Site Activation & Regulatory Assistant (Ukraine)

Location: Kyiv, Kyiv City, Ukraine

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Requisition Number: 1269

Position Title: Site Activation & Regulatory Assistant

External Description:

SUMMARY: The Site Activation and Regulatory Operations Assistant provides general and project specific administrative support to Regulatory Affairs, Site Contracts and Site Activation groups.
 
RESPONSIBILITIES:
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.
 
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

 
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

 #LI-MK1

City:

State: Kyiv

Employment Type: Regular

Community / Marketing Title: Site Activation & Regulatory Assistant (Ukraine)

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Kyiv, UA

CountryEEOText_Description:

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