SR Coordinator Regulatory Submissions Operations

About the role

Regulatory Submissions Operations uses specialized technology and knowledge to format, edit and compile paper and electronic documents related to the pharmaceutical industry regulatory submissions throughout each phase of drug development and through the drug product life cycle. This position provides application submission, prepares specialized electronic files for drug registrations, and oversees and maintains document management databases for version and revision control.

Responsibilities

• Assess and negotiate timelines
• Manage client documents used in submissions
• Process client documents within publishing software
• Identify concerns and communicate with upstream and downstream partners

Qualifications

• Experience in advanced formatting of Microsoft Word documents is required
• Experience in formatting and editing Adobe documents required
• Familiarity with Excel required
• Publishing experience in eCTD preferred
• Project management experience is a plus
• Attention to detail
• Strong written and oral communication skills

What is expected of you and others at this level

• Effectively applies knowledge of job and company policies and procedures to complete a variety of assignments
• Applies advanced skills to resolve complex problems independently
• May modify process to resolve situations
• Works independently within established procedures; may receive general guidance on new assignments
• May provide general guidance or technical assistance to less experienced team members

Pay

Anticipated Pay Range: $26.30 – $33.75 per hour USD

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs