> Personnel
Services
> For Employers
> For Job Seekers
> Getting Started
> Why Choose Us
> Our Clients
> Testimonials
> News
> About Us
> Locations & Directions
> Contact
In this role you will monitor raw materials, pre-clinical toxicology and clinical safety study design. In assition you will prepare safety documentation fir IND and NDA filings. This is a high visibility career making opportunity for the right person. You will represent your division on cross functional teams and participate i new product development. Principal Scientist Microbiology This opportunity is in the South. This is a role for a leader in microbiological testing for non-sterile pharmaceutical products. Our client has a unique opportunity for an experienced microbiologist with in-depth technical knowledge of FDA regulations, GMP and pharmaceutical product manufacturing processes. Manager, Regulatory Affairs Position Description: Responsible for the coordination, compilation, submission and maintenance of INDs, DMFs, NDAs, and BLAs to the FDA, and other global regulatory authorities as requested. Manages the submission of INDs, DMFs, NDAs, BLAs, progress reports, supplements, amendments and experience reports. Reviews, evaluates, and compiles files and reports for submission. Ensures that pre-clinical strategies and clinical trial protocols are properly designed to comply with regulatory guidelines. Facilitates the rapid and timely approval of new drugs. Interacts with regulatory agency personnel in order to expedite approval of pending applications and resolution of on-going agency/company issues. Coordinates and maintains reporting schedules for applications. Maintains current knowledge of regulatory standards. Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure adequate and complete submissions. Works directly with clinical development, project management, and quality assurance functions to create systems that assure integrity and quality of submissions. Works with Research and Development during new-product start-ups and product development. Contributes to the establishment of regulatory strategies for new products and processes. Participates in management level departmental development initiatives. Experience: 5 years experience in pharmaceutical regulatory affairs to include NDAs, INDs, BLAs, biologics, drugs, oral solid dose, parenterals, CMC, clinical and pre-clinical requirements. Global regulatory experience, advanced degree, and RAP certification are a plus. Position Requirements: Education: Minimum of a Bachelor’s degree in a scientific discipline Technical Skills: Computer literacy necessary, preferably in MS Office applications such as Word, Excel, Access and PowerPoint Non-Technical Skills: Excellent oral and written communication skills needed. Ability to multi-task essential. Position requires 10-15% travel. Contact Pat at 732-431-2600 or email pat@snellingnj.com Drug Safety Surveillance Position Description: Responsible for the processing of SAE reports, including entry of SAE/AE information into Argus Safety, writing medical narratives, and communicating SAE/AE report information both internally and externally. Responsible for requesting, tracking and processing follow-up information. Responsibilities include: Process SAE/AE cases in a manner which produces prompt, accurate, quality cases; Provide SAE/AE source documents electronically; Triage reports to ensure timely processing of all reports; Code medical terms using the MedDRA dictionary; Prepare medically-accurate narratives; Conduct follow-up querying with the reporter to capture additional relevant data; Communicate with medical directors to discuss the need for additional information or necessary changes to SAE/AE cases; Prepare and deliver expedited reports to those responsible for distribution; Provide support for SAE reconciliation with the clinical database to achieve database lock for each clinical study; Provide SAE narratives for each CSR in accordance with the project plan schedule; Draft and maintain MedDRA coding conventions, Argus Safety Data Entry conventions, and related Argus Safety procedures; Provide Argus Safety data entry training to all Argus users; Create a database for submitted regulatory reports that will be used by clinical personnel to update sites initiated after a new version of the IB is issued; Provide Annual IND Report information in accordance with the project plan schedule and in compliance with US regulations. Experience: Minimum of two years of experience in processing adverse events. Detailed knowledge of all AE processing functions, e.g., product label/reaction assessment, medical coding, and narrative writing. Basic knowledge of US and international regulations surrounding the processing and reporting of adverse events. Position Requirements: Education: B.A./B.S. or RN, BSN, Pharmacy Degree Technical Skills: Knowledge of a computerized Safety database and MedDRA. Knowledge of Microsoft Office. Demonstrated ability to learn new software applications. Non-Technical Skills: Strong written and verbal communication skills, team attitude and process management skills. Contact Pat at 732-431-2600 or email pat@snellingnj.com Manager, Medical Writing Position Description: Manages medical writing projects and prepares high-quality documents (ie, clinical study reports, protocols, and components of global regulatory submissions) in compliance with regulations. Participates as a member of clinical and medical writing teams and works in collaboration with multidisciplinary project teams to ensure that all documentation is accurate and complete. Prepares, edits and reviews clinical documents with guidance from Clinical Research, Biostatistics, Regulatory Affairs and Drug Safety; Prepares templates, clinical study documents, and components for IND/NDA/CTD submissions according to regulatory authority requirements and local regulations; Assists in the preparation of manuscripts, abstracts, posters, and reviews articles, as needed; Leads the documentation process and ensures compliance with FDA/ICH guidance documents; Reviews and edits documents for organization, clarity, use of English language/grammar, consistency, and scientific standards; Resolves errors and inconsistencies in clinical data with Biostatistician and other project team members; Provides guidance to Clinical Research, Biostatistics, and other functions. Experience: This position requires a minimum of 5 years in regulatory medical writing for a pharmaceutical, biotechnology or contract research company/university medical center, and an understanding of clinical regulatory documentation requirements. Experience as lead-writer for key documents in major US and international regulatory submissions is highly desirable. Position Requirements: This position requires a Bachelor’s degree in science or an appropriate discipline; Master’s degree preferred. Technical Skills: Must demonstrate a clear, high quality scientific writing style in the English language, and have the ability to independently analyze and synthesize data from a broad range of disciplines. Must be proficient with Microsoft Office applications. Non-Technical Skills: Must be organized, have the ability to successfully manage multiple projects from conception to completion, be able to work in a fast-paced team environment, and have excellent verbal communication skills. Contact Pat at 732-431-2600 or email pat@snellingnj.com Manager of Regulatory Affairs Position Description: The Manager of Regulatory Affairs will be responsible for managing and assisting in the coordination, review, compilation, assembly, filing and tracking of applications through the FDA review process to ensure rapid review and approval. This position has an excellent potential to be promoted to a director of regulatory. Developing and implementing regulatory strategies to expedite the development, filing and regulatory approval of new products, as well as the protection and continued marketing of existing products. Representing regulatory concerns on assigned project teams. Supplying appropriate advice to ensure compliance with all regulatory requirements. Compiling, assembly, and filing documentation for products to regulatory authorities and assuring that all submissions are presented in a manner to facilitate review and conform with appropriate regulations and guidelines. Tracking submissions and initiating internal communications to adequately respond to agency inquiries and requests. Creating RFPs (request for proposals) for external vendors and coordinating activities of Contract Research Organizations Identifying and establishing contracts with trial sites. Location: Rockville, Maryland. Requirements: The successful candidate must have a strong knowledge of the drug development process, GMPs, regulations and guidelines including labeling, advertising, and IND/NDA filing. Minimum of three years of pharmaceutical regulatory affairs experience is required. Good oral and written communication and negotiation skills are required. This position requires a Bachelors degree or higher. PharmD or MPH is preferred. Contact Pat at 732-431-2600 or email pat@snellingnj.com |
Home ~ Personnel
Services ~ For Employers
~ For Job Seekers
~ Getting Started ~ Why
Choose Us ~ Our Clients
Testimonials ~ News
~ About Us ~ Locations
& Directions ~ Contact ~
Site Map ~ Staffing
Resources
© 2004, Snelling Personnel Services. All rights reserved.