Find a Job

A BDN client is need of a Batch Record Review consultant to come on board for 6 months to review and release batch records and work diligently to help their clients to get their product out the door. The client is a liquid and oral solid dose producer, but aseptic sterile experience would also be valued. This is strictly paper-based batch records so having experience there is important. The client uses JD Edwards for their inventory management system so having experience with JD Edwards is a PLUS. A Bachelor's Degree in a relevant field is preferred for this position.

A BDN client is looking for a Quality Engineer with no less than 2-4 years of experience and technical experience in science or engineering. This professional will support the implementation of a product stewardship database and ensure part, packaging and product information is accurately tracked in the database. They will ensure compliance with geography-specific restricted substance requirements (e.g., RoHS, REACH, EU MDR). This Quality Engineer must have experience with facilitating, tracking and working with various groups on component changes in the manufacture, import, and distribution of any new product or relocation of manufacturing processes.

A BDN client is looking for a Clinical QA Consultant to fill in while their employee is on leave. This person will be assigned to the clinical quality team to provide guidance to a study team in terms of quality and regulatory expectations. He/she will need to know clinical regulations globally for executing clinical studies and how to apply those regulations. This individual must have a Bachelor’s Degree with 8+years of relevant work experience in the GCP space. They must also have a heavy pharmaceutical background and a well-rounded personality for this position.

A BDN client is looking for a Regulatory Affairs Consultant who has experience leading the process of writing Pre-IND meeting requests and packages, IND/ CTA submissions, and understanding of CMC (Module 3) requirements for IND submissions. As a member of the Project Team, he/she will work closely with Managers and the VP of Regulatory to solve challenging client questions. The consultant will also own assigned analyses and workstreams, develop and deliver components of the client engagement, and contribute to the success of each project. A Bachelor's Degree in a scientific field is preferred for this role.

A BDN client is looking for an IT Project Manager with a good understanding of infrastructure projects. He/she will be managing tasks and not staff. Project Management experience is more important than the technical background. 5-10 years of IT PM experience, including systems development life cycle experience, is desired. Managing end-to-end project plan and budget across multiple responsible parties (i.e., BAs, development teams, both internal and external, business leads, testing teams, third-party service providers, etc.) is essential. A Bachelor or Advanced Graduate degree/s in Information Technology/Business solutions or general business or life sciences is needed.

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. This person will also collaborate with the Global Clinical Development Lead, Clinical Scientists, Global Program Lead and Clinical Operations to ensure that all development and product support activities for the therapeutic area(s) are coordinated and consistent.

A BDN client is looking for a PV scientist with around 2-3 years of experience to provide strategic collaboration and safety expertise, including support for regulatory submissions and responses, aggregate reports, white papers, etc. This scientist will have a big part in assisting with writing/reviewing aggregate reports (PSUR / DSUR), including the risk management plans. The client stated that this scientist’s experience can be from either industry or academia and that there is no preference in their therapeutic background. A Bachelor's Degree is required for this position. An advanced degree or specific pharmacovigilance qualification is preferred (MD, Ph.D., and PharmD).

A BDN client is looking for a Regulatory Affairs Consultant. He/she will provide expertise and guidance for clients that are developing new technology. The client is looking for candidates with 3-5 years of experience in a regulatory role in devices, biotechnology, or combo products. The consultant should have experience writing submissions such as 510k, PMAs, de novo 510ks, and IDEs. Excellent communication and interpersonal skills with client service orientation are essential. A Bachelor's Degree in a scientific discipline is desired for this position.

A BDN client is looking for a Clinical Development Scientist. The consultant will be responsible for providing scientific support for their clinical research and product development initiatives. He/she will help with the preparation of clinical output summaries, clinical data presentations, trial synopses, and patient profiles, as well as provide clinical scientist input on regulatory questions. This person will also help in the preparation of targeted reviews, and assist the medical monitor in the review of trial data and development, as well as review clinical study documents and reports.7-10 years of clinical research experience within the pharmaceutical industry or a CRO is required.

A BDN client is looking for a Quality Systems Consultant. This individual should have device and some regulatory compliance experience to write SOPs, interpret regulatory documents, handle change controls, review their existing templates, support, and maintain their existing quality management system. He/she will need to maintain support functions and programs for domestic and international quality and regulatory compliance; per applicable standards and regulations i.e., 21 CFR Part 820, ISO 13485, ISO 14971, and In-Vitro Diagnostic Regulation. Providing expertise to the following functions/activities; CAPA management, lead internal & external audits, procedure development, and modification, product labeling, metric development, and reporting, management of external standards is needed.