- Merck & Co. (Durham, NC)
- …project management concepts and techniques as they relate to laboratory testing start - up , regulatory requirements for method transfer/validation project ... support cGMP and regulatory compliance during facility design, construction, start - up method transfer/validation activities and routine product testing to… more
- Merck & Co. (Rahway, NJ)
- …and personnel decisions standpointExperience in equipment Fabrication, FAT/SAT, start - up , qualification and/or validation is preferredFill/finish process ... to support formulation and process development and document technical reports and regulatory filings. The successful candidate will be key in implementing strategy,… more
- Novo Nordisk Inc. (Boulder, CO)
- …equipment, instrumentation, and materials of construction to design, specify, procure, start - up , fully commission and troubleshoot equipment and systems Ability ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of the engineering and verification program Technically independent and maintains up -to-date knowledge of industry standards and regulatory compliance ... the development of best practices Coordinate fabrication, procurement, installation, engineering start - up , and validation activities of new equipment and systems… more
- Merck & Co. (Durham, NC)
- Job DescriptionThis role is within a capital project start - up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, ... but are not limited to:Project SupportSupports project team as operations expert through start - up , commissioning, qualification through licensure and ramp up … more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …salary support, but opportunities for research collaborations and trainees. Competitive start - up package and long-term institutional support to include ... utilize prior academic experience to optimize resource allocation, ensure regulatory compliance, and uphold rigorous scientific standards. Understanding best… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Serve as the subject matter expert for Study Data Managers during the planning/ start - up , conduct and close-out of external data management activities by managing ... for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically… more
- Tris Pharma (Monmouth Junction, NJ)
- …sales leadership experiencePrior experience leading brands Experience working in a start - up pharmaceutical environment Travel requirements20 - 25% including ... and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, oversees implementation, and monitors...NJ; Must be willing to work at our offices up to 4 days per weekTris Pharma, Inc. offers… more
- Merck & Co. (Rahway, NJ)
- …Manager on study deliverables.Participates in the set up and design during study start up (eg, database set up )Lead medical monitoring team in review ... activities on clinical protocols.Apply strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Manage multiple competing priorities with… more
- Merck & Co. (Durham, NC)
- …raw materials, intermediates, and finished products.This role is within a capital project start - up in Durham, North Carolina. The new facility will include ... not limited to; Project Support Supports project team as operations expert through start - up , commissioning, qualification through licensure and ramp up of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working on shift as necessary to support operational needs.Experience with start - up of new pharmaceutical manufacturing facilities preferred.Experience with ... processes to be qualified/validated based on corporate/site guidelines, procedures, regulatory guidelines, and industry practicesStrongly interface with Operations Department… more
- Eisai, Inc (Nutley, NJ)
- …Trial Assistant will support all phases of clinical study activities (feasibility, start - up , conduct and close-out) under the direction and supervision by ... Ensures study is conducted within clinical trial protocols. Monitors progress and follows up with team members and line managers when issues develop. Implements and… more
- Merck & Co. (Durham, NC)
- …may include but are not limited to;Support operations production through start - up and commissioning and qualification through licensure and ramp ... up .Working in conjunction with all appropriate personnel, performs manual...hands-on training.Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements.Demonstrated ability to work both independently and as… more
- ICON Clinical Research (Brentwood, TN)
- …(CDP) to the Central CDP Review Team (CDPRT) and Sponsor. **What you need for Study Start Up Associate I - Regulatory Submissions** * A high school diploma ... Review Board (IRB) Submissions + Collect, review, organize and assemble regulatory initial start - up and maintenance submission packages to Central EC/IRB,… more
- IQVIA (Durham, NC)
- …Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start - up and maintenance phase as an integral member of the ... manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award… more
- University of Pennsylvania (Philadelphia, PA)
- …of the initiation of Phase I-V clinical trials with a focus on required regulatory start - up approvals and associated site initiation documentation. Reporting ... The CRU OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs Start - Up Specialist-CC to facilitate, with minimal supervision, the … more
- Houston Methodist (Houston, TX)
- …also work with industry sponsors' or grant funder's regulatory personnel for study regulatory start up and study regulatory maintenance throughout ... At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading,...is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions or external… more
- Actalent (Orlando, FL)
- …Quality assurance + Regulatory documents + Regulatory compliance + Regulatory submission + Start - up , maintenance, and close-out of studies Additional ... Research Regulatory Specialist III Job Description The Research Regulatory Specialist III provides regulatory support to the research team by conducting all… more
- University of Miami (Miami, FL)
- … Analyst II reviews, prepares, and provides oversight for initial and subsequent regulatory submissions from study start - up through study closure as ... well as the maintenance of regulatory documents to ensure compliance with applicable requirements and...the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for… more
- University of Washington (Seattle, WA)
- …institutional regulations. This position will be responsible for expeditious coordination of the regulatory submissions in the study start - up phase to meet ... studies. This individual will be responsible for overseeing the regulatory coordination of up to 30 active...outside of the research team. * Assist in study start up activities. * Assist in writing… more
