$124800 USD - $208k USD / hour
... detailed grading rubrics and technical documentation. Preferred Experience - Experience preparing submission-ready deliverables for regulatory agencies such as the FDA or EMA . Compensation & Engagement This is a remote contractor opportunity with output-based compensation. Experts are paid per task that meets project specifications. ...
$124800 USD - $208k USD / hour
... detailed grading rubrics and technical documentation. Preferred Experience - Experience preparing submission-ready deliverables for regulatory agencies such as the FDA or EMA . Compensation & Engagement This is a remote contractor opportunity with output-based compensation. Experts are paid per task that meets project specifications. ...
$124800 USD - $208k USD / hour
... detailed grading rubrics and technical documentation. Preferred Experience - Experience preparing submission-ready deliverables for regulatory agencies such as the FDA or EMA . Compensation & Engagement This is a remote contractor opportunity with output-based compensation. Experts are paid per task that meets project specifications. ...
675k
... meetings, investigator meetings, training, client meetings and bid defenses). Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take ...
$30 USD
... traceability matrices. - Strong knowledge of defect management, test evidence, and validation documentation controls. - Familiarity with regulatory expectations such as FDA 21 CFR Part 11, EU Annex 11, and data integrity principles. - Experience using test management and defect-tracking tools such as ALM, Jira, Azure DevOps, or similar ...
India, Bengaluru
View vacancy... Experience in medical device design & development in Agile environment is a plus. Understanding of software development processes for a regulated environment (FDA/ISO13485) and experience in medical device verification is a plus Whether it's a health care program or paid time off, our programs contribute to life beyond ...
India, Bengaluru
View vacancy... documentation, including protocols, reports, and standard operating procedures (SOPs). - Ensure all CQV activities comply with relevant regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ISPE, ASTM). - Coordinate with cross-functional teams to ensure seamless project execution. - Provide regular project updates ...
India, Gurugram
View vacancy... successful experience in all relevant clinical data management activities in a Pharmaceutical or CRO setting. - Working knowledge of clinical trial research, including FDA, GCP/ICH guidelines, GDPR, CDISC/SDTM standards and 21 CFR Part 11 - Proficient in Microsoft Word and Excel. - Excellent written and oral communication skills. ...
India, Itanagar
View vacancy... Biology, Chemistry - 4 years of related experience in a life science GxP environment with CRO experience preferred - Hands-on experience with ~ ICH-GCP (E6 R2/R3) - FDA regulations (e.g., 21 CFR Part 11) - EMA / EU CTR / Annex 11 - GxP frameworks (GCP, GMP, GLP, GCLP) Preferred Certification ASQ Certified Quality Auditor (CQA) ...
India, Bengaluru
View vacancy... execution of validation plans, URSs/DQ/TMs/FATs/SATs/IQ/OQ protocols/reports. - Ensure all CQV activities comply with relevant regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ISPE, ASTM) and meets data integrity (ALOCOA+) principles. Well versed in commissioning and qualifying CIP & SIP systems Here's ...
India, Gurugram
View vacancy80k
... proofreading skills, and the ability to communicate scientific concepts to diverse audiences. - Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review ...
India, Bengaluru
View vacancy... level for at least one Project. Technical Skills: - Experience with paperless validation software such as KNEAT and/ or Valgenesis. - In-depth knowledge of cGMP, FDA, EMA, and other relevant regulatory requirements. - Strong project management skills with the ability to handle multiple priorities across national and international ...
India, Gurugram
View vacancy401k
... do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based ...
India, Bengaluru
View vacancy... Safety Reports. - Conduct literature reviews and analyze scientific and clinical data to support document development. - Ensure documents comply with ICH-GCP, FDA, EMA, client requirements, SOPs, and regulatory guidelines. - Coordinate cross-functional reviews, manage document timelines, and incorporate stakeholder feedback. ...
10k
... trust ABBYY, including many Fortune 500 ones. You will work on further developing a portfolio already containing client names such as DHL, Johnson & Johnson, FDA, DMV, PwC, KeyBank, Spotify, and H&R BLOCK. The Technical Success Manager is the technical bridge between ABBYY's platform and the customer's architecture, workflows, ...
India, Bengaluru
View vacancy- Remote
- Hybrid
- On-site
- Contract
675k
... to our talent pipeline and considered should this role become available. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take ...
... • Flexibility to reprioritize workload to meet changing project timelines • Demonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and the organization's/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution ...