The Associate, Regulatory Affairs Labeling and Artwork (remote position): • Supports all aspects ... with FDA, GMP, ISO and other applicable standards and regulations. • Coordinates and prepares ...
The Associate, Regulatory Affairs Labeling and Artwork (remote position): • Supports all aspects ... with FDA, GMP, ISO and other applicable standards and regulations. • Coordinates and prepares ...
The Associate, Regulatory Affairs Labeling and Artwork (remote position): · Supports all aspects ... with FDA, GMP, ISO and other applicable standards and regulations. · Coordinates and prepares ...
The Associate, Regulatory Affairs Labeling and Artwork (remote position): · Supports all aspects ... with FDA, GMP, ISO and other applicable standards and regulations. · Coordinates and prepares ...
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Senior Clinical Project Manager
Salt Lake City, UT · On-site +1
$165K - $211K/yr
... FDA, ICH, GCP regulations and guidelines Working Location & Compensation ... This position is open to both remote and hybrid models. The hybrid position would be office‐based ...
Senior Clinical Project Manager
Salt Lake City, UT · On-site +1
$165K - $211K/yr
... FDA, ICH, GCP regulations and guidelines Working Location & Compensation ... This position is open to both remote and hybrid models. The hybrid position would be office‐based ...
Senior Clinical Project Manager
Salt Lake City, UT · On-site +1
$165K - $211K/yr
... FDA, ICH, GCP regulations and guidelines Working Location & Compensation ... This position is open to both remote and hybrid models. The hybrid position would be office‐based ...
Remote Fda Contract information
What are the key skills and qualifications needed to thrive as a remote FDA contract specialist?
To thrive as a Remote FDA Contract Specialist, you need expertise in contract management, regulatory compliance, and a solid understanding of FDA procedures, often supported by a degree in law, business, or a related field. Familiarity with contract management software, federal acquisition systems, and relevant certifications like CFCM (Certified Federal Contracts Manager) is typically required. Exceptional attention to detail, strong negotiation skills, and effective communication are crucial soft skills for this role. These competencies ensure accurate, compliant contract execution and foster strong working relationships with stakeholders while meeting federal regulations.
What is the difference between Remote Fda Contract vs Remote Fda Investigator?
| Aspect | Remote Fda Contract | Remote Fda Investigator |
|---|---|---|
| Credentials | Typically requires a background in regulatory affairs, life sciences, or related fields; may need FDA-specific certifications | Requires a background in clinical research, regulatory science, or life sciences; often needs FDA investigator certification or related credentials |
| Work Environment | Contract-based, remote or onsite depending on project; project-specific roles | Primarily remote or onsite inspections, audits, and investigations for FDA compliance |
| Employer & Industry Usage | Used by pharmaceutical, biotech, and medical device companies for regulatory compliance projects | Used by FDA and contract agencies for conducting inspections and investigations |
Remote Fda Contract roles focus on regulatory projects and compliance consulting, often contract-based and project-specific. Remote Fda Investigators conduct inspections and investigations to ensure FDA compliance, often requiring specific certifications. Both roles are vital in the regulatory landscape but differ in responsibilities and work settings.
What are some common challenges faced when working in a remote FDA contract role, and how can they be managed?
Remote FDA contract roles often involve navigating complex regulatory requirements while collaborating with cross-functional teams in a virtual environment. One common challenge is effective communication, as remote work can sometimes lead to misunderstandings or delays in feedback. To manage this, it's important to establish clear communication channels and regular check-ins with team members. Additionally, staying updated with evolving FDA guidelines and maintaining organized documentation are critical for compliance and project success. Leveraging project management tools and fostering a proactive, detail-oriented mindset can help ensure deliverables meet regulatory standards and deadlines.
What is a remote FDA contract?
A Remote FDA Contract refers to a job or project agreement where an individual or company provides services to the U.S. Food and Drug Administration (FDA) or related organizations from a remote location, rather than working onsite. These contracts often involve regulatory consulting, compliance documentation, project management, or data analysis to help clients meet FDA requirements. Remote FDA contractors may work independently or as part of a remote team, and they are expected to stay updated on FDA regulations and guidance. This role offers flexibility in location and hours but requires strong communication skills and a thorough understanding of FDA standards.
What cities in Utah are hiring for Remote Fda Contract jobs? Cities in Utah with the most Remote Fda Contract job openings:
Full-time
Posted 16 days ago
Job description
Our Regulatory Affairs team brings essential generic quality medicines to U.S. patients by providing Regulatory leadership and establishing regulatory systems and processes that support Civica's mission.
The Associate, Regulatory Affairs Labeling and Artwork (remote position):
• Supports all aspects of product labeling and artwork development, review, approval, implementation and maintenance for Civica's private label distribution (PLD) products.
• Follow labeling and artwork procedures that comply with FDA, GMP, ISO and other applicable standards and regulations.
• Coordinates and prepares Office of Prescription Drug Promotion (OPDP) submissions as needed.
• Works within systems to maintain labeling and artwork.
• Owns or impact assesses change controls for PLD labeling impact.
Responsibilities Include:
• Coordinate labeling and artwork design by an external vendor
• Collaborate with the supply chain, contract manufacturers, packagers, and external vendors to ensure timely implementation of approved labeling changes.
• Maintain labeling and artwork records within applicable electronic systems and document repositories.
• Support preparation and submission of Office of Prescription Drug Promotion (OPDP) materials, as needed.
• Maintain FDA drug listings information and associated regulatory records.
• Participate in change control activities as a change owner, contributor, or impact assessor, as appropriate, to evaluate and implement labeling-related changes.
• Review labeling components and artwork for accuracy, consistency, completeness, and compliance with approved regulatory content.
• Ensure labeling information included in regulatory submissions is complete, accurate, and consistent.
• Support continuous improvement initiatives related to labeling processes, systems, and workflows.
• Perform any other tasks/duties as assigned by management.
What we look for:
We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue doing what is in the best interest for our patients.
Technical Skills;
Proven experience in critically reviewing documents for consistency and accuracy. Excellent proofreading/editing skills are required.
Strong organizational skills.
Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strives to continuously improve and build knowledge and skills.
Teamwork:
Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Inspires respect and trust.
Quality Management:
Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
Education Minimum Requirement :
Bachelor's degree required, focus in Life Sciences preferred.
Required Experience and Skills :
At least one to two 2+ years of relevant experience within the pharmaceutical regulatory environment, with a concentration in pharmaceutical labeling and/or artwork development or promotional review.
Physical demands of the position include only those required for work in a typical office environment. Minimal travel (0-5%) may be necessary in the execution of the listed duties
About Civica Rx
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
51 - 200 Employees
Headquarters location
Lehi, UT, US
Year founded
2018