Jobs in New Castle De Flexible

Trustpoint One is pleased to support a technology provider specializing in materials and components for semiconductor and electronics in its search for a contracts paralegal. The position will support the commercial legal team and have significant responsibility for managing legal risk proactively and efficiently. This long term temporary position offers hybrid flexibility in the Wilmington, Delaware office.

Contracts Paralegal Job Responsibilities:

- Review, draft, and amend routine contracts, consulting with a commercial attorney as necessary.

- Develop and update commercial contract templates and processes; instruct business clients in the use of the templates and processes.

- Assist in the preparation of more complex contracts.

- Conduct and summarize legal research.

- Gather, analyze, and prepare information for attorneys’ use in counseling the business.

- Provide guidance to the business on established legal, regulatory, and corporate policies

- and practices to facilitate compliance.

- Deliver education and training in response to specific business needs.

- Support product stewardship through research to assess risks and participation in product stewardship reviews; apprise attorneys of significant issues.

- Conduct legal review of literature, advertisements, and communications for the business.

- Support M&A activity through activities such as managing the collection, review, and organization of information responsive to due diligence.

Qualifications

- Four-year Bachelor’s degree, with a Paralegal Certificate from an ABA accredited or approved program or equivalent numbers of years related work experience.

- At least 5 years of experience as a paralegal

- Prior experience with drafting routine contracts.

- Familiarity with legal research tools, and the use of relevant databases.

- Willingness to adopt and use AI tools.

- Demonstrates high standards for professionalism, responsibility, and ethics.

- Demonstrates strong organization and investigative skills.

- Demonstrates ability to work and think independently, self-starter.

- Communicates effectively in writing and orally.

- Demonstrates a willingness to learn.

All candidates must be able to work on a computer screen for a sustained amount of time.

If you would like to learn more about the Contracts Paralegal in Wilmington, Delaware position please submit your resume in Word format.

Trustpoint.One provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Hi,

Hope you are doing fine and healthy !!!

I came across your resume. I have an immediate opportunity with our direct client.

Please let me know if you are available/interested so we can further discuss this position. Also email me your updated resume ( ) and share your best reachable contact number where I can call. You can also directly reach me on (732) 385-3706.

To know more about Integrated Resources, please visit us on this is an urgent business requirement, I’d appreciate a prompt response on this.

Title: CAPA Compliance Manager

Location: DE, Remote Role

Duration: 06+ Months

Time & Schedule: Monday to Friday

Pay Range: $75-90/hour on W2 (Based on Experience)

Job Description:

• CAPA Review Board - prepare material, generate data for charts (21 data sets / charts), analyze trends, provide talking points, load minutes and attendance to Agile.
• KPI Meeting - prepare material, generate data for charts (duplicates CRB except 2 NCE charts), analyze trends, and provide talking points.
• Process change orders for Corporate CAPA and NCE documents.
• Corporate CAPA and NCE procedures and work instructions.
• Agile-CAPA and Agile-NCE validation and specification documents.
• Administrative files for Agile-CAPA and Agile-NCE, e.g. Dropdown lists.
• Facilitating CAPAs and NCEs.
• Preparing and distributing quarterly Overdue CAPA/IACA report.
• Preparing and distributing monthly CAPA Aging report to QLT.
• Review and approving Agile access requests - CAPA, NCE.
• Periodic review of open COR, CAPA, and NCEs (globally).
• Validate and test Agile-CAPA and Agile-NCE tool changes.
• Author validation/specification documents for Agile-CAPA and Agile-NCE, e.g. SRS, SDD
• Maintain CAPA/NCE SharePoint page.
• Collaborate with AI team to establish AI proof of concept for identifying potential compliance issues in CAPAs.
• Ad-hoc data analysis.

If you are not interested in looking at new opportunities at this time I fully understand. I would in that case be appreciative of any referrals you could provide from your network of friends and colleagues in the industry. We do offer a referral bonus that I’d be happy to extend to you if they turn out to be a great fit for my client.

Thank you for your time and for your consideration. I look forward to hearing from you.

Job Title: Manufacturing Engineer

Location: Newark, DE

Duration: Long Term Contract

Client: Medical Device Industry

Our client is seeking an experienced Manufacturing Engineer to support remediation activities at its site Delaware site. This role is hands-on, floor-facing, and focused on stabilizing and remediating capital equipment manufacturing processes. The ideal candidate can step in on day one and work cross-functionally to assess process risk, validate controls, and ensure manufacturing processes are properly documented, mitigated, and executed in compliance with the Quality Management System.

Key Responsibilities

• Support remediation activities within manufacturing operations, with a focus on capital and electromechanical products

• Perform detailed process risk analysis, reviewing and scrubbing PFMEAs to ensure all process steps, failure modes, and mitigations are accurately identified and implemented

• Evaluate manufacturing processes end-to-end, confirming that identified mitigations are appropriate, effective, and reflected in procedures and work instructions

• Assess validation status across manufacturing processes, including IQ/OQ/PQ and Test Method Validation (TMV), ensuring downstream verification strategies are accurate and defensible

• Review and update manufacturing documentation, including procedures, work instructions, and DHF elements, to ensure alignment between documented processes and actual production practices

• Partner closely with Manufacturing, Quality, and Engineering teams to close gaps, implement corrective actions, and drive sustainable remediation outcomes

• Support manufacturing areas involving dimensional inspection, detection systems, and capital equipment, then expand remediation support across additional processes as needed

The Global Risk Management and Safety Surveillance (GRMSS) Portfolio Manager (Manager Level) is responsible for covering Pharmacovigilance (PhV) activities throughout products lifecycle management (other than Case management) for complete set-up, maintenance and closeout of programs. The position is responsible for ensuring global PhV oversight on pipeline trials, IST/IIRs, post-marketing programs and reporting requirements. The role is also responsible to streamline and standardize collaboration with Development Operations, Data Management, Regulatory Affairs, Medical Affairs and other departments as applicable, assisting with coordinating PhV responses for all compounds and products.

Essential Functions of the Job:

• Lead all PhV Project start-up, maintenance and closeout activities, including, but not limited to, Safety Reporting Plan review, safety database configuration/updates, regulatory submission impact analysis, training, as applicable, for clinical trials, IST/IIRs and post-marketing programs.
• Act as GPRM point person for key departments (e.g. Dev.Ops, Med. Affairs, Data Management, Reg. Affairs, Commercial).
• Departmental support for Portfolio oversight, including during Audits and Inspections.
• Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes.
• Coordinate GPRM efforts for new NDA/MAA/Product filing regulatory tasks, using the relevant checklist, as required.
• Organize GPRM cross-department training and brainstorming sessions for new programs and/or new products.
• Act as Subject Matter Expert (SME) with Business partners, PhV service providers and other CROs.
• Coordinate the development and maintenance of the global literature search strategy for his/her assigned product(s), per procedures.
• Contribute to the preparation and revision of INCY Periodic Safety Reports, as applicable.
• Facilitate the interactions with Clinical CROs at study and product levels and ensure accuracy of the Safety elements part of the contracts/agreements with these CROs.
• Train Portfolio Managers (Associate Manager level) and other GRMSS/GPRM staff, as appropriate.
• Assist with creating procedures (e.g. SOPs, Working Instructions, Job Aids), forms and templates, in support of efficient Project Management processes.
• Ensure compliance with internal procedures, regulatory requirements, and business partner agreements to ensure inspection readiness, at all times.
• Other responsibilities, as required and assigned by Senior management.

Qualifications:

• Master’s degree in Science or Healthcare related discipline, or equivalent.
• Minimum of 6 years Pharmacovigilance experience or other equivalent clinical or pharmaceutical experience.
• Minimum of 2 years Project Management experience or equivalent relevant experience.
• Experience in using safety database systems (Argus experience preferred).
• Good knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines and Good Clinical Practices.
• Excellent computer skills (i.e. Microsoft Word, Excel, Outlook, and Power Point).
• Excellent ability to work effectively within a team environment.
• Ability to create and deliver presentations.
• Excellent verbal and written communication skills.
• Fluency in written and verbal English.
• Travel (domestic and global) 5%.

Job Description

The Associate Director, Development Operations IT Business Partner leads the assigned business technology solution implementation, ongoing operational support, risk management, and relationship management for the Development Operations department. Reporting to the Senior Director, Development Operations Business Partner, the role serves as a business relationship link between the Development Operations organization and IT, and brokers business technology needs on behalf of the business area with the various leaders in the IT organization to design, implement, and continuously improve the business area’s technology portfolio. The role functions as a solution delivery specialist who leverages technology to improve the efficiency and effectiveness of our scientists and clinicians through the reliable use of technology tools.

Essential Functions of the Job

• Plan and direct the implementation, maintenance and support of systems and upgrades with 3rd party solution providers and Development Operations stakeholders. • Coordinate activities with the other IT teams as needed to provide seamless service to assigned business area. • Manage assigned resources appropriately so that project timelines and defined support objectives are met. • Perform technical/business analysis and prepare recommendations and business plans as needed. • Possess broad knowledge of most technical and business resources and use them to effectively coordinate team members and external resources. • Create consensus with other functions as to the timing of solution introductions and withdrawals. • Develop and implement solution frameworks, roadmaps, and strategies to ensure successful introductions across the organization. • Oversee the launch of solutions and maximize the positive impact on the organization. • Identify and evaluate new solution opportunities to address unmet internal and external customer needs. • Collaborate with other business and IT teams to ensure solution compatibility with company standards. • Manage direct report IT team (if applicable), including identification and development of staff. • Participate in strategic and budgetary planning processes. • Participate in the pursuit of new solutions and evaluate the applicability of and effectiveness of current solutions.

Required Skills & Experience

• Bachelor’s degree or equivalent business experience.

• 7+ years of IT and industry work experience in pharmaceutical or relevant life sciences environments.

• Must be an IT subject matter expert in the assigned business area with strong understanding of assigned business unit to include their business drivers for success, processes, and approaches to business models.

• Hands-on experience implementing any of the following industry leading technology platforms/solutions – Veeva Clinical Operations and Oracle Seibel CTMS – or familiarity with clinical Trial feasibility, recruitment and trial execution platforms.

• History of operational execution excellence, including management of relevant teams.

• Effective written and verbal communication skills to a variety of business and technical audiences. • Ability to establish and maintain strong relationships.

Salary: Up to $250,000

Exact compensation may vary based on several factors, including skills, experience, and education.

Accounting Manager - Fresno, CA

The Company:

An exciting opportunity in the Fresno area for Accounting professionals! A truly authentic independent insurance agency is looking to add an Accounting Manager. This firm is known for its approach to rewarding its employees with growth initiatives and continuous educational training sessions. Join an agency that puts clients and employees first.

The Benefits and Compensation:

• Annual salary ranging from $80,000 - $120,000, depending on experience
• The agency provides 100% benefits coverage, including medical, dental, and vision insurance
• Monday - Friday
• Flexible Schedule - Hybrid
• 401(k) plan with company matching contributions
• Paid time off and paid company holidays

The Preferred Qualifications:

• 8+ years of Accounting experience
• Accounting experience in an insurance brokerage is essential
• Bachelor's degree in Accounting, Finance, Business, or a related field.
• Proficient with AMS 360, Microsoft Office/Excel, accounting software, and agency management systems, etc.
• Extensive knowledge of Generally Accepted Accounting Principles (GAAP) and financial reporting.
• Demonstrated strong attention to detail, effective communication, and proven leadership

The Key Responsibilities:

• Foster continuous growth and improvement while overseeing accounting department operations.
• Proactively conducting regular audits to uphold compliance with statutory laws and financial regulations, contributing to the agency's stability and sustained growth.
• Oversee all accounts payable and receivable
• Generate comprehensive reports for management, offering key insights to drive strategic decision-making.
• Responsible for training and leading an Accounting team!

Apply Today!

Why Insurance Relief™?

As a businessperson in the insurance industry, it is an advantage to partner with a staffing expert and ally who understands your unique skills and needs. With vast experience in the insurance arena, Insurance Relief™ works with brokers, carriers, and third-party administrators to locate and place the best people for positions ranging from entry-level to senior management. We invest the time to truly understand what you want to accomplish and then do our best to find meaningful opportunities.

Insurance Relief™ provides ample opportunities for you to put your skills to work so if this position is not quite the fit for you please give us a call to hear about all of the other opportunities we have available.