The successful candidate will provide a wide range of administrative support to the Clinical and Regulatory functions. Provide back-up administrative support to other company administrative professionals to ensure a team approach to company needs.
Responsibilities include (but are not limited to) :
- Organize logistics (including travel arrangements) and prepare materials for Investigator and Clinical Team meetings
- Copy, collate, prepare and ship clinical study binders for clinical sites
- Prepare and ship supplies and documents to support clinical studies
- Organize payment system and ensure timely payments to clinical sites and other vendors
- Working closely with in-house clinical trial managers (CTMs)
- Track distribution of investigational drug supply
- Format, prepare, and coordinate translations of study documentation
- Manage the administrative affairs of the department, including invoice processing, expense reports and departmental expenses, supply procurement, including review of expenses to consider cost saving opportunities.
- Format documents for regulatory submissions
- Prepare large regulatory submissions, including copying, collating, binding, QC submissions to FDA
- Maintain hard copy and electronic regulatory files
- Maintain supplies
- Provide backup administrative support to other administrative assistants and company executives.
- Ensure administrative professionals are working together as a team to meet company administrative needs.
- Shows strong initiative; positive, outgoing and upbeat attitude
- Ability to multi-task and work well under pressure with a calm demeanor, excellent organizational skills and ability to follow-through- ensuring no items are overlooked.
- Ability to exercise sound decision-making and good judgment
- Manage and prioritize multiple projects in a timely manner and meet deadlines
- Outstanding organizational, written and communication skills
- Demonstrate a high level of professionalism and able to work with many levels of management
- Effective organizational, project management, time management and event planning skills
- Must have a professional and respectful demeanor when interacting with internal or external customers, consultants and vendors
- BA/BS degree preferred
- Proven ability to use Microsoft Office Suite applications including Word, Excel, Outlook calendar and email, and PowerPoint; experience with presentation graphics helpful.
- Experience in the pharmaceutical or biotech industry
- Strong attention to detail