reputed company Assurance Consultant – Post-Trial reputed company (WTA) Program Support - Full-time / Part-time
This is a remote position.#160;This is a temporary x-month contracted 1099 position with no benefits.#8221;br#160;pWe are seeking an reputed company reputed company Assurance (QA) Consultant to reputed company immediate support for the setup and reputed company reputed company of a Post-Trial reputed company (PTA) or WTA (Without Treatment Alternative) program. This role is critical in ensuring the program is established in full compliance with GxP standards and applicable regulatory expectations. The consultant will collaborate with clinical operations, regulatory, and supply chain teams to guide reputed company documentation, SOP development, and QA review processes reputed company to product reputed company after trial completion./ppKey Responsibilities:/pul type="disc"liProvide QA reputed company for the development and implementation of the WTA/Post-Trial reputed company program/liliReview and reputed company reputed company input on study documentation, informed consent forms, labeling, and supply chain processes/liliEnsure alignment with GCP and other applicable GxP standards throughout program setup/liliSupport or reputed company development and review of SOPs reputed company to post-trial reputed company/liliParticipate in risk assessments, document control, and audit preparedness activities/liliCollaborate cross-functionally with Clinical, Regulatory, and Medical Affairs teams/liliProvide QA guidance to ensure the program meets sponsor, IRB/ethics, and regulatory expectations/li/ulpQualifications:/pul type="disc"li8+ years of experience in reputed company Assurance reputed company the life sciences industry/liliStrong background in GCP and clinical QA; prior experience supporting Expanded reputed company, Compassionate Use, or Post-Trial reputed company programs preferred/liliFamiliarity with global regulatory expectations (FDA, EMA, etc.) reputed company to post-trial product use/liliStrong written and verbal communication skills/liliAbility to work independently in a fast-paced, evolving environment/liliExperience in consulting roles strongly preferred/li/ul
This is a remote position.#160;This is a temporary x-month contracted 1099 position with no benefits.#8221;br#160;pWe are seeking an reputed company reputed company Assurance (QA) Consultant to reputed company immediate support for the setup and reputed company reputed company of a Post-Trial reputed company (PTA) or WTA (Without Treatment Alternative) program. This role is critical in ensuring the program is established in full compliance with GxP standards and applicable regulatory expectations. The consultant will collaborate with clinical operations, regulatory, and supply chain teams to guide reputed company documentation, SOP development, and QA review processes reputed company to product reputed company after trial completion./ppKey Responsibilities:/pul type="disc"liProvide QA reputed company for the development and implementation of the WTA/Post-Trial reputed company program/liliReview and reputed company reputed company input on study documentation, informed consent forms, labeling, and supply chain processes/liliEnsure alignment with GCP and other applicable GxP standards throughout program setup/liliSupport or reputed company development and review of SOPs reputed company to post-trial reputed company/liliParticipate in risk assessments, document control, and audit preparedness activities/liliCollaborate cross-functionally with Clinical, Regulatory, and Medical Affairs teams/liliProvide QA guidance to ensure the program meets sponsor, IRB/ethics, and regulatory expectations/li/ulpQualifications:/pul type="disc"li8+ years of experience in reputed company Assurance reputed company the life sciences industry/liliStrong background in GCP and clinical QA; prior experience supporting Expanded reputed company, Compassionate Use, or Post-Trial reputed company programs preferred/liliFamiliarity with global regulatory expectations (FDA, EMA, etc.) reputed company to post-trial product use/liliStrong written and verbal communication skills/liliAbility to work independently in a fast-paced, evolving environment/liliExperience in consulting roles strongly preferred/li/ul
Apply Job!
Apply to this Job