Role: Publication/Programme Consultant
Contact: ahmed@elemed.eu
Contract Length: 6 months
Location: Remote (US)
🔹Responsibilities
• Support US FDA drug submissions, with a focus on Investigational New Drug (IND) applications.
• Ensure compliance with all relevant FDA drug submission guidelines and standards
🔹 Requirements :
• Familiar with the process of preparing, submitting, and maintaining INDs (Investigational New Drug)
• In particular - Form FDA 1571 (IND application) and Form FDA 1572 (Statement of Investigator)
• Knowledge of the eCTD format for electronic submission of INDs is essential, as all submissions to the FDA must now be in eCTD format.
• Knowledge of accelerated approval, breakthrough therapy, and priority review pathways for IND applications is beneficial, especially if the project involves fast-tracking approval for urgent therapies
• Understanding of the FDA’s expectations for clinical protocols, including safety, efficacy, and risk assessment requirements.
• Experience working within the Pharmaceutical/Biotechnology/Medical Device industry
Nice to have:
• Understanding of ICH E6 (R2) – Good Clinical Practice (GCP), which outlines ethical and scientific quality standards for designing, conducting, and reporting clinical trials that involve human subjects.
✉️ If you are interested in this exciting role, please send your application directly to ahmed@elemed.eu
📲 Would you like to find out more about our open opportunities? Visit https://www.elemed.eu/vacancies/
Please note: Only candidates meeting the requirements set out in the role profile above, will be considered in the application process.
Due to the high volume of applications we receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful.
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🩺 Elemed is Europe’s leading MedTech technical recruiter. We serve within the Medical device, diagnostic and combination device arena, working with Managers up to VP of Quality and Regulatory. Our team helps medical device experts of today become leaders of tomorrow.
📣 We won Best International Recruitment Agency at the Recruiter Awards 2021.
At Elemed, we recruit exceptional people that solve regulatory and compliance problems, so patients can have access to safe, innovative and life-changing Medical Devices.
⚖️ We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Location: Anywhere
Posted: Oct. 17, 2024, 9:16 p.m.
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