- Merck & Co. (Rahway, NJ)
- …submissions (global clinical and marketing applications such as IND, CTA, NDA , and MAA) and limited CMC post-approval-changes.Leverage industry and agency ... regulatory work (global clinical and marketing applications such as IND, CTA, NDA , and MAA) and limited CMC post-approval change support.-Minimum of (7) years… more
- AUROBINDO (Dayton, OH)
- …Literature Search on assigned Projects.Thorough understanding of the ANDA (and preferably NDA ) filing process in line with QbD elements in generic product ... developmentExperience working with projects from bench-top stage to large scale manufacture of submission batchesShould have a sound knowledge of pharmaceutics, pharmacokinetics and process scale-up Qualifications - Skills & Requirements3-5 years of Senior… more
- Insmed Incorporated (San Diego, CA)
- …developmentExperience with IND/CTA submissions and global registration applications (eg, NDA , NDS and MAA)Prior experience leading direct interactions with Health ... AuthoritiesPrior experience in regulatory leadership within gene therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical and project teams)Ability and experience in the development and execution… more
- ASRC Industrial Services (Oak Ridge, TN)
- NDA Analyst - Engineer - Oak Ridge, TN Summary **Title:** NDA Analyst - Engineer - Oak Ridge, TN **ID:** 2252 - RSI - 02 Description _ASRC Industrial and its ... **Position Summary** RSI is actively seeking a Nondestructive Assay ( NDA ) Professional to support the NDA Program...Nondestructive Assay ( NDA ) Professional to support the NDA Program for the UCOR Cleanup Projects at Heritage… more
- Cleveland Clinic (Cleveland, OH)
- …for the ideal future caregiver include: + High School Diploma/GED + Basic Life Support (BLS) Certification through the American Heart Association (AHA) within new ... hire period Preferred qualifications for the ideal future caregiver include: + State Tested Nursing Assistant (STNA) Certification + Previous nursing assistance experience + Customer service or healthcare experience Our caregivers continue to create the best… more
- Cleveland Clinic (Cleveland, OH)
- …for the ideal future caregiver include: + High School Diploma/GED + Basic Life Support (BLS) Certification through the American Heart Association (AHA) within new ... Join Cleveland Clinic and experience world-class healthcare at its best. Cleveland Clinic Lutheran Hospital is a proud Magnet Hospital awarded by the American Nurses Credentialing Center, the highest honor an organization can receive for professional nursing… more
- Cleveland Clinic (Cleveland, OH)
- …+ Assist with wide variety of patient care tasks and collaborates with members of health care team to promote the delivery of patient care. + Organizes patient care ... assignments to ensure timely delivery and completion of care on assigned patients. + Seeks assistance as necessary for difficult assignments or problem solving. + Documents the care provided in patient record. + Labels specimens properly. + Asks patient about… more
- Cleveland Clinic (Cleveland, OH)
- …+ Responsible for transporting visitors and patients via wheelchair, cart or bed. + Practices injury prevention. + Ensures safety of self and patient when ... The Nursing Department Assistant II (NDAII ) is responsible for providing for patients' activities of daily living; maintaining a safe and clean environment; maintaining established levels of supplies; maintaining proper equipment function; and transportation… more
- Boehringer Ingelheim (Ridgefield, CT)
- …will also gain experience coordinating and executing regulatory activities required of an NDA Holder for compliance to FDA requirements for US products in BIPI's ... the regulatory impact of CMC changes on the US NDA . Define CMC documents needed to support the change....for submission, construct in eCTD format, and file supplemental NDA (sNDA) submissions for CMC changes, including those of… more
- Atlas Sand Company, LLC (Austin, TX)
- …the strategy for drug and alcohol testing programs; ensures NDA /Confidentiality Agreement compliance; and builds reporting capabilities that equip stakeholders ... FCRA, wage and hour, state labor law). + Ensure execution and retention of NDA and Confidentiality Agreements as conditions of employment. + Own the strategy for… more
- Actalent (Lexington, MA)
- …of experience in medical writing. + Experience as a lead contributing author for NDA submissions. + Understanding of regulatory writing in the rare disease field. + ... Proven ability to author NDA submission documents under accelerated timelines. Additional Skills &...The role offers the exciting opportunity to work on NDA submissions within the rare disease space. Pay and… more
- Sumitomo Pharma (Harrisburg, PA)
- …in Oncology. In addition, the candidate must have recent Oncology NDA submission experience and submissions worldwide including HTA submissions. The individual ... all non-clinical and clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as… more
- City of New York (New York, NY)
- …low-income communities it designates as Neighborhood Development Areas (NDAs). The NDA Initiative fosters community-level engagement to ensure that services address ... of each community. DYCD is seeking a Deputy Director to help lead its NDA Initiative portfolio. Under the supervision of the Director, with wide latitude for… more
- System One (Florham Park, NJ)
- …Must have Module 5 expertise. + Must have regulatory strategy experience in IND/ NDA development, not just life cycle management. + Must have regulatory strategy ... experience in IND/ NDA development, not just life cycle management. Overview Support...in development (including 2 new IND applications and 1 NDA ) + Knowledge of and Compliance with FDA, EMEA,… more
- Merck (Rahway, NJ)
- …strategy and submissions (global clinical and marketing applications such as IND, CTA, NDA , and MAA) and limited CMC post-approval changes. + Leverage industry and ... pre-approval regulatory work (global clinical and marketing applications such as IND, CTA, NDA , and MAA) and limited CMC post-approval change support. + Minimum of… more
- Abbott (Alameda, CA)
- …insulin and drug solutions for diabetes management or past experience in submitting NDA / BLA submissions is preferred. The individual has department level influence ... is a plus. + Experience with either 510(k) applications, PMA supplements, NDA , BLA, US Device regulations, US Combination Device regulations, US Biologics… more
- Sanofi Group (Morristown, NJ)
- …as designated. Leads submission team or regulatory sub-team to ensure NDA /BLA/MAA/Extensions filings meet the project timelines for product launch and is ... CMC not directly applicable. + Demonstrated experience with preparation of (s)BLA/(s) NDA /MAA, INDs/CTAs, HA meeting briefing documents and negotiating with a… more
- Bausch + Lomb (Juneau, AK)
- …labeling, adpromo domains + Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC products and dietary supplements + Plan, ... as PAS, group supplements, site transfers, and supplier changes) for IND, NDA , ANDA amendments/supplements + Review raw materials and formulations, provide advice to… more
- Bausch + Lomb (Juneau, AK)
- …development and acquisitions. + Lead all CMC regulatory activities for IND, NDA , ANDA, and BLA submissions. + Plan, author, review, and coordinate high-quality ... as PAS, group supplements, site transfers, and supplier changes) for IND, NDA , ANDAs and amendments/supplements. + Serve as RA representative on facility/site Local… more
- Taiho Oncology (Princeton, NJ)
- …study protocols and clinical study reports (CSRs), investigator brochures, DSUR, NDA /MAA registration documents and publications. + Reviews and summarizes ongoing ... and final clinical study data, protocols and CSRs, investigator brochures, DSUR, NDA /MAA registration documents and publications. + Ability to critically review and… more
