Fresenius Kab Jobs (3)

Job Summary

The Senior Manager, Regulatory Advertising and Promotions (Biosimilar) position is responsible for the review and oversight of all marketing and sales training materials that constitute advertising and promotional activities for US Biosimilar marketed products.

The position is responsible for the management, of timely submissions of all advertising and promotional materials to the FDA.

Interprets and administers policies, processes and procedures necessary for the review and approval of marketing and sales training materials in collaboration with the market unit.

Maintains effective working relationships with legal, Medical Information and Safety, Marketing, and RA teams. Participates in management discussions, provides strategic guidance including supervisory responsibility of any direct reports for Ad Promo review, compilation and submission according to FDA regulations.

The ideal candidate will work hybrid out of our Lake Zurich, Illinois corporate office. Qualified candidates remote to the area will also be considered.

Responsibilities

Review and approve advertising and promotional materials, corporate and other non-promotional materials as applicable, for all US marketed products-primarily Biosimilars;

support other pharmaceutical drug products as needed.

• Oversight could also include AdPromo materials for in licensed products as well as partnership products where Fresenius Kabi holds the application but doesn’t market.
• Responsible for operational leadership to ensure compliance with current FDA regulations and expectations and consistency in regulatory decisions concerning marketing materials.

Decisions include appropriateness of materials, amount of safety information, eligibility for submission, bundled strategies, multimedia materials, etc.

• Assume a leadership role in advising cross-functional stakeholders on the regulatory impact of new campaign concepts and may also be required to provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications
• Develop regulatory strategy and Fresenius Kabi philosophy around advertising and promotional materials for biosimilar products.
• Providing regulatory intelligence and education on emerging regulations and trends in the Advertising and promotional space including reviewing and interpreting enforcement letters specifically for biosimilar products.
• Provides comments and perspective on proposed regulations.
• Anticipates changes in the regulatory environment and the potential impact to Fresenius Kabi, shaping internal strategies accordingly
• Influence and obtain buy-in from peers and co-workers when reviewing and approving materials.
• Prioritize workload based on the Marketing unit needs and work together with the technical submissions manager to ensure timely and complete submissions.
• Develop process for tracking of OPDP submissions to improve operational efficiency and potentially reduce review time on future materials
• Managing and prioritizing the team's workload in accordance with departmental goals
• Helps staff to interpret changing priorities, processes and requirements,
• Leads the development of procedure or tools to increase work efficiencies
• Anticipate peak workloads and resource accordingly
• May provide direct supervision of individuals including mentoring, performance management and staffing decisions.
• Motivating staff and maintaining the team's focus on departmental objectives
• Translates strategic goals into group and individual performance objectives
• Motivates and encourages by recognizing accomplishments and providing feedback

Requirements

• Bachelor’s degree in life sciences / medical discipline.
• 6 or more years related experience in the pharmaceutical industry, including but not limited to regulatory affairs experience.

People Management experience a plus

• 4 plus years’ experience in US regulatory affairs advertising and promotional review
• Thorough understanding of US regulations for drug promotion / advertising and experience in the regulatory review of prescription drug advertising and promotion including product launches for biologic / biosimilar products.
• Demonstrated effective written and verbal communication skills, attention to detail, and superior organization skills
• Demonstrated experience in working with others collaboratively to achieve organizational objectives including the ability to lead and influence decisions, anticipate and adapt, work tactics to support changing business needs
• Proven ability to analyze and interpret efficacy and safety data
• Proficient in standard business software applications and an aptitude for electronic systems and software.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

The Manufacturing Engineer will use technical expertise in support of daily operations in aseptic filling or formulation by defining, measuring, analyzing, coordinating, implementing and follow-up concerning projects and activities designed to increase or improve safety, quality, productivity, and / or capacity.

Apply accepted engineering practices and project management techniques to assigned daily tasks and projects. Analyze situations, break them down into key components and milestones, conduct fact-finding missions, provide detailed plans of action, and implement plans as assigned.

Responsibilities

Develops systems to identify and measure key performance indicators (uptime, downtime, scrap, yield). Identifies key site capacity constraints and provides timely solutions to resolve.

Uses Lean tools to measure, understand, and improve process variability and efficiency. Manages related capital projects adhering to budget and schedule constraints.

Provides on-going technical support for manufacturing operations in aseptic filling or formulation. Analyzes daily production and processing problems, identifies and implement shop-floor continuous improvement projects.

Establishes engineering tracking tools and enforce their usage through fact driven communication between all stakeholders (e.

g., operations, maintenance, quality, engineering, technology center, suppliers, etc.).

Coordinates maintenance and drive technical activities for cGMP compliant manufacturing improvement Works with production personnel to establish or revise work instructions and procedures used in the production environment.

Ensures timely completion of the tasks and support as assigned by management. Maintains awareness of current pharmaceutical manufacturing needs and standards and communicates possible programs / projects to achieve the goal of facility being a state-of-the-art pharmaceutical manufacturing site.

Coordinates activities of various vendors for projects to eliminate any potential conflict and assures that vendors comply with all the safety rules and regulations.

Prepares URS, Risk Assessments, Safety Assessments associated with the support of and execution of projects. Prepares specifications for projects to include all dimensions, electrical, HVAC and mechanical considerations.

Works effectively with Operations and Quality to ensure project results are compliant with site and industry regulations and guidelines.

Responsible for maintaining and constant improvement of the ISO 50001 energy management system. Identify energy savings opportunities and make recommendations to achieve more energy efficient operation.

Monitor and analyze energy consumption.

Requirements

• Bachelor’s degree in Engineering (Electrical, Chemical, Controls, Computer, Mechanical, etc.).
• 1-3 years plant manufacturing experience.
• Understanding of control systems and PLC programming of highly automated manufacturing technologies (Siemens / Allen Bradley).
• Understanding of S88 standard batch programming (PCS7, Plant PAX, Delta V) preferred.
• Ability to coordinate and support contractors or team members as assigned.
• Excellent verbal and written communication skills (technical writing and presentation)
• Working knowledge of AutoCAD or SolidWorks preferred.
• Must be able to work independently and set priorities.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsible for order fulfillment activities at the Market Unit Distribution Center including all functional areas of distribution operations and warehousing.

This includes but not limited to Receiving; Put-away; Replenishment; Customer Order Fulfillment; Dock Activity Shipping;

Inventory Cycle Counting; Sanitation and Maintenance, daily assignments to support these activities, and other duties in greater or lesser degrees as determined by supervisory staff.

Responsibilities

Accurately pick customer orders according to product code, lot number, and quantity requested and move completed orders to packing lines.

Report any discrepancies and / or damages to the Supervisor. No substitutions of product or lot number are permitted without Customer Operations authorization.

When applicable, document and check picked orders for accuracy of lot numbers, quantities.

Accurately pack customer orders in compliance with instructions on the order form or as provided by the ERP system

Pack completed orders in such a manner as to protect the product from loss or damage.

Process parcel shipments using the provided Ship Station Meters. Palletize metered packages for transfer to the appropriate carrier and mode of shipping (ground or air).

For LTL palletized shipments; scan, palletize cases, weigh and stretch-wrap truck orders. Create and print BOL, packing slips, label pallet as required, and accurately stage truck order for shipping.

Loading and unloading of trucks as assigned.

Supports inventory cycle counts as required by Inventory Control.

Observe all safety guidelines; inform Supervisor of any safety hazards; attend all required safety training classes.

Able to operate material handling equipment as necessary to move materials while complying with all safety and power industrial truck operating rules.

Must achieve and consistently maintain warehouse KPI’s and performance goals / expectations.

Responsible to learn all applicable Standard Operating Procedures and be fully compliant with all regulations regarding the handling, storage, and shipping of Dangerous Drugs and Medical Devices.

Responsible to understand and comply with all Company policies and procedures by accessing computer-based training.

Cleans, maintains and ensures proper housekeeping in the facility to meet and exceed GMP requirements.

Adhere to all Good Documentation Practices (GDP) standards.

Responsible for additional projects and duties as assigned by Supervisor.

REQUIREMENTS

High School Diploma or GED

1-3 years’ experience in a warehouse role with working knowledge of all functional areas of the warehouse is preferred.

Some SAP (or equivalent systems) knowledge and RF Scanning is preferred; ability to learn these systems quickly is required.

Knowledge of Microsoft Office products with spreadsheet applications (Excel) skills is a plus.

Solid mathematical and reading skills.

Effective problem-solving skills including demonstrated use of sound judgment, good organizational skills, time-management skills and the ability to work in a team-oriented environment.

High level of attention to detail.

Must be able to work in a fast-paced, deadline-orientated environment.

Capable of learning and being proficient on Powered Industrial Truck (PIT), including, but not limited to, walkie-riders, cherry pickers, deep reaches, and sit-down forklifts.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.