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Fda Project Jobs in Florida (NOW HIRING)

QualityHub

Project Manager Administrator

Orlando, FL · Remote

Our services include addressing complex situations like FDA warning letters, product recalls, and ... Role Overview This Project Manager Administrator is responsible for providing day-to-day support ...

Tech Tammina LLC

Sr. Project Engineer

Boca Raton, FL · On-site

$93K - $122K/yr

Position: Sr. Project Engineer Location: Boca Raton, FL Status: Full Time, Permanent ... FDA submissions as required. * Create capital expenditure requests and purchase requisitions for ...

Tech Tammina LLC

Sr. Project Engineer

Boca Raton, FL · On-site

$93K - $122K/yr

Position: Sr. Project Engineer Location: United States, , Boca Raton Status: Full Time, Permanent ... FDA submissions as required. * Create capital expenditure requests and purchase requisitions for ...

Tech Tammina LLC

Sr. Project Engineer

Boca Raton, FL · On-site

$93K - $122K/yr

Position: Sr. Project Engineer Location: Boca Raton, FL Status: Full Time, Permanent Category: No ... FDA submissions as required. * Create capital expenditure requests and purchase requisitions for ...

ARTHREX

Project Manager II- Marketing

Naples, FL · On-site

... FDA guidelines. 6. Supports development of standard project and program management processes and tools as well as executive reporting of project status, risks and issues 7. Conduct project post ...

ProMach

Project Manager

Tampa, FL · On-site

Knowledge of packaging machinery regulatory standards (FDA, ISO, CE Mark) a plus. * Familiarity with Lean manufacturing a plus. * PMP, PRINCE2, or other project management certifications are a plus.

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Fda Project information

What is an FDA Project?

An FDA Project typically refers to a project that involves compliance with the U.S. Food and Drug Administration (FDA) regulations. These projects can include developing, testing, or bringing to market medical products such as drugs, medical devices, biologics, or food items. The goal of an FDA Project is to ensure that products meet safety, efficacy, and quality standards set by the FDA before they are approved for public use. Such projects often require extensive documentation, clinical trials, and regulatory submissions to obtain FDA approval.

What is the difference between Fda Project vs Fda Reviewer?

AspectFda ProjectFda Reviewer
Required CredentialsTypically requires a background in life sciences, engineering, or related fields; often includes project management certificationsRequires a degree in life sciences, pharmacy, or medicine; often needs FDA-specific training or experience
Work EnvironmentProject teams within pharmaceutical or biotech companies, regulatory agencies, or consulting firmsRegulatory agencies, pharmaceutical companies, or biotech firms reviewing submissions
Employer & Industry UsageUsed in project management contexts to oversee regulatory submissions and complianceUsed in regulatory review processes to evaluate drug, device, or food applications

In summary, Fda Project roles focus on managing regulatory initiatives and ensuring compliance within organizations, while Fda Reviewers are responsible for evaluating and approving submissions directly for regulatory approval.

What are the key skills and qualifications needed to thrive as an FDA Project Manager, and why are they important?

To thrive as an FDA Project Manager, you need a strong background in regulatory affairs, project management, and a degree in life sciences or a related field. Familiarity with FDA submission requirements, electronic common technical document (eCTD) systems, and project management tools like MS Project or Asana is essential. Excellent communication, organization, and problem-solving abilities help manage cross-functional teams and ensure compliance. These skills ensure that projects meet regulatory standards, progress efficiently, and achieve timely FDA approvals.

What are some common challenges faced by professionals working on FDA project teams?

Professionals working on FDA project teams often encounter challenges related to regulatory compliance and shifting guidelines. Navigating complex documentation requirements, coordinating with cross-functional teams (such as clinical, regulatory, and quality assurance), and meeting strict submission deadlines are all common hurdles. Effective communication and adaptability are essential, as projects frequently involve collaboration across departments and ongoing updates based on regulatory feedback. Successfully managing these challenges helps ensure product approval and supports career advancement within regulatory affairs.
What are popular job titles related to Fda Project jobs in Florida? For Fda Project jobs in Florida, the most frequently searched job titles are:
What job categories do people searching Fda Project jobs in Florida look for? The top searched job categories for Fda Project jobs in Florida are:
What cities in Florida are hiring for Fda Project jobs? Cities in Florida with the most Fda Project job openings:
Fda Project jobs near you

Project Manager

ADMA BIOMANUFACTURING LLC

Boca Raton, FL • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 17 days ago

Job description

Project Manager
Job Description:
Position Summary:
The Project Manager will manage projects by analyzing information, developing, and tracking project plans, providing expertise to resolve project difficulties, and directing resources.
Essential Functions (ES) and Responsibilities:
  • Assist in the management, planning and tracking of activities for multiple project teams across products, functions and sites. Develop schedules and performance requirements. Responsible for ensuring project goals are met on time.
  • Ensures effective, accurate and timely communication across functional areas within the project / program, serving as a primary point of contact among functional areas for project / program-related issues.
  • Interact frequently with outside partners, project team members and senior staff to ensure cooperation and achievement of common goals.
  • Analyze company goals in relation to project tasks in order to balance new and existing projects. Facilitate project and product development teams by:
    • Determining project team composition and preparing organizational charts.
    • Evaluating appropriate sources for project information and dissemination of information as appropriate to relevant employees and outside partners.
    • Analyzing resources and priorities to be applied to assigned projects.
    • Analyzing information in order to prepare and update project plan timelines.
    • Assessing project activity; identifying and resolving potential project complications.
    • Facilitating problem solving and consensus building.
  • Identify and implement best practices in order to facilitate standardization and coordination across disciplines, functions and/or programs.
  • Present technical information to senior staff concerning specific projects, schedules, budgets, etc.
  • Inform management of progress and potential challenges in a timely manner.
  • Enhance project management skills at ADMA; educate and support ADMA project managers managing smaller, local projects on the efficient use of project management tools (MS Project/Smartsheet).
  • Educate ADMA project team members across all functions on how to actively and efficiently contribute to projects.

Education & Experience Requirements:
  • Education Requirements: Bachelor's degree in science, engineering, or business.
  • Experience Requirements: Five years' experience in a biopharmaceutical environment including: laboratory, manufacturing, engineering, quality assurance etc.

Compliance Requirements:
The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
Job Description Footer:
In addition to competitive compensation, we offer a comprehensive benefits package including:
  • 401K plan with employer match and immediate vesting
  • Medical, Vision, Life and Dental Insurance
  • Pet Insurance
  • Company paid STD and LTD
  • Company Paid Holidays
  • 3 Weeks' Paid Time Off (within the first year)
  • Tuition Assistance (after the first year)
  • Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
ADMA Biologics is an Equal Opportunity Employer.

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