Country Approval Specialist Germany job in Munich, Germany

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Clinical Scientist

Location: Germany

This vacancy has now expired. Please see similar roles below...

An opportunity has arisen for a Country Approval Specialist, in Germany. This is an exciting opportunity to join a startup delivering the set up for Clinical trials, collaborating to improve processes, cycle and flexibility.

Job Responsibilities

Prepare, review and coordinate, under guidance, local regulatory submissions in alignment with global submission strategy
Provide, under guidance local regulatory strategy advice to internal clients
Provide 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
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.
Support the coordination of feasibility activities, as required, in accordance with agreed timelines
Enter and maintain trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner
Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs
Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Skills and Requirements

Bachelor's degree
0 - 2 years related experience or equivalent combination of education, training, & experience
Effective oral and written communication skills
Excellent interpersonal skills
Strong attention to detail and quality of documentation
Excellent English and German language and grammar skills at least to C1 level
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment or independently, under direction, as required
Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulation

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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