от компании (организации): Worldwide Clinical Trials в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Клинические исследования"
с заработной платой: по договоренности
Вакансия № 22144892 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Суббота, 10 августа 2024 года.
Дата обновления вакансии № 22144892 на сайте Работа в Москве и Московской области (МО, Подмосковье): Суббота, 21 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 22144892 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
не требуется
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Regulatory Affairs Assistant - Moscow
Regulatory Assistant provides general and project specific administrative support to Regulatory Affairs group.
RESPONSIBILITIES:
Tasks may include but are not limited to:
- If applicable, under the direction of a senior member of the department, coordinate & manage compilation of regulatory & ethics committee submissions throughout EU, CIS, Asia Pacific and Latin America regions
- Assist with the coordination of translation of regulatory correspondence and submission documents such as protocols, synopsis, ICF and labels
- Pack and dispatch regulatory submissions, site contracts, and site documents, follow up for delivery confirmation, obtain and file acknowledgement receipts and update relevant tracking tools
- Perform administrative QC of regulatory submissions, site documents and site contracts to ensure correct completeness and formatting
- Liaise with Finance requesting fee payment to Regulatory Authorities
- Closely monitor the assigned Therapeutic mailbox and triage requests to the correct team members for prompt action
- If applicable, contribute as owner of Country Intelligence Pages
- Coordinate Contracts signatures by Worldwide authorized personnel, where applicable
- Ensure department specific study files are submitted to Central Records and are consistently audit ready
- Manage tracking of original site contracts delivery to Worldwide Central Archive and/or Sponsor
- Prepare and submits hardcopies or electronic copies of site essential documents for storage at Central Records
- Support Business Development activities by archiving emails and assisting with generation of slides
- Provide relevant administrative training and support to junior staff
- Provide admin support to Country Intelligence pages and database, Feasibility activities
- Manage third party vendors such as printing, courier and translation service providers
- Provide general administrative assistance for the smooth running of the department – organize meetings and record minutes, manage diaries, assist with process improvement initiatives
- May administratively support therapeutic area specific training activities in coordination with SAR department Training Lead if needed or for professional self-development if desired.
OTHER SKILLS AND ABILITIES:
- Clearly, proven organizational and time management skills are essential attributes
- Excellent written and verbal communication skills to clearly and concisely present information
- Good interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Excellent ability to handle multiple tasks
- Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval
- Excellent self-motivation skills
- Willingness to adapt to new procedural requirements
- Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint.
REQUIREMENTS:
- 2 years office/business experience in a supporting role
- Preferable CRO/pharmaceutical industry experience.
- Bachelor’s degree or equivalent preferred
- English Upper-intermediate.
WHAT WE OFFER:
- International environment – more than 60 countries
- Extensive portfolio of clinical trial technology
- Official employment
- Medical insurance with stomatology for associate and one of close relatives
- Sick leave benefit with paid 10 days every year
- Life insurance package
- EPS program (eligible after 3 months of work, to help deflect financial loss value of our local currency against the US Dollar)
- Supplemental social compensations
- A-class comfortable office
- Training & Development, including free online English lessons.
Откликнуться на эту вакансию: Regulatory Affairs Assistant - Moscow
Предыдущая вакансия:
Вакансия № 22144873 на должность Аналитик (развитие финансовой системы) от компании Росгосстрах в городе (населенном пункте) Москва