


  • Beijing, China Takeda Full time

    Description Regulatory Affairs Lead, China PDT is responsible for supporting the PDT BU’s global plasma sourcing strategy for China. S/he also leads local regulatory policy initiatives related to plasma and plasma sourcing to help ensure network flexibility and continuous supply of PDTs to patients in need in China. The Regulatory Affairs Lead,...

  • Senior Engineer, Mechanical

    Found in: beBee S CN - 4 weeks ago


    Beijing, China GE Healthcare Full time

    Job Description Summary In this role ,you need to develop innovative designs to meet all requirements for performance, reliability, cost and manufacturability. GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into...

  • Distribution Planning Supervisor

    Found in: Talent CN S2 - 2 weeks ago


    Beijing, China CN20 Alcon (China) Ophthalmic Product Co. Ltd Company Full time

    At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...

  • 辉瑞制药-Marketing Manager-偏头痛-北京

    Found in: Talent CN S2 - 2 weeks ago


    Beijing, China Pfizer Full time

    POSITION SUMMARY Contribute to portfolio management or big strategic brand strategy to maximize the franchises business to achieve earnings and revenues objectives; Define and Drive the portfolio or big strategic Brand Strategy, drive the growth and lifecycle management; Interface with WWT and global/local functional team as TA platform lead. Assist the...

  • CTMo Line Manager

    Found in: beBee S CN - 4 weeks ago


    Beijing, China Bristol Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Key Account Manager

    Found in: Talent CN S2 - 2 weeks ago


    Beijing, China Covestro Full time

    Major Tasks:Leads and coordinates the business activities for EP HC at key accounts; takes full responsibility for the existing running business, developing new projects/applications, managing the customers’ project pipeline and the process of material specificationDevelop and implement account strategy (non-transactional) as well as value proposition...

  • Commercial Operation Manager

    Found in: Talent CN S2 - 2 weeks ago


    Beijing, China CN20 Alcon (China) Ophthalmic Product Co. Ltd Company Full time

    At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...