Program Manager

Contract: Roseville, California, US

Salary Range: 60.00 - 70.00 | Per Hour

Job Code: 353606

End Date: 2024-10-09

Job Status: Expired

This Job is no longer accepting applications
Position Details:  
Client          Medical Device
Position      Regulatory Affairs Program Manager
Location     Roseville, CA 95678
Duration     6+ Months
Pay Range  $60-70/hr 

Job Description:
  • Accountability, this person should have a high say/do ratio and be able to work with other team members in a matrix to support business needs
  • Organizational skills, this person should be able to manage multiple interrelated projects simultaneously, identify critical path and propose multiple solutions to opportunities to crash schedules when needed. 
  • Stakeholder management, this person will be the “face” of the department within the Core Team and manage external stakeholders and support the department’s internal team through building a close relationship with a high level of collaboration.
  • This position will be responsible for coordinating the development of Technical Literature.  They will serve as the Core Team member, working cross-functionally to develop timelines and take content change needs back to the Technical Literature team for execution to meet the needs for human factors testing, regulatory submissions and product launches.  
  • This person will working closely with a matrixed team in the department consisting of graphic designers, project coordinators and technical writers to deliver high-quality technical literature to support the Diabetes Operating Unit.
Education Required: Bachelor’s Degree
Years’ Experience Required: 4+
 
 
Responsibilities may include the following and other duties may be assigned.
  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
  • Leads or compiles all materials required in submissions, license renewal and annual registrations.
  • Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
  • Monitors and improves tracking / control systems.
  • Keeps abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters.
  • Recommends strategies for earliest possible approvals of clinical trials applications.
DIFFERENTIATING FACTORS
  • Autonomy: Manages one or more small-scale, developed or mature programs with well-defined program plans and delivery methodologies. Is accountable for overall program process, performance, and customer satisfaction.
  • Organizational Impact: Provides input to establishing program objectives, timelines, milestones, and budgets. Recommends new policies and procedures that affect program management. May have budget accountability for one or more programs. Program decisions are generally made only after consultation with higher level management.
  • Innovation and Complexity: Problems faced are difficult, and require detailed information gathering, analysis and investigation to understand the problem. Problems typically impact multiple workstreams, departments or specialties . Modifies programs management processes to improve program.
  • Communication and Influence: Communicates and leads meetings with internal and external customers and vendors, conducts briefings to higher level management team. Solves issues through information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans.
  • Leadership and Talent Management: Leads, directs and reviews the work of a team of professionals and/or vendors who exercise latitude and independence in their assignments. Direct involvement in daily tasks necessary for successful program execution. Not directly responsible for hire or fire decisions and people management.
Required Knowledge and Experience: 
  • Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
  • Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.
  • Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A) and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
Job Requirement
  • regulatory affairs
  • technical writing
  • graphic design
  • project management
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Srividhya M
  • srividhya.m@collabera.com
This Job is no longer accepting applications
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Collabera is a leading global digital talent solutions firm. For over 25 years, we have provided digital and IT talent services, direct placement and career advisement, global remote talent and learning solutions to transform and diversify workforces for the Fortune 1000 globally.

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