Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at USAMMDA . If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team.
We are currently seeking a Regulatory Affairs Scientist for the Frederick, Maryland area.
This position requires broad experience in medical product development and the regulatory process that is a part of it.
The primary role is to serve as a core member of integrated product teams (IPTs) and team leader of internal regulatory teams, and includes: review, editing, and coordination of document submissions to the FDA; identifying regulatory issues that need input of other regulatory Subject Matter Experts and obtaining that input; aiding with clinical and nonclinical protocol development and review; providing guidance and regulatory strategy; coaching Integrated Product Teams in the conduct of meetings with the FDA; and serving as a point-of-contact with regulatory staff of external collaborators.
Serve as the regulatory affairs point of contact for product development teams, FDA, and regulatory staff of external collaborators on designated products.
Identify and provide guidance to product managers on key regulatory issues and strategy.
Develop responses to FDA questions, review and edit regulatory documents in conjunction with product managers and regulatory team.
Assist in collection of documents, management and oversight to sponsor regulatory files of assigned products.
Prepare SOPs and work instructions for support activities.
Provide technical assistance to CRM Headquarters as needed and participate on proposal writing projects when requested.
Provide all job-related progress reports/technical reports as requested.
Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
Performs other duties as required and assigned.
Must be able to work independently following a brief period of specific technical training.
Possess a minimum of a master's degree in biomedical science or equivalent experience.
Prior experience as an FDA regulatory scientist or experience representing a sponsor before the FDA is necessary.
Demonstrate experience in advising product development teams on regulatory issues.
Demonstrate an understanding of the FDA eCTD processes.
Demonstrate skills in coordination of regulatory activities within internal and external teams.
Demonstrate training and experience in GLP studies and GCP Regulations.
Demonstrate experience in medical product development.
Demonstrate the ability to work well with personnel of diverse backgrounds and experience; manage conflict constructively.
Possess strong verbal and written communication skills.
Required Knowledge, Skills and Abilities: knowledge of applicable highly complex scientific/office procedures and techniques relating to position.
Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.
ClinicalRM is an Affirmative Action-Equal Opportunity Employer
“NorthCoast 99” Best Places to Work recipient
Clinical Research Management - 8 months ago