- ThermoFisher Scientific (Wilmington, NC)
- …timelines and budget, and in alignment with applicable SOPs and regulatory requirements. Successful candidates have extensive experience driving global clinical ... all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. + Ensures that essential document… more
- Sumitomo Pharma (Raleigh, NC)
- …using SAS + Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc. + Executing Pinnacle ... 21 Checks + Knowledge about CDISC and Regulatory Guidelines + Demonstrate coaching skill to mentor Statistical...to achieve objectives in innovative and efficient ways. + FDA submission experience is a must. + Solid knowledge… more
- ThermoFisher Scientific (Greenville, NC)
- …and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) ... attention to detail + In-depth understanding of relevant regulations eg ICH/GCP, FDA guidelines, etc. + Strong computer skills to effectively use automated systems… more
- Pfizer (Rocky Mount, NC)
- …Procedures (SOPs) and/or Batch Records and shall maintain compliance with all relevant regulatory body and license requirements (ie, FDA , USP, etc.). Accurate ... public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses… more
- Teleflex (Morrisville, NC)
- …representative during acquisitions, collaborating with teams in Quality Assurance, Regulatory Affairs, Supply Chain, Design, and Manufacturing. Additionally, it ... supplier quality in cross-functional projects to meet company and regulatory goals. **Principal Responsibilities** * Coordinate with Global Procurement, Site… more
- American Airlines (Charlotte, NC)
- …Coordinator is responsible for investigating irregularities and interfacing with both regulatory agencies and internal subject matter experts. Areas of oversight may ... + Hazardous waste storage and handling procedures + FAA, TSA, DOT, and FDA regulations + Environmental, Safety, Security, and OSHA regulations + Compliance for… more
- UNC Health Care (Raleigh, NC)
- …trials, conducts all patient follow-up requirements, maintains clinical trial regulatory documents. Current trials include cardiac stents and devices, carotid ... phone and/or web teleconferences for currently enrolling studies. 7. Maintain regulatory documents for currently enrolling studies. Print and file all sponsor… more
- United Therapeutics (Raleigh, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... in PAH/ILD therapeutic areas + Current working knowledge of local legal, regulatory , and compliance regulations and guidelines relevant to industry interactions with… more
- Parexel (Raleigh, NC)
- …+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Must be fluent in English and in ... command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical… more
- Merck (Wilson, NC)
- …Conforms to established safety procedures in accordance with OSHA and other regulatory agencies. Recognizes, utilize, and encourage others to use safety equipment ... or equivalent **Required:** Minimum of three (3) years' experience in a FDA regulated industry. Must have excellent verbal and written communication skills. Must… more