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Regulatory Project Manager – REMOTE

ClinChoice

This is a Full-time position in las vegas, nv posted July 31, 2022.

Job Title: Regulatory Project Manager (Senior Manager or Associate Director Level)

Employment Type: Full-Time

Location: Remote-US East Coast Time Zone (~10% travel)

About ClinChoice

ClinChoice is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our Customers. ClinChoice was established in the US in 1995, and has grown to more than 3,000 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region.

DUTIES & RESPONSIBILITIES:

Job Summary

ClinChoice is seeking a Sr Manager/ Associate Director to lead our Regulatory Project Management team. This is a client facing role with a focus on developing and growing client trust while driving team timeline and performance. The role will include a variety of activities to support the activities of a rapidly growing company including driving timelines for project completion, developing metrics and managing changes for long term support, conducting budget analysis, and review contract scopes of work. A strong working knowledge of pharmaceutical market access is required to provide the needed guidance to both clients and internal teams. This role will involve both people and project management as ClinChoice looks to develop Project Managers who are able to directly support client project. Senior Manager or Associate Director will be considered based on skillset and experience.

Job Duties

  • Grow and lead the Regulatory Affairs Project Management Team
  • Work with Regulatory Subject Matter Experts (SMEs) to develop timelines for short- and long-term projects focused on gaining market access. This includes preparing submission for clinical trials and market approval of both pharmaceutical and medical device products (i.e., INDs, IDEs, CTAs, Technical Dossiers, 510(k)s, PMA, NDAs, and CTDs)
  • Develop and/or manage metrics and KPIs for long term outsourcing projects supported by ClinChoice
  • Drive timelines to ensure on-time delivery
  • Build trusting relationships with clients to understand their ongoing and future project needs such that, in coordination with SMEs, you are able to present solutions
  • Be forward facing to clients providing project updates and translating project deliverables to teams across multiple cultures and experience levels.
  • Work with cross cultural teams and clients
  • Support and train entry level Project Coordinators
  • Provide a voice of motivation and support to teams. Provide creative solutions to regulatory or project hurdles.

· Grow client relationships through skilled and open conversations.

  • Collaborate and support the regulatory team and cross functional partners through the various processes
  • Participate in group meetings and provide tactical approaches to addressing issues of moderate to high complexity.
  • Contribute to routine local process improvements, which have an impact on the Regulatory Affairs function.
  • Perform document filing and retrieval functions as directed, or in conjunction with departmental SOPs.
  • Ability to travel up to 10%.

Skills / Experience

  • Bachelor or master’s degree in science or related discipline (or equivalent experience)
  • 5+ years relevant experience
  • Regulatory experience within the pharmaceutical industry or other relevant experience
  • Strong working knowledge of drug development and market access
  • Experience managing costs and/or invoices related to projects
  • Strong Project Management skills required, including experience in leading a team
  • Experience managing multiple projects and diverse teams
  • Self-starter with an ability to work in team environment with minimal supervision
  • Strong communication skills, as well as strong meeting presence
  • Use diverse experience to meet deadlines and be detail orientated
  • Strong critical thinking and analytical skills required

ClinChoiceis an Equal Opportunity Employer / Committed to Diversity