RA Operations Manager

Proclinical, in support of our client, are seeking an individual to fill the role of RA Operations Manager, based in San Francisco, CA. The successful candidate will help to establish the Submission Operation Management function, as well as an approach for regulatory submissions.

• Manage complex submission publishing activities associated with generating hard copy and electronic submissions.
• Deliver a service to our customers, through the planning, production, distribution and archiving of submissions throughout the various geographical regions.
• Lead strategic processes and provide strategic value to the overall positioning of the department.
• Lead and promotes initiatives in moving the company forward with the implementation of new systems, processes and services.
• Allocate project resource within the company and with offsite vendors to ensure adequate resourcing for regulatory dossiers
• Responsible for forward planning of publishing resources.
• Interact frequently with other functional areas.
• Maintain constructive and positive interactions with colleagues.
• Manage multiple projects and maintain oversight of the status of multiple projects managed by junior colleagues.
• Discuss status of ongoing projects with the team, sets expectations where necessary and reports on project statuses to senior management. Takes decisions regarding issue resolution.
• Describe complex issues and recommend a resolution or workaround to senior management with appropriate consideration of possible impacts.
• Represent Regulatory Operations by taking the lead in submission planning meetings to help becoming familiar with the submission priorities.
• Interface with project managers, regulatory product managers, and/or content authors to provide guidance on submission preparation and content.
• Assist and/or provide training to others on software tools and educate authors on publishing policies and procedures.
• Develop and manage projects as applicable in support of the Regulatory Operations department.
• Prepare and submit documents using regulatory/document management systems.
• Manage vendor relationships.

Skills And Qualifications

• BA/BS and 6+ years' experience OR non-degree experience of 8+ years.

• Significant experience within a Regulatory Publishing environment including hands on eCTD experience and broad industry standard systems knowledge.
• Management experience is preferred.
• Strong knowledge of Microsoft Office suite and Adobe Acrobat.
• Excellent written, verbal, and interpersonal communication skills.
• Balance multiple tasks to achieve goals and to meet deadlines and customers' expectations.
• Ability to communicate technical issues to a non-technical audience.
• Familiarity with pharmaceutical development and global Regulatory submissions is required.

To Apply:

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 call Tudor Carr at (+1) 617-545-5919 or upload your resume 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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