לוח משרות דרושים רישום / רגולציה רפואית לדוברי אנגלית, לחיפוש זה נמצאו 2 משרות !

we are looking for a Country Approval Specialist.
As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals. This opportunity is an exciting prospect for a big pharma company and for a new division focused on Oncology/Cell therapy
What Youll Do:
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 PPDs 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.
Entes 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 provided.

we are looking for a Principal Medical Writer (Publications).
The Publications and Scientific Communications team, a part of Medical Writing and Healthcare Communications, prepares medical publications, abstracts, posters, presentations, and other scientific communications. Our dynamic, highly collaborative team focuses on providing quality writing to internal collaborators and external pharmaceutical and biotech clients.
A day in the life:
Write, edit, and handle publications and other scientific communications (manuscripts, posters, abstracts, oral presentation slide decks, and review articles), on time, within budget, and with little instruction. Provides senior review of documents.
Appropriately resolve or raise project management issues, such as out-of-scope activities
Ensure compliance with quality processes and requirements
Represent the team as a prime contact on projects, establishes clients relationships.
Assist in business development initiatives
Lead or provide input on initiatives for process improvement, provides training and mentorship of other writers.