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Regulatory Affairs Program Manager

Remote: 
Full Remote
Contract: 
Salary: 
106 - 144K yearly
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

Bachelor’s Degree required, 4+ years of relevant experience, Experience in Graphic Design and Technical Writing preferred.

Key responsabilities:

  • Coordinate development of Technical Literature
  • Direct preparation of document packages for regulatory submissions
  • Manage stakeholder relationships within the Core Team
  • Monitor and improve regulatory tracking systems
  • Recommend strategies for regulatory compliance
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IntePros SME https://www.intepros.com/
201 - 500 Employees
See more IntePros offers

Job description

Compensation Range:

$55 to $75 hr D.O.Q

Welcome to IntePros, a certified woman-owned company specializing in innovative and results-oriented recruiting and staffing solutions. We take immense pride in genuinely understanding what drives and inspires exceptional individuals like you. Your success is our priority, and we are dedicated to actively shaping your long-term career journey. At IntePros, we believe in comprehensive well-being. You have access to our medical, dental, vision, and mental health programs, ensuring your health and wellness are taken care of. To support your continuous growth, we also provide a $1,500 per year education and professional certification fund. Diversity and inclusion are cornerstones of our company ethos. IntePros is proud to be an equal opportunity employer. We do not discriminate in employment on the basis of race, color, religion, sex, pregnancy, gender identity, national origin, sexual orientation, disability, age, veteran or military status, retaliation, or any other characteristic protected by law. We celebrate the rich tapestry of backgrounds and perspectives that make us stronger as a team. Please note that only qualified individuals being considered will be contacted. We appreciate your interest and look forward to potentially embarking on a transformative journey together.

Program Manager -

Contract Role

W2 Only

Yearlong contract to start

HM's Top Needs:

  • 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.


4, Experience with Graphic Design and Technical Writing Background a big plus

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.

PROGRAM MANAGEMENT CAREER STREAM: Program Managers and Directors focus on tactical, operational activities for a major program with broad or ongoing impact. Levels within the program management career stream typically accomplish program objectives through matrixed employee teams and / or vendors who are not direct reports but for which the incumbent has direct accountability to lead. The majority of time is spent overseeing their area of responsibility, managing program/team performance, communicating project and operational developments, planning, prioritizing and / or directing the responsibilities of program team members. Goal achievement is typically accomplished through performance of program team members.

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.


Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Organizational Skills
  • Accountability
  • Program Management
  • Leadership
  • Problem Solving
  • Communication
  • Collaboration

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