Assistant, Regulatory Affairs

at  Worldwide Clinical Trials

OTHER SKILLS AND ABILITIES:

• Clearly, proven organizational and time management skills are essential attributes
• Excellent written and verbal communication skills to clearly and concisely present information
• Good interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Excellent ability to handle multiple tasks
• Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval
• Excellent self-motivation skills
• Willingness to adapt to new procedural requirements
  Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

REQUIREMENTS:

• 2 years office/business experience in a supporting role
• Preferable CRO/pharmaceutical industry experience.
• Bachelor’s degree or equivalent preferred

Tasks may include but are not limited to:

• If applicable, under the direction of a senior member of the department, coordinate & manage compilation of regulatory & ethics committee submissions throughout EU, CIS, Asia Pacific and Latin America regions
• Assist with the coordination of translation of regulatory correspondence and submission documents such as protocols, synopsis, ICF and labels
• Pack and dispatch regulatory submissions, site contracts, and site documents, follow up for delivery confirmation, obtain and file acknowledgement receipts and update relevant tracking tools
• Perform administrative QC of regulatory submissions, site documents and site contracts to ensure correct completeness and formatting
• Liaise with Finance requesting fee payment to Regulatory Authorities
• Closely monitor the assigned Therapeutic mailbox and triage requests to the correct team members for prompt action
• If applicable, contribute as owner of Country Intelligence Pages
• Coordinate Contracts signatures by Worldwide authorized personnel, where applicable
• Ensure department specific study files are submitted to Central Records and are consistently audit ready
• Manage tracking of original site contracts delivery to Worldwide Central Archive and/or Sponsor
• Prepare and submits hardcopies or electronic copies of site essential documents for storage at Central Records
• Support Business Development activities by archiving emails and assisting with generation of slides
• Provide relevant administrative training and support to junior staff
• Provide admin support to Country Intelligence pages and database, Feasibility activities
• Manage third party vendors such as printing, courier and translation service providers
• Provide general administrative assistance for the smooth running of the department – organize meetings and record minutes, manage diaries, assist with process improvement initiatives
• May administratively support therapeutic area specific training activities in coordination with SAR department Training Lead if needed or for professional self-development if desired.

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.