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Associate LTM - Regulatory Specialist

Johnson & Johnson
Posted May 25
Full Time
Will County, Illinois

Maintains up to date knowledge, ensures adherence and compliance with local regulatory requirements and associated documents

  • Ensures all submissions information & requirements are kept up to date in a central repository for project teams
  • May register Company's studies, conducted in Israel, in the Israeli Ministry of health (MoH) 'my trial' website
  • Works in close collaboration with the Clinical Research Manager (CRM), the assigned Local Trial Manager and the CTA (and the Site Manager, if applicable), provides status updates on an ongoing basis, escalates when required .
  • May assist with the translation and co-ordination of translations for documents required for submission
  • Contributes to the submission activities including local adaptation of study ICF(s)
  • May be delegated to act as the primary contact with investigative sites during submission activities
  • May support in the collection and distribution of documents from / to sites
  • Ensures all essential documents are reviewed in accordance to local regulations and global and local SOPs and other procedural documents.
  • Responsible to prepare and submit EC and MoH (if applicable) application(s), determining appropriate follow up until receipt of final approval
  • Tracks metrics and study submission timelines to identify trends and opportunities for improvement
  • Interacts with multiple cross-functional teams to facilitate and assist in obtaining and compiling response letters to the ECs or MoH
  • Tracks and prepares for submission, throughout study duration, on an ongoing basis per local regulatory requirements
  • May assist in ensuring that the TMF for the study is up to date
  • A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
  • Minimum two to four years of pharmaceutical and/or clinical trial experience is preferred, however other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.
  • Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including GCP and local regulatory requirements.
  • Pharmaceutical industry experience directly involved with study start up processes and/or submission to IECs / HA is preferred.
  • Requires strong attention to details in composing and proofing materials
  • Able to establish priorities and meeting tight deadlines.
  • Pro-active and problem-solving attitude.
  • Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands with flexibility.
  • Self-motivation, able to take initiative and work independently with minimal supervision.
  • Able to proactively seek guidance when necessary.
  • Team player, collaborative attitude, able to work with cross-functional teams.
  • Superior interpersonal communication, excellent teamwork ability and excellent human relationships are required.
  • Excellent planning and organizational skills.

Personal resilience, perseverance, energy and drive.

  • Proficient in speaking and writing the country language and English language.
  • Excellent written and oral communication skills.
  • Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred.
  • Flexible mindset and ability to work in a fast-changing environment. Ability to work on multiple trials in parallel.
  • Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.