出海雷达

高级医学科学家

Sr Medical Scientist

其他限定地区(需当地身份)
公司Syneos Health India Private Limited
薪资$79,800 - $139,600/年
工作地点United States
地域资格限定地区(需当地身份)
时区要求日间重叠约 9 小时,基本正常作息
用工类型Full Time
发布时间13 天前
数据来源Himalayas
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注意地域限制:该职位明确限定在 United States 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。

高级医学科学家
Syneos Health® 是一家领先的全方位整合的生物制药解决方案组织,致力于加速客户成功。我们将独特的临床、医学事务和商业洞察转化为成果,以应对现代市场现实。

我们的临床开发模式将客户和患者置于我们所有工作的核心。我们不断寻找简化和优化工作流程的方法,不仅使 Syneos Health 更易于合作,也使我们更易于加入。

无论您通过功能服务提供商合作方式还是全服务环境加入我们,您都将与充满激情的问题解决者协作,作为团队共同创新,帮助客户实现目标。我们敏捷且富有动力,致力于加快疗法的交付,因为我们热衷于改变生命。

了解我们的 29,000 名员工(分布在 110 个国家)已经知道的事情:
在这里工作,无处不在地重要
为什么选择 Syneos Health

  • 我们致力于发展员工,通过职业发展和晋升;支持性的直线管理;技术和治疗领域培训;同行认可和全面奖励计划。
  • 我们致力于打造 Total Self 文化——在这里你可以真实地做自己。我们的 Total Self 文化是我们全球团结一致的基础,我们致力于照顾好我们的员工。
  • 我们持续打造我们所有人都希望加入的公司,也是客户希望合作的公司。为什么?因为当我们汇聚多样化的思想、背景、文化和视角时,我们能够创造一个让每个人都感到归属感的环境。

职位职责
· 与医学总监合作制定医学计划(医学管理计划、医学数据审查计划和入选审查计划)。与外部专家/顾问/顾问协调获取必要的医学/科学输入,以准备相应的医学计划。
· 执行定期和临时的医学数据清单和数据可视化审查;分析数据以识别风险和数据模式/趋势,并支持医学审查的文档记录。主动识别并解决出现的医学数据审查问题。
· 编写医学数据查询并审查查询回复,与医学总监一起批准查询关闭。
· 可能协助医学总监进行患者档案审查、其他研究层面数据的科学审查、方案偏离审查。

查看英文原文

Sr Medical ScientistSyneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities
· Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan). Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans.
· Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews. Pro-actively identifies and resolves medical data review issues as they arise.
· Authors medical data queries and reviews query responses, approves query closure in association with Medical Director.
· May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed.
· Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed.
· Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met. Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review.
· Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety. Escalates ongoing and newly developed study concerns such as at-risk project deliverables and out of-scope tasks to the project leads in a timely manner.
· Attends and present at Trusted Process meetings and may participate in internal and external audits.
· Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology.
· Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans.
· May manage limited number of direct reports. May participate or conduct interviews.
· Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan). Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans.
· Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews. Pro-actively identifies and resolves medical data review issues as they arise.
· Authors medical data queries and reviews query responses, approves query closure in association with Medical Director.
· May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed.
· Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed.
· Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met. Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review.
· Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety. Escalates ongoing and newly developed study concerns such as at-risk project deliverables and out of-scope tasks to the project leads in a timely manner.
· Attends and present at Trusted Process meetings and may participate in internal and external audits.
· Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology.
· Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans.
· May manage limited number of direct reports. May participate or conduct interviews.
At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
$79,800.00 - $139,600.00The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Originally posted on Himalayas

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