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Program Manager - Scientific - Senior

Lexington, MARandstad LifeSciences


Chat with me now! - https://flashrecruit.com/jobs/300221
 

Program Manager - Scientific - Senior

 

Job Summary

  • For assigned projects, is responsible for working collaboratively with the Global Regulatory Lead (GRL) and cross functional project teams to provide project management support to ensure global regulatory strategies are developed and seamlessly executed upon, enabling successful filings with Health Authorities. 
  • Manages and provides supports with the planning and execution of  high quality regulatory submissions for assigned products, including both pre-approval and postmarketing submissions. This includes major global regulatory submissions (NDAs, BLAs, MAAs, INDs, and supplementals) and other US submissions including  amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, label updates etc.,consistent with US regulatory requirements. Responsible for drafting and preparation of forms and cover letters required for US Submissions.
     

Job Responsibilities

40% of the time

  • Provide project management support for product-specific global regulatory team meetings (GRTs) and cross-functional major submission team meetings to oversee, plan and deliver GRT goals and regulatory submissions. 
  • For assigned programs, prepare meeting agendas, meeting minutes,and together with the team prepare effective issue and risk management plans.Develop and actively manage project timelines and integrated submission project plans. Prepare and distribute reports and trackers to communicate updates and project status.
  • For speficied programs, proactively drive project teams, establishing an appropriate level of urgency and keen focus on deliverables.Track Project variances and assist in the identification of root causes. Conduct lessons learned sessions to identify areas for improvement. 

50% of the time

  • Plan and coordinate the delivery of  US submissions, including authoring of certain M1 components (e.g. drafting of forms and cover letters).
  • Coordinate and consult with GRL and other departments on the content, preparation and assembly of regulatory documentation in support of US filings. Perform final editorial checks of regulatory content prior to hand off to submission management.
  • Coordinate and provide operational support for FDA meeting requests, meeting rehearsals, briefing book preparations and assist in the preparation of  meeting minutes of FDA meetings.
  • For specified programs, support the GRPMUS Leads with project management and tactical exection of regulatory strategy deliverables for complex programs/projects.

10% of the time

  • Responsible for ensuring regulatory compliance for all assigned responsibilites. 
  • Act as a conduit of information between assigned cross-functional submission teams and the GRT.
  • Work with submission management on the development of regulatory submissions.

Education & Qualifications 

  • BA/B.S in a scientific, healthcare or related field or equivalent experience
  • 4+ years project management experience in RA or Drug Development required.  2+ years experience in Regulatory Affairs required.
  • Knowledge of FDA regulations and guidelines on drug development and the approval process  for NDA/BLA and postmarketing supplements
  • Excellent communication skills both written and verbal
  • Excellent interpersonal and negotiation skills
  • Demonstrates strong ability to collaborate, interact and work effectively with other departments as well as external organizations
  • Excellent organizational skills, ability to multitask and with attention to detail; capable of managing multiple projects within assigned timelines
  • Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

 


Chat with me now! - https://flashrecruit.com/jobs/300221