SUMMARY OF POSITION. The Associate, Regulatory Labeling prepares, reviews and submits to his / her manager high-quality regulatory labeling submissions intended for the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions will include ANDAs, amendments, supplements, Annual Reports and advertising and promotion campaigns. This position researches and, under the direction of the Legal Te...
SUMMARY OF POSITION. Independently authors, compiles, reviews, schedules, and submits high-quality regulatory submissions in adherence with technical document standards that are fully compliant with FDA and ICH requirements within company timelines. Plans, coordinates and writes, clear, concise and accurate, responses to inquiries from FDA resulting from their review of the submissions. Submissions will include: ANDAs, Amendments, Supplements, An...
Job Description. Job Description. Requirements. Lead and execute long-form copy development for one or more brand engagements across HCP & Consumer audiences in the pharmaceutical marketing sector know, like the back of your hand, all aspects of the brand and disease state, including trials, studies, and patient profiles. Build strong relationships with Creative, Medical, Account, and Client brand teams, such that each group identifies you as the...
Job Description. Job Description. We need a BA to help elicit requirements from the clinical and regulatory stakeholders for system configuration and deployment. IRT is currently being deployed. SAS and eTMF are both in discovery phases but will kick off in next 30-60 days. Requirements Gathering, Business Process & Writing Tasks. Experiencing supporting clinical and regulatory stakeholder thru requirements and implementation of Cloud Clinical ap...
We are seeking an experienced and dynamic Lifesciences Headhunter to join our team in Princeton, NJ. As a key member of our team, you will be responsible for identifying and attracting top talent in the life-sciences industry, helping our clients build high-performing teams and achieve their business goals. Key Responsibilities. Utilize innovative sourcing and recruitment strategies to identify and attract top life-sciences talent. Build strong r...
Job Description. Job Description. Minimum Requirements. |. Role Responsibilities. Expertise in extracting, manipulating, summarizing, analyzing, and presenting data using SAS procedures· Expertise in SAS/MACRO, SQL, and SAS/BASE procedures. Expertise/experience. in use of SAS/GRAPH and Statistical procedures· Highly experienced working in Clinical data and medical dictionaries· Knowledge of relational database principles· ...
