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 | Location  | City | Job Type | Job Title | Category | Status |  |
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| IL | Lake Forest | Permanent | Clinical Programmer | Clinical | Open | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Sr. Statistical Programmer
Position Description
- The purpose of this position is to provide study-level statistical programming suppor
- Executing analysis deliverables to meet the requirements of clinical studies.
- Enforcing standardization of derived datasets and analysis outputs to maximize global data integratability.
- Directing the work of external vendors providing statistical programming services to achieve quality and timely, cost-effective study deliverables.
Position Responsibilities - Represent the statistical programming function in support of assigned clinical studies
- Define and manage derived data set and reporting standards for common clinical studies using respective company standards.
- Develop, execute, and maintain routine SAS computer programs according to Statistical Analysis Plans (SAPs) or analysis requests to: Produce statistical analysis output (tables, listings and graphs) to support generation of critical (flash) clinical study results or ad-hoc analyses involving descriptive statistics; Perform standard data manipulations, including creation of derived data sets, related to the production of the statistical output; Verify (QC) simple study analysis results or derived data sets produced by another statistical programmer, statistician, or an external vendor.
- For assigned common clinical studies, identify vendor requirements and participate in the evaluation/selection of Analytical Sciences vendors. Provide technical oversight of statistical programming activities of external vendors to assure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical programming vendor deliverables. Seek advice of senior peers, the manager, or the study statistician, if needed, in overseeing the vendor activities and review of outputs.
- Manage transfers of all externally produced analysis data and outputs.
- Archive statistical outputs and related documentation according to company standards
- Anticipate and communicate resource and quality issues that may impact deliverables or timelines. Escalate issues to senior peers or management as appropriate and implement solutions.
- Support implementation of programming utilities, data and output standards and improvements to the statistical programming environment.
- Comply with all applicable regulatory requirements,standards and procedures.
Position Requirements - BS in Statistics, Computer Science, or other related field with minimum 2years SAS programming experience in the pharmaceutical/CRO industry; or MS in Computer Science, Statistics, or other related field with minimum 1 year SAS programming experience in the pharmaceutical/CRO industry.
- Good knowledge of SAS programming language and Base SAS, SAS/GRAPH parts of SAS software, knowledge of simple procedures in SAS/STAT.
- Good understanding of general programming and computing principles, experience with Windows NT and UNIX operating systems, and common software products and technologies used in conjunction with SAS; working knowledge of office software (Microsoft Office).
- Understanding of clinical study documents (protocol, CRF, SAP, Clinical Study Report).
- Understanding of clinical study designs, common analysis methods, descriptive and simple inferential statistics, and data presentation practices.
- Understanding of data management processes, including EDC processes, documents and data flow in clinical trials.
- Basic understanding of drug development process.
- Knowledge of FDA and ICH regulations and industry standards applicable to clinical study data and reporting on clinical trials, including data standards for electronic submissions.
- Basic project management skills.
- Good oral and written communications skills.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | IL | Morton Grove | Temporary | Clinical Quality Assurance | Clinical | Open | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Manager, Quality Operations
Position Description
- The management of the Label Control area and personnel to ensure that labeling material needed for filling and packaging are stored, issued and returned per SOPs.
- The management of the Incoming Inspection area and personnel in inspecting and releasing incoming materials, including but not limited to Raw Materials, Components, Printed Material and Returned Goods.
- The management of the In-process Quality Assurance area and personnel in performing in-process checks during compounding, filling and packaging.
- The management of the Batch release area and personnel involved in review and release of product to commerce and placing product on hold.
Position Responsibilities
- Ensures the Label Control Clerk is performing duties which are compliant to SOPs and cGMPs including but not limited to storing, issuing and return of printed material.
- Coordinates with Regulatory Affairs to ensure current labeling revisions are correct and when current revisions are depleted from inventory.
- Coordinates with Material Management Department to ensure the labeling material is available for Filling and Packaging to produce product.
- Ensures Inspection activities being performed by the Incoming Inspector are compliant with SOPs and cGMPs including but not limited to Inspection, Sampling and Release of Raw Materials, Printed Material, Components and Returned Goods.
- Performs review of Manufacturer’s COA to the QCTR and performs other Incoming Inspection duties within the department in order to meet deadlines.
- Manage the QA In-process department to ensure scheduling and planning needs are met.
- Audit the daily activities in the manufacturing area to ensure compliance with cGMPs and SOPs.
- Work closely with manufacturing, packaging and Maintenance departments to assure quality production results and to ensure compliance to SOPs and cGMPs.
- Manages the Batch Release Department in the review of batch documentation in order to release Finished Product into commercial inventory.
- Responsible for the update of departmental SOP’s and reviews of batch records.
- Reviews documentation for accuracy and compliance to Good Documentation Practices.
- Train new employees and review job performance of current employees.
- Ensures employees are properly trained prior to them performing their job responsibilities.
- Responsible to perform review of SOPs, Packaging Component Specifications and Raw Material Specifications every two years
Responsible for investigating or aiding in the investigation of deviations that occur within the department or that are related to incoming material. - Responsible for responding to Internal Audit observations
- Other duties as assigned by Quality Management
Position Requirements - College Degree in Life Science or Engineering.
- 5-10 years of Management experience in Pharmaceutical Industry.
- Ability to work well with other departments.
- Excellent Communication Skills.
- Computer literate with working knowledge of Microsoft Office and Microsoft Access.
- Strong Time Management and multi-tasking abilities.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | IL | Cary | Temporary | Quality Control | Scientific | Open | | | Candidate will perform chemical and physical analysis of products using HPLC, UV, and FTIR in cGMP environment. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Candidate will perform chemical and physical analysis of products using HPLC, UV, and FTIR in cGMP environment.
- Document findings and generate test reports as needed.
Position Responsibilities - Conduct Quality Control testing as well as microorganism identification and growth promotion tests.
- Perform routine chemical and physical analysis of components, raw materials and final pharmaceutical products and stability sample using HPLC, UV, and FTIR.
- Capture, by means of thorough and clear documentation, all pertinent information required/expected to verify the reliability of test results.
- Respond/react to the detection of testing anomalies and deviations in operation or procedure (performing instrument and method troubleshooting, generating justification rationales, initiating investigations, etc.).
- Assist with reviewing / approving instrument outputs, lab records and test reports; aid in execution of studies and protocols
Participate in routine instrument maintenance as assigned. - Experience with current Good Manufacturing Practice (cGMP) or Quality System Regulation (QSR) desired.
Position Requirements - Bachelor’s degree with emphasis in science or a comparable amount of actual laboratory experience.
- Must possess very good communication and computational skills as well as sound math and basic algebra skills.
- Experience with operating common laboratory instrumentation and equipment, particularly HPLC.
- Physical Demands: Standing, walking, sitting, lifting, carrying, etc.
- Must be capable of accurately discerning instrument read-outs or displays. Good color discrimination.
- Must posses appropriate manual dexterity for lab operations. Maximum lifting height 6 feet.
- Occasionally exerting up to 50 pounds and routinely up to 10 pounds.
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| | | IL | Deerfield | Temporary | Delta | | Open | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Medical Director, Clinical
Position Description
- Identify, assess and appropriately manage safety signals Phase 1- Phase 4.
Position Responsibilities
- Review safety reports and safety sections for labels. Possess familiarity with biostatistics and computer data processing techniques. Must have strong interpersonal and leadership skills, self motivation, integrity, ethics and a solid commitment to drug safety.
- Review and evaluate serious event reports
- Communicate safety assessments
- Medical review for safety sections of protocols, study reports, labels and investigator brochures.
- Work with Quality Assurance, Document Management, Clinical teams, Legal,and Regulatory Affairs
Position Requirements - Associate Director- 1 to 3 years of clinical experience within a private practice or academic medical setting.
- Medical Director- 2 years of drug safety experience:
- Senior Medical Director requires 5 years.
- MD/DO board certified in internal medicine or family medicine is preferred.
- Clinical pharmacology or clinical trial experience is also preferred.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | IL | Round Lake | Permanent | Scientist | Scientific | Open | | | Delta Scientific is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description - The position is responsible for directing studies involving multiple departments and techniques within PK and Bioanalytical Sciences.
Position Responsibilities - Management of other scientists
- Maintenance of laboratories and instruments
- Designing novel assays
- Validating analytical methods
- Authoring reports
- Design and conduct pharmacokinetic/toxicokinetic studies, along with in vitro and in vivo metabolism studies, to support the strategy for development of departmental programs.
Position Requirements - A strong background in pharmacokinetics is required.
- This person will be utilizing pharmacokinetic software (e.g, WinNonlin, NOMEM etc).
- PhD in pharmaceutical sciences, biochemistry, organic chemistry or related area with a minimum 2 years, or MS/MA in a related field with at least 5 years experience will be preferred
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| | | IL | Melrose Park | Permanent | Manufacturing | Scientific | Open | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Responsibilities - Calibrates instruments according to SOP’s.
- Keeps orderly, accurate, and accessible records of calibration maintenance and repair procedures performed on all instruments in compliance with cGMP/cGLP requirements.
- Distributes to Product Development Management, Quality Control Management, and/or the department’s responsible supervisors, the department’s monthly calibration schedule generated from the Blue Mountain Calibration Manager database.
- Evaluates calibration intervals on new and existing equipment to reflect the risk assessment based upon the calibration history or the manufacturer’s recommendations.
- Ensures that the metrology group’s standards, tools, and other equipment are securely stored. Ensure all equipment, manuals, tools, etc. are properly returned to the delegated storage at the end of the day.
- Expertise in the maintenance, operation, and troubleshooting of laboratory analytical equipment.
- Prepares instrument calibration and preventive maintenance SOP’s for new and existing instruments.
- Initiates, assigns, and investigates incident deviations within the Trackwise database.
- Troubleshoots malfunctions and performs repairs on lab instruments as needed.
Position Requirements - Must have a minimum of a 2-year Associate’s Degree in Electronics, or Science related field, plus 2-5 years of experience in a regulated environment.
- Must be familiar with concepts of metrology as applied to the pharmaceutical industry.
- Experience with laboratory instrumentation.
- Proficient Interpersonal skills.
- Proficient Communication skills.
Proficient reading and writing skills. - Attention to detail.
- Familiarity with computers.
- Proficient in the area of problem solving.
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| | | IL | Morris | Temporary | Lab Technician | Scientific | Open | | | Perform QC Technician functions designed to direct the different manufacturing units in order to make process changes by using standard analytical methodology to quantify the equality of the products produced in the units. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Perform QC Technician functions designed to direct the different manufacturing units in order to make process changes by using standard analytical methodology to quantify the equality of the products produced in the units.
- Analyzes test data to support production activities.
Position Responsibilities - Perform routine quantitative and qualitative analysis to determine chemical and physical properties of products and related raw materials
- Utilize various chemical analytical (wet analysis) techniques and instrumental techniques (GC, HPLC, FTIR, etc)
- Perform standard procedures to calibrate instruments, standardize titrants, and make reagents / indicators
- Record and distribute data to various areas as specified by procedure, as applicable
- Perform non-routine analyses
- Trouble shoot analytical instruments
- Trouble shoot GC instruments under the guidance of an instrument chemist
- Trouble shoots GC instruments with under the guidance of instrument chemist
Review typical analysis of products using SAP
Position Requirements - BS degree in Chemistry
- A strong knowledge and proficient in using the QM module in SAP
- Two years of relevant experience working in the Surfactants industry. A strong background in Nitrile and Amine technologies is a plus.
- Strong computer knowledge, especially in Excel
- Ability to work well in teams
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| | | IL | deerfield | Permanent | Clinical Medical Writer | Clinical | Open | | | The Medical Writer III is responsible for the coordination, preparation, and completion of Periodic Adverse Drug Reports (PADERs), Periodic Safety Update reports (PSURs), and other ad hoc safety documents for submission to regulatory agencies around the world. The Medical Writer III is also a team leader providing guidance in safety writing procedures and training. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Medical Writer III - PSUR
Position Description
- The Medical Writer III is responsible for the coordination, preparation, and completion of Periodic Adverse Drug Reports (PADERs), Periodic Safety Update reports (PSURs), and other ad hoc safety documents for submission to regulatory agencies around the world. The Medical Writer III is also a team leader providing guidance in safety writing procedures and training.
Position Responsibilities - Assist in the management of safety writing report timelines, resources, and project workload
- Assist in the training of safety writing team members, providing functional expertise and guidance
- Write and prepare standalone postmarketing aggregate safety documents for regulatory submission, such as PSURs and associated documents, and PADERs
- Ensure all safety regulatory documents are processed and submitted according to regulatory requirements
- Ensure data issues are addressed and resolved prior to document sign-off
- Facilitate document review by other contributors
- Assist with the creation and maintenance of standardized departmental procedures concerning the writing of Safety reports and processing of the reports for regulatory submission
- Participate in ongoing safety data review and analysis for products in designated therapeutic areas
- Collaborate with medical reviewers, epidemiology, and risk management concerning safety issues relative to safety writing activities
- Interface with other functional groups such as Regulatory Affairs, Quality, Information Technology, business units, as needed
- Lead or participate in project teams and committees as assigned
- Act as therapeutic area team leader
- Demonstrated leadership in a team environment
- Experience preparing postmarketing safety regulatory documents such as PSURs and associated documents, and PADERs
- Knowledge of global postmarketing safety reporting regulations and guidances
- Experience with coding dictionaries such as MedDRA
- Excellent scientific writing skills
Position Requirements - Bachelor’s degree in a medical / scientific field plus at least four (4) years pharmacovigilance experience, or a Master’s degree plus at least two (2) years pharmacovigilance experience
- Previous experience writing PADERs and/or PSURs
- Exposure to a working relationship with FDA and other regulatory authoritiesmeeting expectations of regulatory authorities for aggregate safety reports
- Experience writing in an academic research, clinical research, scientific/analytical, or medical affairs setting is a plus
- Proficiency for the following competencies are key to success in the Risk Management Group.
- Scientific and Technical Analysis - Provide Guidance to internal project teams in the area of design and analysis for more complex or high risk projects
- Submission Project Mgmt – Provide direction and guidance to more junior staff in response to complex AE reporting and content, documents, timeline
- Product/Process Quality Standards - Oversee the education of internal stakeholders on implications of regulations
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | IL | Waukegan | Permanent | Chemist | Scientific | Open | | | The primary function of this position is to provide analytical chemistry support to manufacturing and R&D departments. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- The primary function of this position is to provide analytical chemistry support to manufacturing and R&D departments.
Position Responsibilities - Approve batches, incoming raw materials, and routine analysis of the different samples to classify their physical and chemical identity.
- Must be able to perform analysis from the following analytical equipment: FTIR, GC, HPLC, KF-TITRATOR, REFRACTOMETER, scales, oven, pycnometer, etc.
- Maintain all analytical equipment according to the schedule and Standard Operating Procedures.
- Complete all paperwork related to the analysis (Calibration Log, Finished Goods Log, Raw Materials Log, ETC.)
- Ensures that all work meets applicable QA/QC guidelines.
- Validation and development of analytical methods, also validation of manufacturing equipment, production lines and products.
- Review and update test methods and procedures according to SOP.
- Prepare reports to document findings and recommendations.
- Coordinate with personnel in other disciplines to integrate findings and recommendations.
- Must be have computer skills (Word, Excel and instrumentation software)
- Strong interpersonal, writing, and multi-tasking skills with the ability to work in a team.
- The Chemist reports directly to the Director of Technical Services.
Position Requirements - BS Degree in Chemistry or Equivalent
- A minimum of 2 years related professional experience
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| | | IL | Westmont | Permanent | Information Technology | Information Technology | Open | | | Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together. Come be a part of our success story!
Job Title
Position Description
- This is an exciting opportunity to drive the design and development of innovative software products. You will decipher customer needs, translate these needs into requirements, and define functional specifications for clinical software. You will work with life sciences industry experts and a world-class software engineering to transform complex needs intotangible software solutions. de Post Sales Account Management to CTMS customers. Strong understanding of CTMS systems is critical, with a background in clinical research.
Position Responsibilities/Experience - 4+ years of business analyst experience working in an end-user environment, software product management, or consulting role within the pharmaceutical, biotechnology, medical device, or CRO industries
- Demonstrated success understanding the business issues and data challenges of a individual client and or markets and translating these into well defined business requirements and functional specifications
- Hands-on experience working closely with development and engineering teams through a product life-cycle process
- Strong working knowledge of one or more of the following disciplines - project management, budgeting, financial forecasting, costing, or business analytics, BI systems
- Experience with clinical trial systems (CTMS, EDC, etc.) and clinical trial processes
- Experience with Agile development methodologies
- Experience defining data integration/API requirements and specifications
- Have a passion for technology and be a self-starter who enjoys new challenges
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | IL | Westmont | Permanent | Clinical Management | Clinical | Open | | | Provide Post Sales Account Management to CTMS customers. Strong understanding of CTMS systems is critical, with a background in clinical research. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Clinical Services Manager
Position Description
- Provide Post Sales Account Management to CTMS customers. Strong understanding of CTMS systems is critical, with a background in clinical research.
Position Responsibilities
- Support the development and implementation of key projects.
Manage, maintain and serve as primary contact for existing customer relationships; - Develop and execute on account strategies
- Identify/confirm the customer’s business needs/drivers
- Identify other potential users (ex. expansion opportunities)
- Identify potential inside competition (ex. systems, initiatives, dissenters, re-organizations)
- Identify consult needs and lead the delivery of Study Consult Services (SCS) to customer
- Expand understanding and use of company’s software within existing customers, including customer’s Executive team
- Identify new opportunities within existing customers (i.e. new products) and secure referrals to other opportunities
Position Requirements - BS/BA degree plus 5 years direct pharmaceutical clinical research experience (primarily as a CRA/Clinical Trials Manager and/or Clinical Operations Manager)
- 5+ years experience in clinical operations, clinical trial project management, clinical trial costing, and/or clinical outsourcing/contract negotiation
- Strong entrepreneurial drive and ability to deliver results with limited supervision
- High energy, self-motivated, assertive; consummate professional
- Good customer presence and presentation skills
- Able to understand/analyze customers [unstated] needs.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | IL | Melrose Park | Permanent | Scientific Project Manager | Scientific | Open | | | Delta Scientific is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Quality Assurance Manager
Position Description
- This position will be responsible for establishing, implementing, and maintaining Quality Systems SOPs and Analytical Test Methods related to technical transfer activities associated with the manufacturing integration of over 100 SKUs. The candidate will be responsible for review and approval of analytical data, product technical transfer protocols, stability studies etc. and will manage analytical investigations (equipment, stability, out of specification (OOS).
Position Responsibilities
- This role will focus on technical and operational quality decisions associated with product transfer actives such as: leadership skills, self motivation, integrity, ethics and a solid commitment to drug safety.
- Approving and auditing test method transfers / verifications
- Approving and auditing stability data
- Approving and auditing technical transfer protocols and final reports
- Approving technical transfer related documentation (e.g., SOPs, Master Batch Records, and Investigation Reports etc.
- The position will be working directly with the technical transfer team and site staff to integrate the products on time and on budget.
Position Requirements - Review and approve analytical data package for API, finished drug products and stability
- Write, review, and approve SOPs, test methods, specifications, protocols, reports, and other documentation related to QC and analytical testing
- Perform a comprehensive review and assessment of stability data (e.g., OOS investigations)
- Prepare stability sections for regulatory/QC documents in support of PASs and CBEs
- Manage with site staff the qualification/validation of analytical methods, approval of validation protocols and reports, specifications, batch records and changes related to methods and specifications
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| | | IL | Round Lake | Permanent | Clinical Quality Assurance | Clinical | Open | | | Delta Scientific is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Product Surveillance Nurse
Position Description
- This position is responsible for managing in-depth complaint investigations, with expert product knowledge. This role is responsible for report submissions to regulatory bodies and providing information to Baxter business units for decision-making purposes. This position is a subject matter expert in the team and will train and mentor other Product Surveillance Quality Associates. Infusion pumps and dialysis products.Both U.S. and global review.
Position Responsibilities
- Process high-risk (Death/Serious Injury) complaints without supervision
- Determine reportability of a complaint and submit associated Medwatch reports within 30 days per regulations
- Lead the investigation, including developing investigation plan, defining members of investigation team and their roles and responsibilities, plan on-site visits, follow-up communication with internal and external customers
- Travel to customer sites to obtain information pertinent to the investigation, including sample, clinical and engineering information
- Guide Specialists leading high-risk investigations, review Medical Device Reports associated with death and serious injury
- Produce and maintain annual base line reports, Alternative Summary Reports and 24-Month Reports as required by the Medical Device Reporting regulation Perform trend reporting and escalate results to appropriate business units for consideration of necessary actions
- Represent Product Surveillance on Product Improvement Teams, as well as CAPA.
Position Requirements - Expert knowledge of the FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 806, 820 and 211.)
- Understanding of regulations governing markets outside the U.S. Expert understanding of the product’s intended use and manufacturing process of assigned products
- Bachelor’s degree in Nursing or Medical Technology is required
- 7 years experience, which should include Product Surveillance, direct clinical/medical experience, or relevant product/technical expertise
- Experience managing CAPA is preferred
- 5% travel
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| | | IL | Melrose Park | Permanent | Scientist | Scientific | Open | | | This position is responsible for formulation development. Lyophilization experience is required and degrees in Pharmaceutics or Chemical Engineering are preferred. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- This position is responsible for formulation development. Lyophilization experience is required and degrees in Pharmaceutics or Chemical Engineering are preferred.
Position Responsibilities - Responsible for completing developmental studies and to ensure that products can be manufactured to generate acceptable stability data for FDA drug application.
- Accepts responsibility for all stages of product development including on-site monitoring of stability lot manufacturing.
- Plans, develops, and implements scientifically well-designed experimental designs to meet project objectives as well as meeting corporate and GMP requirements.
- Identifies the multidimensional aspects of complex problems and applies novel and creative solutions to problems. Capable of handling the most complex projects with only general guidance.
- Participates in the orientation and training of new lab employees in the proper execution of research and development experiments and is responsible for supervising one to two lab staffs.
- Responsible for product and process improvement as well as for ideas for new products, line-extent, product stability improvement and novel drug delivery systems.
- Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule and is further accountable for the use of his/ her time for creative, self initiated research.
Position Requirements - Must have a Ph.D. as well as three years or more of related experience, or MS degree with seven years plus related experience.
- Must possess skills of designing and executing experiments, analyzing experimental results, and solving problems.
- Must have knowledge of pharmaceutical dosage forms, as well as concepts in developing novel drug delivery systems.
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| | | IL | Waukegan | Temporary | Manufacturing | Scientific | Open | | | The Compounder position is responsible for maintaining chemical inventories and doing basic QC testing. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- The Compounder position is responsible for maintaining chemical inventories and doing basic QC testing.
Position Responsibilities - Hot and cold blends.
- Maintain chemical inventories.
- Create batches - Blend & fill.
- Basic QC testing - ph, color matching, specific gravity, etc.
- Complete batch reports.
- Report problems to management.
Position Requirements - Must be bilingual Spanish/English
- Must have blending/compounding experience.
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| | | IL | St. Charles | Temporary | Quality Control | Scientific | Open | | | QC Inspector will be conducting quality checks on incoming and outgoing products and testing raw samples. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- QC Inspector will be conducting quality checks on incoming and outgoing products and testing raw samples.
Position Responsibilities - Weigh products for accuracy and will be required to work in the food blending department as needed.
- Inspect lines to ensure all products are meeting proper guidelines.
- Match customer product specifications to assure clients SOP’s are being met.
- Conduct quality checks on packaging, products, labels and codes and perform other tests include pH, taste and proper weights
- QC Tech will be required to enter all found data onto company data programs.
Position Requirements - A High School degree or GED Equivalency is required.
- Must be able to work 2nd shift (10 hour shifts) and able to work over time when needed.
- Bilingual in Spanish is preferred.
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| | | IL | Deerfield | Temporary | Clinical Research Associate | Clinical | Open | | | Responsible for coordinating and managing contracted homecare services in the support of sponsored projects and Phase 1 – IV clinical studies in a variety of therapeutic areas. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Responsible for coordinating and managing contracted homecare services in the support of sponsored projects and Phase 1 – IV clinical studies in a variety of therapeutic areas.
Position Responsibilities - Excellent communication skills (written and verbal)
- Well organized and able to multi-task
- Excellent problem solving skills
- Positive and energetic attitude
- Able to perform at a high level, producing quality results in the desired timeframe
- Able to work well independently or as a Team member
- Takes initiative while following directives
- Proficient computer skills, including word processing (i.e. Word), spreadsheets(i.e. Excel), email and calendaring (i.e. Outlook)
- Minimal, if any, travel anticipated
Position Requirements - Bachelors Degree, preferably in the life sciences or healthcare field
- Clinical research experience strongly preferred
- Homecare experience preferred
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | IL | Lake Forest | Temporary | Clinical Drug Safety Specialist | Clinical | Open | | | Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed product. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Ensure effective and accurate collection, database entry, review and reporting of safety data.
- Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed product.
- Assist in signal generation and safety analysis activities
Position Responsibilities - QC review and follow-up assessment of local safety case reports.
- QC of expedited reporting submission documents for case reports.
- Ensure quality of case processing/reporting by providing feedback to Case Processing group.
- Review of local/global case reports to determine regional reportability.
- Represent pharmacovigilance department in cross-functional teams or committees that have global study or program impact.
- Assist with narrative writing for periodic/ad hoc submissions.
- Assist with ad hoc or routine safety monitoring activities.
Position Requirements - Registered nurse or Bachelors degree required; scientific/medical field preferred
- Minimum 2 years experience in healthcare, clinical or pharmacovigilance-related area.
- Experience with safety databases including simple searches & coding dictionaries (MedDRA) is desired.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | IL | Deerfield | Temporary | Miscellaneous Clinical | Clinical | Open | | | Responsible for the local logistical/tactical project management activities as determined in the Core Team strategy. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Responsible for the local logistical/tactical project management activities as determined in the Core Team strategy.
- Have close interaction with the Global Development Project Leader as well as the Global Project Management Leader to implement local development activities including project budgets and timeline, specifically managing the logistics of critical path work plans essential to optimize development time and the time to registration and launch of new global products.
Position Responsibilities - Member of the Core Team, providing leadership of local project management and managing the logistics of critical path work plans essential to execute the Global Development Strategy that will ensure an efficient development from FS (close to PDAP) till Registration.
- Reviews development plans at all milestones, identifies project risks and supports resolving project issues.
- Constantly monitors the local progress of the project, will pro-actively take actions to improve the efficiency and reports the progress to the TA GDPL.
- Obtains resources for the local project team with sufficient quality to execute the development plans.
Position Requirements - Bachelors degree is mandatory with an advanced degree (PhD or PharmD) preferable. Total management experience including line/project management. Multidisciplinary program management experience, which includes leadership in more than one IND/IMPD, NDA/MAA, Advisory Committee or other PMDA/EMEA/FDA meetings.
- Minimum of six (6) years experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology.
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | IL | Deerfield | Temporary | Clinical Medical Writer | Clinical | Open | | | Sr. Level Medical writer will be working on IND submissions. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Sr. Level Medical writer will be working on IND submissions.
Position Responsibilities - Writing regulatory documents including, IND, NDA, IBs, Briefing Documents
Position Requirements - Bachelors Degree, preferably in the life sciences or healthcare field
- Experience writing INDs (greater than 4)
- Ability to work onsite
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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