Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

The following skills are required to be successful in this position:

preparation and assembly of global regulatory submissionsinteracting with sponsors,review and assess clinical trial regulatory documents,review and assess scientific literature. manages project teams and preparationparticipate in launch meetings, review meetings and project team meetings.

Optional skills:

Experience with bid defense meetings

Qualifications - External

What the role requires you to have:

Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the jobKnowledge of the global clinical trials landscape

Knowledge, Skills and Abilities:

Excellent command of the English language (written and oral) as well as local language where applicableExcellent attention to detail and quality as well as excellent editorial/proofreading skillsExceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departmentsAdvanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologiesStrong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projectsCapable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverablesExcellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelinesExcllent analytical, investigative and problem-solving skills