- GRAIL (Durham, NC)
- …plus. + Advanced scientific degree preferred. + Regulatory Affairs Certification ( RAC ) preferred. + Experience in pharmaceutical clinical, statistical, or regulatory ... settings-especially in oncology, immunology, or related fields-is a plus. **Knowledge, Skills, and Abilities** + Proven leadership and sound judgment with strong business partnering skills. + Demonstrated knowledge of US and international regulatory frameworks… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC certification a plus. **Skills** - Strong oral and written communication skills. - ... Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc. - Able to successfully interpret and apply regulatory intelligence to work output. - Ability to lead teams, prioritized work,… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …Master's degree in life sciences field (preferred over Bachelor's) + RAC certification (Regulatory Affairs Certification) + PMP certification (Project Management ... Professional) + Familiarity with Electrical and Electromagnetic Equipment, Machinery, Data and Cybersecurity, Board of Pharmacy, and Environmental requirements + Working knowledge of medical device stand-alone software, device interoperability and IEC 62304… more
- Truist (Raleigh, NC)
- …Manage and coordinate the resource approval process in coordination with finance and the RAC . 16. Partner across the teams to define and scope projects and complete ... RFPs to contractually execute on those program across Truist. 17. Partner across the leadership team to define and execute on the Data, Analytics, AI, Gen AI and Technology strategy for Truist. **QUALIFICATIONS** Required Qualifications: The requirements… more
- ThermoFisher Scientific (Greenville, NC)
- …industry preferred + Additional qualifications in medical writing (AMWA; EMWA; RAC ) advantageous. **Knowledge, Skills, Abilities** + Significant knowledge of global, ... regional, national and other document development guidelines + Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills + In-depth knowledge in one or more specialty areas such as preclinical,… more
- Teleflex (Morrisville, NC)
- …complete tasks through collaboration. * Proficiency in MS Office software programs * RAC certification is a plus. TRAVEL REQUIRED: 10% \#LI-LM1 _At Teleflex, we ... follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front._ _Teleflex Incorporated is an equal… more
- ThermoFisher Scientific (Greenville, NC)
- …projects is preferred. Additional qualifications in medical writing (AMWA; EMWA; RAC ) advantageous. In some cases, an equivalency, consisting of a combination ... of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. **Knowledge, Skills, and Abilities:** + Excellent data interpretation and medical writing skills,… more
- ASM Research, An Accenture Federal Services Company (Raleigh, NC)
- …the data architecture strategies. + Implement and manage backup and disaster recovery procedures for Informatica repositories and configurations. + Work closely with ... JMS, PowerExchange, S3, S3 Delta, or Amazon RedShift. + Experience managing Oracle RAC and Data Guard databases. + Knowledge of UNIX/Linux commands and shell… more
- Parexel (Raleigh, NC)
- …and 510(j)(3) reporting through nextGen portals is a plus * Ensure audit readiness and version control through meticulous documentation and system management ... in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred * RAC certification is a plus Given the client's location, preference will… more
- CaroMont Health (Gastonia, NC)
- …Composes a detailed summary of care and sends appeals to MCO, Medicare, or RAC for reversal of original determination. May serve on the Medical Record/ Utilization ... Review Committee, providing detailed logs of denial activity and appeal results. Maintains the Status Change Database. Performs retrospective clinical reviews/appeals as part of denial process. The UR Specialist will be cross trained to work for the Commercial… more