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Fda Project Jobs in Crete, IL (NOW HIRING)

JLL

Senior Facilities Manager

Chicago, IL

Coordinate and oversee capital improvement projects, working with engineering teams, contractors ... FDA or other regulatory inspections * Strong technical knowledge of HVAC systems, clean room ...

Frontage Laboratories

Director of Toxicology

Chicago, IL · On-site

$150K - $200K/yr

Contribute to regulatory submissions and support audits/inspections (FDA, OECD, etc.). * Stay ... Track record of successful client engagement and project delivery Salary : $150k-$200k, annual ...

micro1 AI

Biostatistician

Chicago, IL · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

micro1 AI

Director of Biostatistics

Joliet, IL · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

micro1 AI

Biostatistician

Joliet, IL · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

micro1 AI

Director of Biostatistics

Chicago, IL · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

Sinai Chicago

RESEARCH TRIALS OFFICE MANAGER

Chicago, IL · On-site

Knowledge of FDA regulations governing clinical trials (21 CFR Parts 11, 50, 54, 56, 312, 314, 812 ... project management and organizational skills; ability to manage or oversee concurrent trials across ...

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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?

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 cities near Crete, IL are hiring for Fda Project jobs?

Cities near Crete, IL with the most Fda Project job openings:

Fda Project jobs near you

SAP Solution Director

Tata Consultancy Service Limited

Chicago, IL • On-site

$174K - $235K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 7 hours ago

Job description

Job Description:
We are seeking a visionary SAP Solution Director to lead the strategic design, implementation, and optimization of SAP solutions tailored for the Life and Health Sciences sector.
Responsibilities includes designing, developing, and delivering high-value SAP solutions that align with business objectives and customer needs. This is a critical role for consulting, and digital transformation projects.
The ideal candidate will possess a strong background in SAP systems, combined with deep knowledge of life sciences compliance and best practices.
Key Responsibilities:
• Strategic Leadership: Develop and execute the SAP strategy to support business goals in the life sciences industry, focusing on areas like clinical operations, regulatory compliance, supply chain management, and pharmaceutical manufacturing
• Solution Architecture & Design: Lead the design and deployment of SAP solutions (S/4HANA, SAP ECC, SAP ATTP, SAP EHS) that meet the unique needs of life sciences, ensuring alignment with FDA, EMA, and GxP compliance requirements.
• Client Engagement: Build and maintain strong relationships with key client stakeholders to understand their business needs and ensure customer satisfaction. Proactively identify potential business challenges and propose innovative SAP solutions to address them. Conduct presentations and demonstrations to showcase the value of SAP solutions to potential clients.
• Delivery & Execution Oversight: Oversee large-scale SAP projects, including implementations, upgrades, and validations, ensuring adherence to strict regulatory timelines and quality standards. Manage project budgets, timelines, and resource allocation to ensure successful project delivery. Collaborate with cross-functional teams, including business stakeholders, IT teams, and vendors, to facilitate smooth project execution.
• Regulatory Compliance & Validation: Ensure SAP systems comply with industry regulations such as 21 CFR Part 11, SOX, GDPR, and HIPAA. Lead computer system validation (CSV) efforts and audits.
• Cross-Functional Collaboration: Partner with R&D, clinical, regulatory affairs, manufacturing, and quality assurance teams to understand business needs and deliver tailored SAP solutions.
• Data Integrity & Security: Ensure robust data integrity practices and implement Application security frameworks to safeguard sensitive health and patient data.
• Continuous Improvement: Drive process improvements and digital transformation initiatives using emerging technologies like AI, IoT, blockchain for supply chain traceability, and predictive analytics in clinical trials.
• Team Leadership & Development: Build and mentor a high-performing SAP team, fostering a culture of innovation, compliance, and continuous improvement.
Key Skills/Knowledge Technical Skills:
• Strong knowledge of SAP modules (FI/CO, MM, SD, PP, QM, ATTP) and integration with ERP systems and other databases.
• Expertise in SAP S/4 HANA migration strategies and cloud-based SAP solutions.
• Knowledge of SAP integration technologies, ABAP development, and SAP UI5/Fiori
• Experience with Agile methodologies and digital transformation in life sciences.
Key Competencies:
• In-depth understanding of life sciences regulations and compliance requirements (FDA, EMA, GxP, HIPAA).
• Strong l eadership and project/program management skills with the ability to drive cross-functional teams in a highly regulated environment.
• Excellent analytical and problem-solving skills with a focus on data integrity and process optimization.
• Strong communication skills, with the ability to bridge technical and non-technical teams in complex projects.
• Strategic thinker with a focus on innovation, compliance, and business outcomes.
Experience Required
• 15-22 years of extensive experience with SAP lead business transformation in life and health science industry. Professional Certifications
• SAP Certified Application Professional (in relevant modules like SAP ATTP, SAP EHS, etc.)
• PMP or equivalent project management certification.
• ITIL certification is plus.
Qualifications: (Please list all required qualifications)
• Bachelors degree in information systems, Computer Science, Business Administration, or a related field.
• Masters degree preferred (e.g., MBA, Information System Engineering).
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
Salary Range: $174,300- 235,800 a year

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