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Medical Writing Manager
Eingestellt von Real Staffing Group aus Frankfurt am Main
Gesuchte Skills: Support, Marketing
Projektbeschreibung
Keywords:
[REGULATORY AFFAIRS, REG. AFFAIRS, STRATEGY, RA, IND, NDA, ECTD, IMPD, CTA, IND AMENDMENTS, ANNUAL REPORTS, EUROPEAN, FDA, HEALTH AUTHORITY, INTERNATIONAL HEALTH AUTHORITIES,CMC, MODULE 1, MODULE 2, MODULE 3, MODULE 4, PRE-IND, STRATEGY, SUBMISSIONS, COMPLIANCE, MANAGEMENT,ECTD]
Title:
Senior Regulatory Affairs Associate
Role:
Reporting to the Director of Regulatory Affairs, you will plan, organize, and submit RA submissions in a timely manner, and contribute to much of the overall strategy. This is an extremely exciting opportunity in New Jersey offering a competitive salary as well as generous benefits. The position has strong focus on domestic submissions, and the right candidate should have experience with regulatory projects in a diverse range of therapeutic areas.
Responsibilities:
-Take lead roles in pre-IND meetings and FDA conference calls
- Contribute actively to NDA preparation
-Organize and maintain reporting schedules for regulatory applications
-Lead associates and train them to review and prepare basic regulatory documents.--Evaluates changes to regulatory documents and formulates strategies to maintain submission goals.
- Respond to queries from FDA associated with NDA submissions
- Independently review and provide feedback to the promotional review committee related to promotional marketing items.
- Provide strategic regulatory support to all functional groups in alliance projects with contract manufacturers.
-Represent RA on various product teams
- Create, organize and manage the preparation of all types of FDA submissions
Requirements:
-Minimum of BS degree, ideally an MS or advanced degree in related field
-At least 4 years of experience specifically in regulatory affairs
-Experience reviewing outgoing FDA correspondences
-Experience with INDs, NDAs, BLAs, and other regulatory submissions
-Prior experience interacting with the FDA
-Knowledge of eCTD publishing software preferred
-A strong analytic backgroundTo find out more about Real Staffing please visit www.realstaffing.com
[REGULATORY AFFAIRS, REG. AFFAIRS, STRATEGY, RA, IND, NDA, ECTD, IMPD, CTA, IND AMENDMENTS, ANNUAL REPORTS, EUROPEAN, FDA, HEALTH AUTHORITY, INTERNATIONAL HEALTH AUTHORITIES,CMC, MODULE 1, MODULE 2, MODULE 3, MODULE 4, PRE-IND, STRATEGY, SUBMISSIONS, COMPLIANCE, MANAGEMENT,ECTD]
Title:
Senior Regulatory Affairs Associate
Role:
Reporting to the Director of Regulatory Affairs, you will plan, organize, and submit RA submissions in a timely manner, and contribute to much of the overall strategy. This is an extremely exciting opportunity in New Jersey offering a competitive salary as well as generous benefits. The position has strong focus on domestic submissions, and the right candidate should have experience with regulatory projects in a diverse range of therapeutic areas.
Responsibilities:
-Take lead roles in pre-IND meetings and FDA conference calls
- Contribute actively to NDA preparation
-Organize and maintain reporting schedules for regulatory applications
-Lead associates and train them to review and prepare basic regulatory documents.--Evaluates changes to regulatory documents and formulates strategies to maintain submission goals.
- Respond to queries from FDA associated with NDA submissions
- Independently review and provide feedback to the promotional review committee related to promotional marketing items.
- Provide strategic regulatory support to all functional groups in alliance projects with contract manufacturers.
-Represent RA on various product teams
- Create, organize and manage the preparation of all types of FDA submissions
Requirements:
-Minimum of BS degree, ideally an MS or advanced degree in related field
-At least 4 years of experience specifically in regulatory affairs
-Experience reviewing outgoing FDA correspondences
-Experience with INDs, NDAs, BLAs, and other regulatory submissions
-Prior experience interacting with the FDA
-Knowledge of eCTD publishing software preferred
-A strong analytic backgroundTo find out more about Real Staffing please visit www.realstaffing.com
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Marketing/Vertrieb, Sonstiges