
Description: The Clinical Supplies Label Operator will, with limited supervision execute assembly operations for labeling clinical supplies based on issued assembly records in accordance with company SOPs and cGMPs. In order to do so, they will collaborate with Clinical Supplies Managers, the Clinical Supplies Floor Supervisor, Clinical Supplies Label Coordinator, and Inventory Technician such that they deliver quality study supplies that meet both project and regulatory requirements. Principal ...
Jun 12 - Skillman

Description: The Clinical Supplies Floor Supervisor will, with limited supervision, plan for, schedule, and oversee assembly operations for labeling clinical supplies based on issued assembly records in accordance with company SOPs and cGMPs. In order to do so, they will collaborate with Clinical Supplies Managers, Clinical Supplies Label Coordinator, Inventory Technician, and Clinical Supplies Label Operators such that their team delivers quality study supplies that meet both project and regulatory ...
Jun 12 - Skillman

Description: The Inventory Control and Distribution Technician will, with limited supervision: • Support Clinical Supplies projects in the areas of receiving, distribution, return, and destruction. • Receive product into inventory, coordinating inspection of incoming goods as appropriate. • Collaborate with Clinical Supplies Managers, the Clinical Supplies Floor Supervisor, and internal customers to achieve on-time delivery of clinical supplies that meet both project and regulatory requirements. ...
Jun 12 - Skillman

Qtech Internship program develops technical skills and knowledge pertaining to roles and responsibility to be performed as Business Analysts towards Clinical Research and Safety Reporting / Financial Risk and Credit Banking / Medical Healthcare Claim / Insurance and System Analyst with clients: Internship includes prior training, which follows real time experience and exercise learning pattern. Educational Qualifications: Bachelor Degree or Higher in Business Management / Computers / IT Only students ...
Jun 11 - Somerset

Qtech-Sol Internship program develops technical skills and knowledge pertaining to roles and responsibility to be performed by Clinical Research Associates and Clinical Research Monitor. Internship includes prior training, which follows real time experience and exercise learning pattern. Training is required and may take 1.5 months to complete. Internship takes approximately 2 months depending on project needs. The students will be selected and toward ONE of the career pathways for learning. ...
Jun 11 - Somerset

Qtech Internship program develops technical skills and knowledge pertaining to roles and responsibility to be performed as SAS programmer towards Clinical Research / Financial Banking / Risk / Credit / Healthcare Claims / Adjudication Analysts with clients. Training is required prior to the internship. Internship is provided for 3-6 months depending on the project and performance during initial training. The students will be selected and qualified for one of the career pathways for learning. ...
Jun 11 - Somerset

Qtech-Sol Internship program develops technical skills and knowledge pertaining to roles and responsibility to be performed as Drug Safety Associates. Before the internship the professional training is required, which provides real time experience and exercise learning pattern. Educational Qualifications: Bachelor Degree or Higher in Life Science Preferred degree in: Anatomy, Biochemistry, Biotechnology, Biology, Biomedical Science, Biomedical Engineering, Chemistry, ...
Jun 11 - Somerset

Regulatory Affaris II Term: 03/31/2014 Raritan, NJ 08869 Job Description: Review and facilitate signing of documents including Power of Attorney, Letters of Authorization, etc. by internal and external partners, follow by tracking of notarization/legalization and shipment. Track documents throughout the process and resolve issues related to delays or lost requests. Ensure documents are completed and arrive at affiliates before due dates. Significant amount of contact with international markets ...
Jun 7 - Raritan

My name is Erica and I represent The Fountain Group. We are a national staffing firm and are currently seeking someone for a Regulatory Affairs II position with a prominent Fortune 500 client of ours. The position is located in Raritan, NJ. If the position sounds like it may be of interest to you, please respond with an updated resume and acceptable salary range. Job Description: · Review and facilitate signing of documents including Power of Attorney, Letters of Authorization, etc. ...
Jun 6 - Raritan

Regulatory Affairs Document Coordinator Consulting Project Somerville, NJ [email removed] | 646.790.8355 Title: Regulatory Affairs Doc Coordinator III Description: The RA Document Coordinator will be responsible for the coordination and compilation of technical documentation to support regulatory applications in the EU (Technical Files, Design Dossiers) and US (510(k), BLA, PMA, IDE, IND, Annual Reports). The RA Document Coordinator will also be responsible for maintaining, organizing, and ...
Jun 6 - Somerville

Must have written: NDA submissions, Protocols, Narratives, Case Report Studies, and Inform Consent forms Description: The Senior Medical Writer researches, creates, and edits all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other departments and clients to set and meet internal and external deliverable timelines. Write clinical documents for submission to regulatory authorities, including ...
Jun 3 - Bridgewater

Job Title: Safety Surveillance Associate 1 year contract On-site daily in Client, NJ Specific Therapeutic Area: Candidate required to have experience in Oncology. Position Purpose: Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pharmaceuticals products and to meet regulatory requirements. Primary Responsibilities: Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting ...
May 28 - Bridgewater

We have a client in need of a Statistician in the Bridgewater, NJ area. This is a contract opportunity with the possibility of becoming permanent. Requirements: University degree (MSc, PhD) in Statistics, Mathematical Statistics or Biostatistics, or equivalent experience. Prior clinical trial experience with a comprehensive knowledge of Clinical Drug Development processes and ability to and ensure compliance with regulatory authorities, quality and technical standards. 3+ years of statistical ...
May 23 - Bridgewater

Company: Pharmaceutical Company Location: Northern NJ Status: Direct hire The Clinical Study Manager will ensure that clinical strategies are translated into operational line with clinical development plans. In particular they will align operational execution activities with agreed upon project priorities, timings and quality specifications and adhere to all relevant regulations including GCP, ICH and PhRMA guidelines, Regulatory requirements, and Company SOPs and policies. The incumbent will be ...
May 17 - Bridgewater

Supply planning responsibilities for assigned product lines including MRP planning and scheduling within Company operating procedures and policies. • Supports the data management process to consolidate key External Ops data across the sector, including demand history, supply history, inventory trending, as well as other key supply chain metrics. • Analyze this supply chain data/metrics to determine risks, watch-outs and opportunities. • Maintains External Operations performance scorecard. • ...
May 9 - Bridgewater

Job Title: Plastic and Cosmetic Surgery Sales Summary Description: Responsible for executing a sales plan to introduce American CryoStem’s services to existing and new clients. Sales manager will be directly responsible for American CryoStem’s internal and external sales team. The sales manager will also be familiar with and implement the ACS marketing plan and use all resources that are available and sanctioned by ACS. The sales manager will be assisted by in house support teams for the ...
May 9 - Eatontown

Summary Description: Ph.D. level scientist to oversee and advise the Company regarding its laboratory operations, review and write SOPs, and initiate research in related areas. The Company provides services for referring physicians and patients involving the cryopreservation of adipose tissue as well as the processing of adipose tissue for the isolation, expansion, and cryopreservation of adipose stromal cells (ASC; adult stem cells) and related media for clinical uses. The individual will oversee ...
May 8 - Mount Laurel

Responsibilities: • This position supports North America Scientific & Clinical Purchasing with contract coordinating for new contracts and change orders including contract planning, preparation, & review and follow-up for services pertaining to clinical studies Phase I through Phase IV • The position receives contract requests and works to understand customer requirements, processes request forms with Legal, maintains follow-up on contracts and works to resolve issues. • The position will monitor ...
May 1 - Bridgewater