Job Description

TOP 3 MUST HAVE SKILL SETS:     Minimum 3 years prior experience writing controlled process documentation in the bio/pharma or medical device industry (other regulated environments may be considered. Minimum 3 years leading cross-functional teams/subject matter experts. Advanced Word, Excel.

DAY DAY RESPONSIBILITIES:     Day tday responsibilities will vary by project and day and will include a combination of the following: Work independently tedit, format and/or write SOPs or Work Instructions based on a process map or QC/revise existing documentation according ttemplate/style guide act as “scribe” writing documents according ttemplate/style guide during meetings with subject matter experts lead team of subject matter experts tfacilitate discussion and review of process and documentation with time, experience, and demonstrated ability, role may serve as a project manager tlead projects representing R&D Quality processes from beginning tend including strategy for process documentation and oversight of documentation

SUMMARY Minimum 3 years prior experience writing controlled process documentation in the bio/pharma or medical device industry (other regulated environments may be considered. Minimum 3 years leading cross-functional teams/subject matter experts. Advanced Word, Excel.

Document Management Specialist The primary responsibilities of the Document Management Specialist may include but are not limited tthe following: Development (creation of revision) of controlled documents such as Standard Operating Procedures, Work Instructions, Forms, guidance and related business process documentation tsupport regulatory and business requirements and the Research &Development (R&D) Quality Management System. This will require: Project management experience and the ability twork ttight timelines whilst maintaining quality and dealing with multiple projects Collaboration with subject matter experts and interpretation of their input Utilization of process models Compliance with internal procedures (eg, Style Guide) Strong attention tdetail during writing, review, revision, formatting and Quality Control of documents and related information The ability ttrack progress and tprovide regular status reports tachieve goals and meet deadlines Issue and conflict resolution Utilization of electronic document repository Advanced skills in Word and Excel. Knowledge of English grammar and ability twrite clearly and concisely. Serving as a subject matter expert and point of contact for R&D Quality processes.

Preferred Experience: project managed/led a cross-functional team of subject matter experts tdrive R&D Quality document processes including generation and management of Smartsheet, identifying Quality strategy, oversight of process modeling, and oversight/generation of process documentation. Knowledge of Quality Management Systems

Required Skills: (advanced) Word, MS Outlook, Excel, and electronic document management repositories. MS Project and Visiexperience preferred. At least 3 years prior experience specifically as a technical/business writer for writing controlled process documentation (eg, SOPs, Work Instructions) in the bio/pharma or medical device industry (other regulated environments may be considered) Excellent verbal and written communication skills/writing skills; active listening skills; attention tdetail. strong process/business writing skills Strong analytic/critical-thinking and decision making abilities Candidate should have critical thinking skills whis able twork independently with little direction. Must be flexible and able tmanage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment Prior experience leading cross-functional team/subject matter experts.