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Job Requirements of Global Regulatory Sciences Manager:
-
Employment Type:
Contractor
-
Location:
Cambridge, MA (Onsite)
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Global Regulatory Sciences Manager
Careers Integrated Resources Inc
Cambridge, MA (Onsite)
Contractor
Job Title: Global Regulatory Sciences Manager
Location: Cambridge, MA
Duration: 3 Months+
Schedule: In office minimum 3 - 4 days a week to start
Pay range: $70 - $75/hr. on W2
Duties:
Education:
Skills:
Location: Cambridge, MA
Duration: 3 Months+
Schedule: In office minimum 3 - 4 days a week to start
Pay range: $70 - $75/hr. on W2
Duties:
- Support line manager with the day-to-day management of regulatory aspects of at least one clinical development program
- Responsible for relevant submissions for assigned program(s).
- Represent the Global Regulatory Sciences function on cross functional teams
- Support line manager in developing and implementing long and short-term product regulatory strategies/plans
- Plan for and lead preparation efforts for health authority meetings
- Provide guidance to external vendors and consultants as needed
- Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs
Education:
- Bachelor s degree in scientific discipline; advanced scientific related degree a plus
- 4 years or more in drug development; direct Regulatory experience is a plus
- Experience in oncology/rare diseases drug development a plus
- Ideally experienced in filing and managing INDs to FDA
- Working knowledge of drug development process and US regulatory requirements required; knowledge of EU, Canada, ROW, and post-marketing regulatory requirements a plus
Skills:
- Excellent interpersonal and communication skills. Ability to establish and maintain professional and productive working relationships
- Well organized, with an attention to details and capable of managing multiple deliverables
- A collaborator who communicates in an open, clear, complete, timely and consistent manner
- At home in a results-driven, highly accountable environment where you can make a clear impact
- A team player, who listens effectively and invites response and discussion
- Flexible and adaptable in ambiguous situations
- Must be proficient in Microsoft WORD, Excel, PowerPoint as well as SmartSheet and Adobe Acrobat
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