Search Results: 49 vacancies
...or CMO
Drafting documents for quality support on investigations, OOS, and OOTs
Contributing to regulatory documents, including CTA or IND, to advance drug development
Handling complex shipping of GMP materials from CMO to CROs
Overseeing and troubleshooting...
Suggested
Local area
Remote job
2 days per week
...preferred.
* Demonstrated experience in authoring and preparing IND submissions.
* Experience as primary regulatory author for IND and CTA documents
* Strong knowledge of US and EU regulations and guidelines pertaining to the conduct of investigational drug studies;...
Suggested
Shift work
3 days per week
...teams on the content, format, style and architecture of an Investigational New Drug (IND) application, Clinical Trials Application (CTA), Investigational Medicinal Product Dossier (IMPD) and New Drug Application (NDA). Writes and/or reviews submission sections and evaluates...
Suggested
Remote job
Contract work
Local area
Night shift
...other regulations.
* Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval.
* Support drug registrations (...
Suggested
...preparing Clinical Pharmacology portions of regulatory documents such as the pre-IND, IND, IB, briefing documents, clinical study reports, CTA, and BLA submission documents.
* Previous experience in antibody-drug conjugates and/or oligonucleotides is desirable.
* Ability...
Suggested
Relief
Local area
Remote job
...Key Skills:
Well-versed in regulatory strategy, and regulatory writing
Experience as primary regulatory author for IND and CTA documents; experience with EU CTR would be beneficial.
Knowledgeable in ICH, FDA and EMA guidelines
Knowledge of eCTD...
Suggested
Local area
Remote job
...interactions with global regulatory authorities, including authoring briefing documents, attending in person meetings, and contributing to IND, CTA, IDE, expedited pathway, 510(k), PMA, NDA, and/or MAA filings
* Be the accountable study responsible physician for Phase 1-3 oncology...
Suggested
...to meet PS , R&D and Takeda objectives .
Provides GMP and GLP reliable testing methods and analytical testing data for IND/CTA to NDA/MAA submissions in countries across the world that will serve as the basis for marketing approval.
Develops and implement...
Suggested
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
Night shift
...PREFERREDexperience in both CT and X-Ray are expected to operate both CT and X-Ray equipment. CT technologist should be proficient in CT, CT CTA imaging, Post Processing, IV contrast administration and contraindicators. Previous experience operating a Philips CT unit 64 slice...
Suggested
Immediate start
Shift work
...Accountable for the management and delivery of all CMC regulatory milestones, including global investigational drug filings (e.g., IND / CTA / IMPD / GMO), registrational filings (e.g., BLA, NDS, MAA, and supplements), and responses to health authority questions/requests....
Suggested
Flexible hours
...Proven experience working with the FDA leading major Regulatory submissions for oncology indications; having led successful BLA and CTA fillings is preferred.
~ Demonstrated deep understanding of the US Regulatory frameworks is essential.
~ Ability to effectively liaise...
Suggested
Summer work
Local area
Work alone
Flexible hours
...excel in the role of Full Time Senior Vice President, Regulatory Affairs and Quality at Beacon Therapeutics, proficiency in IND and CTA regulatory processes, as well as a deep understanding of the regulatory frameworks in the US and EU, is essential. Familiarity with Gene...
Suggested
Full time
Remote job
Work from home
Flexible hours
...demonstrates proficient and current knowledge in Computed Tomography practice including patient positioning post-processing for routine exams (CTA Head and Neck), ALARA principles.
2. Performs and documents patient assessment/history related to procedures verifies correct...
Suggested
Work experience placement
Local area
...administrative and operational support provided to the clinical trial teams.
What You’ll Do:
Develop, mentor, manage and coach CTA staff to progress their skills so that Deciphera’s quality standards are met
Ensure CTA personnel work to the highest quality standards...
Suggested
Temporary work
Summer work
Summer holiday
Flexible hours
...Technology, or related field. Master's degree preferred.
Salesforce certifications such as Salesforce Certified Technical Architect (CTA), Salesforce Certified Application Architect, and Salesforce Certified System Architect are highly desirable.
Minimum of 10 years...
Suggested
Remote job
Work experience placement
...stability program. Conduct trend analysis with relevant software for all compounds in the portfolio
* Author and review IND/IMPD and NDA/CTA submissions
* Generate batch genealogy for clinical and commercial materials
Physical Requirements
Up to 15% travel to...
Contract work
Local area
...the creation of document packages for regulatory submissions and management of document package preparation, inclusive of new INDs, CTA, NDA/BLAs, MAA, variations.
Assist in the preparation for meetings with global health authorities, inclusive of support for briefing...
Local area
...aimed at conquering cardiovascular disease. Our Image Processing Engineers develop and test tissue characterization algorithms from CT, CTA, Spectral CT and MRI modality images. In addition, they will analyze data and develop methods using machine learning for feature...
Work experience placement
Remote job
...of Global Programs and
Partnerships.
Supports the development of and facilitates the management of Credit Transfer Agreement (CTA) relationships in support of Global Programs and Partnerships and Academic Affairs goals
and objectives.
Serves as a member of...
Full time
Contract work
Temporary work
Local area
...biomarker assays, supporting their implementation on clinical trials
~ Experience delivering data and documentation supporting IND/CTA regulatory filing
~ Scientific experience working in the cardiovascular, renal therapeutic areas are highly desirable for this position...
Immediate start
Flexible hours
