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Highlights: MS Word expert/guru with preference on exp in PDF/hyperlinking Must be competent in communicating with dept customers and high attention to detail Document management exp preferred 1st shift hours and flexible on start/stop time Specific ...

Job Description

Highlights: 

MS Word expert/guru with preference on exp in PDF/hyperlinking 
Must be competent in communicating with dept customers and high attention to detail 
Document management exp preferred 
1st shift hours and flexible on start/stop time 

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.