Global Clinical Publishing Associate

Ensure compliance with internal and external guidelines, to compile and add electronic navigation to clinical and regulatory documents. Support the timely submission of documents to the Health Authorities (HAs) and provide publishing consultancy to the clinical teams and other line functions.

Job Description

Major accountabilities:

Key performance indicators:

Minimum Requirements:

Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria.
Effective interpersonal skills, strong written and oral communication and presentation skills.
Project management and time management skills to manage multiple ongoing projects simultaneously.
Familiar with regulatory requirements and HA guidance, including FDA regulations, ICH and EMA guidelines/directives.
Working knowledge of regulatory affairs.
Works independently and with minimal supervision.
Proficiency with computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly.
Analytical skills and problem solving skills.
Ability to coordinate and work effectively with cross-functional teams.
Work Experience:

Skills:

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Skills Desired