Regulatory Operations Associate
ProClinical is advertising a vacancy for a Regulatory Operations Associate position with a leading biopharmaceutical company whose scientific research has resulted in 15 marketed products that benefit hundreds of thousands of people, along with a pipeline of late-stage drug candidates and unmatched patient access programs. This prestigious organisation is seeking for a driven and motivated applicant to join their team in Washington.
The Regulatory Operations Associate will interact with management and team members to perform document formatting and compilation activities associated with preparing documents for submissions in accordance with global regulatory guidelines.
- Coordinating the EndNote referencing process in terms of managing entries into the EndNote database, generating within-document bibliographies and providing individual assistant to document authors.
- Obtaining cited references and ensuring entry into the Reference Repository in submission-acceptable format.
- Assisting with the compilation of routine documents such as clinical study reports.
- Participating in supporting and promoting current electronic initiatives in moving the company forward with electronic submissions and electronic archives.
- Participating in the development or upgrading of templates, as well as guidance documents and SOPs that relate to document standards, content, and processes.
- Interfacing with project managers, regulatory product managers, and/or content authors to provide guidance on submission preparation and content.
- Maintaining constructive and positive interactions with colleagues.
- Performing document formatting activities, the Regulatory Operations Associate may assist with the development and management of projects applicable in support of the Regulatory Operations department.
Skills and Requirements:
- At least BA/BS in a relevant scientific field, although an MS is preferred.
- Experience with document management.
- Experience in PDF/hyperlinking.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
- Mid-Senior Level.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Sherron Howard at +267 435 8600 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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