от компании (организации): PPD в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Фармацевт"
с заработной платой: по договоренности
Вакансия № 15817761 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 11 августа 2024 года.
Дата обновления вакансии № 15817761 на сайте Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 7 октября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 15817761 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: Country Approval Specialist
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to?improve health.?You will be joining a truly?collaborative and winning culture?as we strive to bend the time and cost curve of delivering life-saving therapies to patients.?
Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.?
As a Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.
Essential Functions of the role also include:
- Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy
- Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients
- Provides project specific local SIA services and coordination of these projects
- May have contact with investigators for submission related activities
- Key-contact at country level for either Ethical or Regulatory submission-related activities
- Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
- Achieves PPD’s target cycle times for site
- May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable
- May develop country specific Patient Information Sheet/Informed Consent form documents
- May assist with grant budgets(s) and payment schedules negotiations with sites
- Supports the coordination of feasibility activities, as required, in accordance with agreed timelines
- Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner
- Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs
- Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provide.
Our team is expanding, so if this role seems interesting for you, here are the requirements:
Education and Experience:
- Life-science degree
- 1+ year experience with submissions is mandatory.
Knowledge, Skills, and Abilities:
- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Good negotiation skills
- Good computer skills and the ability to learn appropriate software?
- Good English language and grammar skills
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, under direction, as required?
- Basic organizational and planning skills
- Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations.
At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
PPD Defining Principles:??
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -??
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.?
Diversity Statement
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
Откликнуться на эту вакансию: Country Approval Specialist
Предыдущая вакансия:
Вакансия № 15817758 на должность Фармацевт-провизор (м.Новокузнецкая, м. Маяковская, м.Театральная) от компании Планета здоровья в городе (населенном пункте) Москва