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A BDN client is looking for a Pharmacovigilance Operations Manager to work in their office and report to the VP of Global Drug Safety. He/she would work alongside clinical operations and work through aggregate safety data in response to various queries and questions reported to them through their drug safety database. The consultant must have strong knowledge of PV within the clinical trial phase for medicines, experience with drug safety regulations, experience with data management and retrieval of data, and experience with vendor oversight.

A BDN client is looking for an Industrial Mechanical Engineer to come onsite to observe the process on the floor, develop a Value Stream Mapping, and specifically identify and target ROI opportunities they can start implementing. If this person demonstrates a full understanding with good insights, they may be asked to lead the ROI projects as the Project Manager or lead on the implementation. They would like to have someone with a Six Sigma Black Belt (preferred) with a degree and credentials. They do not need Medical Device experience, will look at Heavy industrial, Aerospace, etc.

A BDN client is looking for a Senior Manager of Regulatory Affairs to assist with the filing of 3 NDA's. This individual will support the regulatory leads on clinical projects, help with the development and implementation of regulatory strategy, development of supporting regulatory documents, and will also serve as the point person for regulatory authorities. Responsibilities include coordinating Regulatory submissions, Regulatory project management of US and EU regulatory submissions, with a focus on NDA's, orphan drug applications, and breakthrough designation requests.

A BDN client is looking for a Senior Director of Quality GCP who will be responsible for the strategic and operational management of the GCP Quality group and will ensure that the appropriate processes, systems, and activities are performed to protect the rights, safety, and welfare clinical patients. This individual will assess and directly work to continuously improve GCP quality processes; and support the state of GCP compliance.

A BDN client is looking for a Regulatory Affairs Consultant with 5-10 years of experience. The client has filled 2 INDs, so they need this consultant to assist the team on a part-time basis for Phase I and II routine IND maintenance and also guide the team on the steps that follow. It is very important that this professional has extensive involvement in the Biotechnology industry, has knowledge of drug efficacy, and early development experience.

A BDN client is looking for a Medical Director for Clinical Development. This individual will provide medical and scientific support within clinical development for products within the assigned therapy area (Rare Diseases – CMV infection post-transplant). They will also ensure that regulatory authority requirements and quality standards are met. This individual will review data generated in phase III trials, and provide oversight of the CRO medical monitoring and safety coding for client sponsored clinical research programs.

A BDN client is looking for a Regulatory CMC Consultant who will be responsible for supporting the CMC Regulatory Affairs team in developing, coordinating and implementing global CMC regulatory strategies for assigned programs and tasks. Specifically, the contractor is supporting the CMC Regulatory Affairs team in defining and optimizing global regulatory strategies pertaining to the development, registration, commercialization, and lifecycle management in the United States and international markets.

A BDN client is looking for a Senior Associate Scientist in Cell Line Development. This person will be generating stable CHO lines to enable the manufacturing of protein therapeutics. They will also be working with cell culture, clone screening, and cell banking. This individual should have experience in data management, analysis, and reporting to ensure the proper documentation and support for regulatory filings. Experience with mammalian cell culture, specifically suspension adapted CHO cells as well as Sterile technique experience in growing antibiotic-free mammalian cell cultures, is needed.

A BDN client is looking for a Clinical Program Manager for a 3-6 month temporary to perm opportunity. This person will facilitate study design by working with the Chief Scientific Officer. This is a highly visible role that will be responsible for designing, drafting, and establishing study protocols, case reports, informed consent reports, study master files, and other documentation for clinical studies supporting product development.

A BDN client is looking for a Software Quality Engineer for a 3-6 Months temporary to perm opportunity. This person will work with the engineering team to verify and validate software updates in compliance with the quality system. Some responsibilities include creating and executing document functional test protocols for new and existing software, maintaining product requirements, trace matrices and test reports, and identifying, analyzing, tracking, and documenting software defects.