Bioforce Solutions
Solutions for the Biotech Century
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BioStatisticians
Bioforce Solutions has current openings for BioStatisticians at several leading firms. Positions range from mid-level to senior-level. Responsible for all statistical aspects of pre-clinical through Phase IV clinical trials, including statistical analysis and design, protocol development and review, writing statistical contributions to clinical reports, creating reporting methods and guidelines, collaborating with programmers, investigators, physicians and medical writers. Play a key role in preparing research reports and NDA submissions for various drugs. All positions require experience with clinical trails and may require advanced degree in statistics. Oracle Clinical® and/or Clintrial® experience is a plus. We have roles across different therapeutic areas, including CNS, Oncology, Cardiology, and Respiratory.

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Clinical Data Managers
Bioforce Solutions has CDM openings at leading biotechnology firms and CRO's. Positions range from Data Coordinators to senior Clinical Data Managers. Main responsibilities include writing and integrating queries to validate clinical trails data with the goal of locking the database. Responsibilities can include management/allocation of workload amongst data management staff. Strong skills working with CRFs and DCFs are needed. Strong communication, documentation, and analytical skills are required. Bachelor's Degree with pharmaceutical experience is expected. Protocol review and CRF design experience may be preferred. We have permanent and contract roles across different therapeutic areas, including CNS, Oncology, Cardiology, and Respiratory.

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Clinical Data Programmers
Bioforce Solutions has CDP openings at several leading biotechnology firms and CRO's. Positions range from mid-level to senior-level. You will be invloved in database setup, build, and validation. CRF annotation, edit check validation, and creating of DCMs is a large portion of these roles. Strong communication and analytical skills required. SAS®, Oracle Clinical® and/or Oracle PL/SQL® experience is a plus. We have permanent and contract roles across different therapeutic areas, including CNS, Oncology, Cardiology, and Respiratory.

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Clinical Research Associates & Coordinators
Bioforce Solutions has CRA and CRC openings at leading national Biotechnology firms. Coordinate and perform comprehensive site management on one or more clinical protocols including telephone contact, documentation, and conduct of pre-study, initiation, interim, and closeout site visits. Monitor study protocols, including review of source documents, case report forms, regulatory documents, informed consents, investigational product, clinical supply accountability, AE/SAE reporting, and transmittal of CRFs. Ensure immediate reporting of any serious adverse events related to the study project. Update and maintain internal training records, SOPs, calendars, and time and expense reporting as requested. Coordinate and advise project team on status of task completion and site activity. We have permanent and contract roles across different therapeutic areas, including CNS, Oncology, Cardiology, and Respiratory.

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Statistical Programmers - SAS
Bioforce Solutions has Statistical Programming openings at leading national Biotechnology firms and CRO's. Positions range from mid-level to senior-level. Responsible for programming with SAS to generate tables, listings, and figures for protocol reports and NDA submissions. Using SAS to analyze clinical data from CRFs, creating SAS data sets for analysis, and report writing for clinical trials (pre-clinical through Phase IV), generating efficacy and safety reports Generating reports using PROC Tab, PROC Report, Data Null, SAS® arrays, PROC SQL and Macros, and verifying and documenting programs. Strong SAS® programming experience is required, and degree in statistics is a plus. We have permanent and contract roles.

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Quality Engineers
Bioforce Solutions has Quality Engineer openings at leading biotechnology and medical device firms. Positions range from mid-level to senior-level. Design and resolution of risk analysis plans, validation and design control functions are expected tasks for these positions.  This position will require the candidate to utilize strong engineering and quality control experience to validate and improve the product.

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Regulatory Affairs Professionals - FDA
Bioforce Solutions has Regulatory Professionals at leading Biotechnology and medical device firms. Positions range from mid-level to senior-level. Responsible for coordinating and preparing IND and NDA submissions while serving as internal regulatory consultant and FDA liaison throughout the product development, submission, pre-approval, launch, and post-marketing phases. You may need a degree in Life Sciences or related field and 5 years pharmaceutical industry experience (QA/QC/Regulatory), with a minimum of 3 years in Regulatory Affairs. Knowledge of FDA regulations/guidelines, technical writing expertise, and excellent organizational and communication skills.

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Validation Engineers - FDA
Bioforce Solutions has openings for RA Professionals at leading national Biotechnology firms. Positions range from mid-level to senior-level. Responsible for review of systems and projects containing software and associated documentation to ensure the alignment of company SOPs with FDA Guidance Documents. Also coordinate and execute IQ, OQ, and PQ validations for process systems. Working knowledge of cGMPs and their documentation. Experience with QA compliance associated with clinical systems and biologics manufacturing is also needed. Roles with CSV and CFR 21, Part 11 are available. Knowledge of FDA regulations/guidelines, technical writing expertise, and excellent organizational and communication skills are required. We have permanent and contract roles.

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Process Engineers - FDA
Bioforce Solutions has Process Engineering openings at leading national Biotechnology firms. Positions range from mid-level to senior-level. Creation of specification, design, and operational support of process equipment and manufacturing systems for pharmaceutical cGMP production facilities. This position will work with the Manufacturing, Validation and Quality groups in leading design reviews of process equipment. Experience in the design and operation of BioPharma production lines is required. Roles may require programming experience with AutoCAD®, PLCs, and leading HMI/MMI products in an FDA-regulated environment. We have permanent and contract roles.

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Drug Safety Associates
Bioforce Solutions has Drug Saferty Associate openings at leading biotechnology firms. Positions range from mid-level to senior-level.  Processing of adverse drug experiences and technical complaints for both marketed and investigational drugs while assuring compliance with regulatory requirements and established Standard Operating Procedures (SOPs). Respond to medical and technical questions regarding the company's products including writing comprehensive and accurate medical and safety information to health care professionals and consumers with minimal supervision.  Generate appropriate written reports pertaining to potential adverse drug event (ADE) or safety issues for marketed and investigational products.  Perform investigation and follow-up functions for Adverse Event Reports as well as prepare safety reports for the FDA.

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