Clinical Regulatory BA - Pharma/Biotech, ALM Vera Expert
TechDigital Group
An established industry player is seeking a Business Analyst with a strong clinical regulatory background to join their team. This role requires a minimum of five years of experience in the Pharmaceutical or Biotech industry, along with a deep understanding of clinical research processes. The ideal candidate will manage relationships with SaaS vendors and internal business groups, leveraging tools such as ServiceNow and ALM VERA to streamline operations. This is an exciting opportunity to contribute to impactful projects in a dynamic environment where your expertise will drive innovation and compliance in clinical regulatory affairs. #J-18808-Ljbffr TechDigital Group
$70k - $110k
Role Summary The Clinical Research Associate (CRA) is primarily responsible for ensuring... ...with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.... ...passionate about working clinical research and biotech, and we welcome people who identify as...RegulatoryContract workLocal areaRemote workFlexible hours- Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with... ...team of passionate industry experts who are leading, shaping,... ...the protocol and applicable regulatory regulations. The CTM also... ...operations role in biotech, pharmaceutical, academic...RegulatoryInterim roleWork at office
- An established industry player is seeking a seasoned Business Analyst with a strong clinical regulatory background. With over 10 years of experience in the Pharmaceutical and Biotech sectors, you will play a crucial role in enhancing clinical development processes and...Regulatory
- Mandatory Skills - Business Analyst with Clinical Regulatory Background Minimum 10+ years of experience in Pharmaceutical/Biotech industry - Clinical Development processes, program... ...Tools/Technologies: simulation tools, SSO; ALM VERA; Veeva Vault, eTMF, Snowflake, Power BI, MS...Regulatory
$93.1k - $232.8k
...IQVIA Biotech is seeking a Sr. Clinical Project Manager with experience in the following therapeutics: Cardiovascular, Renal, and Metabolic. IQVIA... ...studies in alignment with contractual requirements, SOPs, and regulatory standards. Develop and implement integrated study...RegulatoryFull timePart timeImmediate start$71.9k - $169.3k
...CRA 2 Opportunity at IQVIA Biotech IQVIA Biotech is now hiring for CRA 2 with a minimum... ...Overview: We are seeking a dedicated Clinical Research Associate (CRA) to join our team... ...ensure compliance with study protocols, regulatory requirements, and sponsor expectations....RegulatoryFull timePart timeImmediate startWorldwide$93.1k - $232.8k
Job Overview IQVIA is hiring a clinical project manager to expand our dedicated Real World... ...within the environment of a prominent pharma company. In this role, the clinical project... ...applying applicable clinical research regulatory requirements Experience with primary and...RegulatoryFull timePart time$93.1k - $232.8k
IQVIA Biotech is a full‑service CRO purpose‑built to serve biotech sponsors. With over 2... ...treatments to patients faster. US‑based Clinical Project Manager with proven experience... ...with contractual requirements, SOPs, and regulatory standards. This role blends strategic leadership...RegulatoryFull timePart timeLocal areaImmediate start- ...Description: BASIC SUMMARY: Subject matter expert for the company’s statistical services... ...setting strategy for complex protocols, regulatory submissions, or development programs.... ...based projects such as NDA submissions, clinical development programs, or complex, multi-...RegulatoryWork experience placementWork at office
- Aerogen Pharma, located in Morrisville, NC, is seeking a Clinical Trial Manager to oversee various aspects of clinical trials, including site management and vendor... ...clinical operations and a strong understanding of regulatory requirements. The ideal candidate will demonstrate...Regulatory
- ...future focused approaches to clinical trials with a focus on patient... ...on the Company's pool of experts. Drive communication and collaboration... ...standards, SOPs, client, and regulatory requirements. Partner with... ...experience within a CRO or pharma. Strong ophthalmology...RegulatoryContract workWork at officeLocal areaRemote workFlexible hoursNight shift
- ## Associate Clinical Safety Surveillance DirectorApplyremote type:... ...are the first publicly-traded biotech or pharmaceutical company to... ...readiness posture, and sustained regulatory compliance across the UT... ...serving and being recognized as an expert within organization, both...RegulatoryWork at officeLocal area3 days per week
$93.1k - $232.8k
IQVIA Biotech is a full‑service CRO purpose‑built to serve biotech sponsors. With over 2... ...treatments to patients faster. Drive global clinical trials from first site activation to... ...teams, and ensure compliance with ICH‑GCP, regulatory requirements, and study protocols . This...RegulatoryFull timeContract workPart timeWork at officeImmediate startWorldwide- GlaxoSmithKline is seeking a Principal Medical Writer in Durham, NC to lead medical writing for complex clinical and regulatory projects. The ideal candidate will have 5+ years of experience in the pharmaceutical industry and a Bachelor's degree in life sciences. This role...Regulatory
$59.83k - $99.96k
...Duke PF is seeking a Clinical Research Coordinator for the Duke Cancer Institute in Durham, NC. In this hybrid position, you'll manage study operations, recruit participants, ensure regulatory compliance, and act as a liaison among stakeholders. Qualifications include...Regulatory$220k - $245k
Fortrea in Durham is seeking an executive leader for Quality Assurance and Regulatory Compliance in the Clinical Pharmacology Services business unit. This role requires 15+ years of experience and expertise in GCP and GMP, with a focus on clinical pharmacology. The successful...Regulatory- ...relevant, and ready to support clinical studies, payer/HTA... ...strategy for the use of RWE in regulatory, payer, and HTA contexts, serving... ...in HEOR/RWE within pharma, biotech, or medical devices Deep knowledge... ...internal stakeholders and external experts/KOLs Excellent...RegulatoryFull timeContract workWork at office
$93.1k - $232.8k
...while assuring compliance to all applicable regulatory requirements. Responsible for the... ...companion diagnostics studies sponsored by Pharma partners. Ensuring adherence to regulations... ..., including CROs. Collaborating across Clinical Operations and other functions to...RegulatoryFull timeTemporary workPart timeImmediate startWorldwide$28.6 - $44 per hour
Join to apply for the Oncology Clinical Data Manager role at Labcorp... ...providers but help medical, biotech, and pharmaceutical companies... ...compliance with legal, ethical, and regulatory standards. Provide strategic... ...knowledge in a new way. Experts add insights directly into...RegulatoryFull timePart timeCasual workReliefWork at officeFlexible hours- Bioventus LLC. is seeking a Senior Regulatory Affairs Specialist in Durham, NC to provide regulatory support for product approvals and renewals... ...with various regulations, and serving as the Subject Matter Expert during audits. The ideal candidate should have a Bachelor’s...Regulatory
- ...system. You will review and monitor medication therapy, dispense medications, and educate care teams and patients while ensuring regulatory compliance. Your role includes advising physicians on drug usage, contributing to education programs, and overseeing drug information...Regulatory
- GRAIL in Durham, NC, is hiring a Clinical Laboratory Technologist to perform laboratory tests that support clinical studies and maintain... ...have a Bachelor's degree in a life science and knowledge of regulatory compliance in laboratory settings. This full-time role...RegulatoryFull time
- ...North Carolina. The role includes managing site communications, maintaining documentation, and ensuring compliance with regulatory standards in clinical research. Candidates should have a college degree and a minimum of 2 years' experience in the clinical research field....RegulatoryWork at office
$57 - $71.32 per hour
...Description Job Title: Contract Clinical Study Manager Job... ...ICH/GCP guidelines, applicable regulatory requirements, company SOPs, study... ...and engage with the broader biotech ecosystem of the Research Triangle... ...access to specialized experts who drive scale, innovation and...RegulatoryContract workTemporary workWork at officeRemote workMonday to FridayDay shift3 days per week- RIT Solutions in Durham, NC, seeks an experienced operations leader to oversee assigned clinical studies, ensuring compliance with ICH/GCP, regulatory requirements, and company SOPs. The role provides onsite leadership remotely supporting study start-up through close-out...RegulatoryRemote job
- ...Clinical Research Coordinator Location: Chapel Hill, NC 27516 (... ...as mentor and subject matter expert. The BTN Coordinator will independently... ...of research protocols and regulatory correspondence, and... ...subject has been identified and make decisions. Global Pharma TekRegulatoryWork at officeWeekend work
- The Clinical Laboratory Supervisor is responsible for overseeing the day-to-day testing activities in the Diagnostic Services' CLIA... ...diagnostic testing, and maintaining rigorous compliance with regulatory and quality standards. The Supervisor will play a pivotal role...RegulatoryTemporary workWorldwideShift work
$73.7k - $117.92k
.../providers to ensure compliance with departmental, plans, and regulatory policies and procedures. Assist in designing effective learning... .... Act as a day‑to‑day resource for technical assistance and clinical decision making. Provide guidance with interpretation of clinical...RegulatoryWork experience placementWork at officeLocal areaRemote workFlexible hours$56.99 - $71.32 per hour
...Clinical Study Manager Job Number: 366219 Category: Biologist Description: Job Title... ...with ICH/GCP guidelines, applicable regulatory requirements, company SOPs, study protocols... ...(yrs): 8 Required Education: Bachelor (BA, BS...) Benefits: Return to search results...RegulatoryContract workTemporary workWork at officeLocal areaImmediate startWorldwideShift work- ...departmental protocol, policies and procedures, and compliance with regulatory agencies, to include but not limited to pre‑admission,... ...referrals as required. Communicate with insurance carriers regarding clinical information requested and to resolve issues relating to...RegulatoryWork at officeLocal area
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