от компании (организации): Pfizer в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Лекарственные препараты"
с заработной платой: по договоренности
Вакансия № 13840366 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 29 июля 2024 года.
Дата обновления вакансии № 13840366 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 22 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 13840366 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
1–3 года
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Hub Labeling Manager
Position Purpose
The Hub Labeling Manager (HLM) is responsible for preparing Local Product labeling documents and their associated Local Language labeling documents for their assigned markets, and for updating the labeling documents on a timely basis according to internal SOPs and external regulatory requirements.
This role will also act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labelling requirements and participate in the sharing of intelligence. Additionally, this role will support the use and development of current and new tools, technologies and processes to support global label development, submission and approval in respective countries.
Primary Responsibilities
The Hub Labeling Manager (HLM) is responsible for the delivery and management of labeling text through the appropriate processes and systems, and through interaction with colleagues in other roles.
Key activities include:
- Using regulatory expertise and analytical skills to review and develop appropriate content for local labeling documents based on existing approved content, seeking strategic and medical input from others as required, and recording any decisions made.
- Communicating, planning, prioritising and delivering labeling documents according to company targets and submission requirements.
- Liaising with stakeholders using the most effective means of communication; presenting information in an optimal format and level of information for that audience.
- Developing subject matter expertise for assigned markets or products, and ongoing development of labeling expertise.
- Working within a framework of internal SOPs and working practices, and external regulatory requirements, so that the high-quality delivery of outputs and compliance is maintained.
- Appropriately tracking labelling projects via defined procedures and systems.
- Supporting the use of relevant tools and technologies within the course of the label development and translation process.
Technical Skill Requirements
- Knowledge of global/regional regulations and guidelines pertaining to the pharmaceutical industry is essential
- Experience of working within a pharmaceutical regulatory role is preferred
- Ability to understand, analyze and propose information to be included in local labeling documents and the ability to logically review whether the changes have an impact on other sections of the same document is essential
- Ability to delegate work to others, including working with internal and external vendors is essential
- Proficiency in the use of document management systems, repositories and reporting tools is preferred
Qualifications
- At least 2 years of experience working within the pharmaceutical industry is essential, preferably in a regulatory role
- Degree or equivalent qualification in pharmaceutical or other scientific subject
- Experience of delegating work to others or working with vendors is preferred
- Written and verbal communications should be clear and effective; fluency in English and Russian is essential
- Excellent project management skills, and ability to plan, prioritize and deliver within specific deadlines are preferred
Откликнуться на эту вакансию: Hub Labeling Manager
Предыдущая вакансия:
Вакансия № 13840358 на должность Ведущий юрисконсульт от компании ООО ЗВК БЕРВЕЛ в городе (населенном пункте) Рыбное