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工作職責(zé):
Why Patients Need YouWe're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
What You Will AchieveYou will help us in preparation, publication, tracking and quality control of our submissions to the regulators in compliance with document management standards. You will be responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical submissions on time. Your innovative use of communication tools and techniques will facilitate in addressing difficult issues and establishing consensus between teams.
It is your focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve ItContribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
Execute, through use of standards and tools, designated operational tasks or through the applicable Pfizer country office, conforming to regulatory submission milestones and applicable regulatory obligations.
Support the interpretation of regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local/regional level.
Work with the team managers to effectively forecast and manage project specific resources utilizing flexible resourcing and global load sharing as normal business practice.
Operate as Subject Matter Expert in dossier types and processes with responsibility for training and mentoring fellow colleagues.
Escalate, inform, and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional partners or Health Authorities.
Lead the implementation and execution of withdrawal strategy in partnership with regulatory strategy.
Responsible for updating the Regulatory parameters for monthly reports to local and global customers.
Supports allocated region/countries, with additional responsibility to support other locations through utilization of global tools.
Able to follow scientific arguments and ensure data is complete and sound.
Ensure maintenance of product and license information in the tracking database.
Responsible for curriculum and training assignments and assist in the collection of training metrics and produces compliance figures for distribution.
任職資格:
Qualifications
Must-Have
Bachelor's Degree
3 years of experience
Relevant experience in electronic submissions build within the Pharmaceutical Industry
Strong knowledge of the drug development process, clinical trial operations, regulatory affairs, and submission management
Understanding of systems and electronic technologies used to support submission and planning activities
Attention to detail and exceptional organizational skills
Presents scientific data effectively, in verbal and written in a logical and persuasive manner
Proven experience managing or delivering through others in a global team environment
Proficient in English, verbal and written
Nice-to-HaveMaster's degree
Relevant pharmaceutical experience of Clinical Trial or regulatory management
Familiarity with pharmaceutical organizational structures, systems, and culture
Experience in project management