Job Posting: Regulatory and Scientific Analyst, Amarex Clinical Research
Amarex is an equal opportunity employer, offering competitive salaries and excellent benefits. Amarex is currently searching for dedicated and talented individuals for a Regulatory and Scientific Analyst.
The Regulatory and Scientific Analyst performs all activities related to development, preparation, writing, reviewing and editing of integrated reviews of literature and related materials that summarize data from published papers and clinical studies for submission to clients, the FDA and other regulatory agencies. Participates in site selection and conducts other tasks as assigned.
Responsibilities:
- Write technical reports summarizing scientific papers and clinical/non-clinical study reports.
- Write clinical study reports and coordinate document preparation for submission to regulatory agencies, including IND, NDA, IDE and PMA items.
- Assist in reviewing, developing, writing, and/or editing Investigator Brochures, annual reports and clinical protocols.
- Prepare and integrate tables, graphs, and graphics for all documents.
- Responsible for creating and editing all sections of IND and NDA documents/submissions.
- Prepare and submit regulatory filing (DMF, IND, BLA, PMA, 510k) and supports program for electronic formatting of regulatory submissions.
- Review reports, tables and listings for completeness and accuracy.
- Interact with various departments to collect information and synthesize it into documents.
- Develop procedures for new projects and provide guidance to other personnel or consultants.
- Write study protocols with reference to current research and FDA guidelines.
- Keep updated guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents, including ICH Guidelines.
- Act as a member of study teams, clinical project teams and interdepartmental project teams.
- Work with outside and internal database managers and statisticians to obtain data listings and analyses needed to support the preparation of Clinical Study Report/ publications.
Qualifications:
- MS/PhD degree with experience in publishing scientific papers in peer-reviewed journals.
- Two plus years experience in writing and preparation of clinical study reports phase I thru III and regulatory submissions is preferred.
- Strong presentation skills and analytical skills.
- Strong verbal and written communication skills.
- Strong Microsoft Office skills particularly in MS Word and Excel.
- Extremely detail-oriented with excellent follow-up skills.
- Ability to work independently with minimal supervision.
If you would like to submit your CV for our consideration, please forward it to: jobs@amarexcro.com.
Read more about Amerex at https://www.amarexcro.com/advantages.html.