Regulatory Operations Analyst

Red Nucleus
10dRemote

About The Position

Red Nucleus is expanding the R&D team and is hiring a Regulatory Operations Analyst This role can be remote based in the US. COMPANY DESCRIPTION: Red Nucleus is a premier provider of global solutions for R&D, Medical Affairs, Value & Evidence, and Commercial teams within biopharmaceutical, medical device, and diagnostics industries. Squarely focused on the life sciences industry for more than 30 years, Red Nucleus takes pride in our long-term relationships with industry leaders, as well as our strategic partnerships with innovative startups. We are focused on developing thoughtful, high-quality solutions that are in accordance with each client’s unique culture and needs. Our clients trust us to build impactful, award-winning programs that deliver actionable insights and measurable results. Job Overview: Analyst / Sr. Analyst is responsible for supporting and providing hands-on operational support in the RegOps division including managing document review, communication and coordination. This role will collaborate with the RegOps leadership team, submission leads and associates for general support.

Requirements

  • Bachelor’s degree required.
  • 0-2 years of experience in consulting or a relevant field.
  • Rigorous attention to detail and accuracy
  • Self-starter and driven
  • Ability to multi-task with superior organization skills
  • Strong ability to work independently as well as be an integral part of a team
  • Dependable and flexible
  • Excellent written, verbal communication, and time management skills
  • Proficient in Microsoft Suite software including Project, Excel, Word, PowerPoint, Visio
  • Working in a global environment with an understanding of cultural differences and work practices

Responsibilities

  • Provide legal document review support including non-disclosure agreements, statement of work and other legal documents and ensuring documents are fully executed and archived.
  • Managing and updating various planning and sales systems including contributing to invoices, timecards and various financial updates.
  • Assist with division communication and team calendar management including group meetings, trainings and conference coordination.
  • Collaborate with Marketing to develop and maintain RegOps marketing material, including outward facing social media engagements (i.e. LinkedIn) and proactively respond to prospective and potential future clients.
  • Contribute to formatting and quality checking of regulatory submission documents and reports as requested.
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