For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Project Administrator is responsible for supporting the scientific staff for the US Regulatory Sciences Consulting team by performing project-related duties and conducting in-depth reviews of client work products and regulatory submissions. The Project Administrator works closely with Regulatory Project Managers to ensure deadlines are met and project-specific processes are streamlined and standardized.
Essential Functions
- Proofread and format all deliverables (client reports and FDA submissions); coordinate with project team as needed, and handle submission organization.
- Create and manage templates to accommodate specialized submissions, internal forms/tracking mechanisms or client specific forms and templates.
- Provide training and Help Desk support to technical staff with Word/Excel as needed.
- Must be local to the Washington, DC office and will be required to be on site 1-2 days per week. Additionally, will be required to work in the office all days when client meetings are held (with adjusted working hours and meeting set up starting ~7 AM)
- Support in-office client meetings by coordinating travel, hotel accommodations, conference rooms, catering, meeting set-up/clean-up, and ad hoc tasks as required:
- Provide backup support for the ordering and file management of articles, books, FOIA requests, ISO standards, etc. which are requested by consulting staff as needed for their projects.
- Coordinating Special ad hoc requests, overhead projects/assignments as required.
Necessary Skills & Abilities
- Strong writing, editing, and proofreading experience.
- Proficiency in Microsoft Office with expert level in Word; strong PowerPoint and Excel skills.
- Able to work autonomously.
- Organized and detail-oriented with excellent time management skill.
- Must be nimble to shift priorities and manage the demands of varying project deadlines.
- Team-Player: Must be willing to pitch in when needed, even if something is out of scope of normal duties.
Educational Requirements
- BS/BA in Science, English, Publishing or other relevant/related field
Experience Requirements
- 3 or more years’ experience in a similar position (i.e., Document Specialist, Regulatory department for Pharmaceutical/Biotech firm, healthcare industry).
- Experience working on FDA submissions preferred.
Location: Hybrid role working 1 to 2 days weekly in Washington D.C. office
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
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What We Do
ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies.
With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risk and accelerate high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science