Location: Cambridge, MA
Length: Minimum 6-month contract w/ extension possibilities
Role: Submissions Manager, Regulatory Operations
Work days & hours:
- The hiring manager is looking for someone able to work Thursday - Monday
- (Tuesday & Wednesday are the days off)
- Work hours on weekdays are 2PM - 10 PM and weekend hours are 10AM - 6 PM.
Key Responsibilities:
- Oversee the planning, managing, and tracking of regulatory submissions
- Act as SME in regulatory operations to cross-functional project teams and the document management system
- Handle activities regarding publishing vendors in preparation of submission packages delivered to health agencies
- Manage the compilation of regulatory submissions, including coordinating the distribution and collecting product life-cycle information
- Ensure awareness and knowledge of e-submissions to the project team
- Lead and manage special projects as necessary
Qualifications:
- Bachelor's degree, preferred in sciences or systems technology
- Minimum 4 years of pharmaceutical experience
- Expertise in industry trends for dossier preparation (INDs, CTAs) and global submission standards (FDA, Health Canada, EMA, ICH, etc)
- Knowledge of CDISC (ADaM and SDTM)
- Prior experience in leading cross-functional groups
- Proficient in Microsoft Office
If you're interested, apply now! Must be local to Cambridge/Boston area.
