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We are seeking a Senior Medical Writer (Early Development) - EMEA.
As a Senior Medical Writer within the Early Development team, you will provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.
Essential Functions:
Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies (Phase 1, 1b and 2a)
May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client specific processes.
May assist in program management activities. Identifies and resolves out-of scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
Represents the department at project launch meetings, review meetings, and project team meetings.

We are seeking an Experienced Clinical Research Associate (CRA).
Position Overview:
Performs and coordinates different aspects of the clinical monitoring and site management process.
Conducts remote or on-site visits to assess protocol and regulatory compliance and handles required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.).
Acts as a site processes specialist, ensuring that the trial is conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness.
Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

We are seeking a Country Approval Specialist
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.
Responsibilities:
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.