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Regulatory Affairs Associate - I
Ref No.: 18-07900
Location: Seattle, Washington
Start Date / End Date: 07/02/2018 to 03/01/2019

Job Title: Regulatory Affairs Associate - I
Duration: 9 months
Location: Seattle, WA- 98102

***Same Dept as Req #4776. If your candidate had been submitted to that req, please do not submit to this one***

Job Description:
 
Regulatory Operations Associate - Document Processing
 
 
Specific Responsibilities:
 
  • 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.
  • The ideal candidate will possess experience working in the life sciences.
  • Including work with electronic document management systems, document control, regulatory submissions, work with clinical or quality documentation, or other experience directly related to Regulatory Operations.
  • Expertise in the use of document management and complex Word formatting experience is highly desired.
  • Entry level candidates will be considered but must have a strong working knowledge of MS Word, Word templates, Adobe Acrobat and standard Office tools.
 
Essential Duties and Job Functions:
 
  • As a member of the Regulatory Operations team, this position prepares and completes a variety of document formatting and compilation activities.
  • Works closely with authors in Medical Writing, Clinical and Regulatory Affairs to perform routine general formatting, template adherence, ToC generation, version control and non-routine document processing activities associated with the preparation of submission-standard regulatory documents for both hard copy and electronic submissions.
  • Coordinates the endnote referencing process in terms of managing entries into the endnote database, generating within-document bibliographies and providing individual assistance to document authors
  • Obtains cited references and ensures entry into the Reference Repository in submission acceptable format.
  • Assists with the compilation of routine documents such as clinical study reports.
  • Participates in supporting and promoting current electronic initiatives in moving the company forward with electronic submissions and electronic archives.
  • Participates in the development or upgrading of templates as well as guidance documents and SOPs that relate to document standards, content and processes.
  • Will interface with project managers, regulatory product managers, and or content authors to provide guidance on submission preparation and content.
  • In addition to document formatting activities, and may assist with the development and management of projects as applicable in support of the Regulatory Operations department.
  • Maintains constructive and positive interactions with colleagues.
 
Knowledge, Experience and Skills:
 
  • Typically requires a BA/BS with 2+ years of relevant experience or an MS with 1+ years of relevant experience.
  • Experience in document management and complex document formatting as applicable is a plus.
  • Familiarity with pharmaceutical development and regulatory submissions is a plus.
  • Must have excellent verbal and written skills, strong organizational and time management skills and strong attention to detail.
  • Must be able to balance multiple tasks simultaneously to achieve goals and satisfy customers.
  • Works under limited direction and may independently determine and develop approaches to non-routine problems.
  • Must possess flexibility to work effectively within an environment that has quickly changing processes, priorities and deadlines.


Apply on-line for immediate consideration, please send your updated resume and contact info via
 Contact: Rashmi M
Email: rashmi@sunrisesys.com | Phone: 732 272 0331