Compliance and Document Specialist/Medical Writer

SUMMARY:
Assists with and coordinates the preparation and quality control of policies, procedures and associated controlled documentation to be used for conduct of business in safety, regulatory, external medical communication and quality assurance organizations, that is in compliance with regulations, laws, company policy and best practices. The responsibilities include performing quality control checks for all documents produced for consistency and standards. Assisting process documentation designer with development, revision, maintenance and oversight of specific activities, such as mapping process flows, form design, and document management in the electronic repository.

RESPONSIBILITIES:
Establish documentation standards and internal processes for consistency and compliance within a controlled regulatory environment; Complete quality checks by following internal processes and established standards within timelines; Providing support on mapping process flows and SOP form design; Consistent management of all deadlines in accordance with set project plans by determining and prioritizing all tasks involved for timely completion; Provide accurate guidance and information to process documentation designers on documentation standards; Support documentation life cycle within the electronic repository to maintain a state of inspection readiness; Support process documentation designer(s) with Quality Standards and Training communications and other projects as assigned; Support communication of the process related information; Work directly with process documentation designers and trainers; Technology Initiatives; Other Projects.

REQUIREMENTS:
Demonstrated ability to manage tasks from multiple process documentation designers and meet targeted deliverables and deadlines by prioritizing and using short term planning skills; Understanding of a controlled documentation management system and industry standards for compliance; Strong verbal and written communication skills; Strong orientation to detail and ability to function and communicate issues to process documentation designers and direct manager; Training or experience in policy and SOP documentation quality control; Ability to work effectively and contribute proactively in a team-based environment as well as in partnership with colleagues, customers, and stakeholders; Demonstrated ability to adapt to changing situations and work well under pressure.

PREFERRED SKILLS:
Good communication and written skills; Detail-oriented; Ability to multi-task and prioritize multiple assignments; Experience working with multiple members of a department on various projects.

REQUIRED COMPUTER EXPERIENCE:
Knowledge of Windows NT/2000; Proficiency in Microsoft Office (Excel, Word, PowerPoint, Project); Process mapping tools (VISIO); Experience with database maintenance and data entry, particularly Microsoft Access; Proficiency in Documentum-based environments.

SKILLS
MS Visio, MS Excel, MS Outlook

Synectics is an Equal Opportunity Employer.