Title: Medical Writer - Labeling Specialist
Location: Indianola, PA 15051
Pay Rate: $42/hr on W2
Duration: 6 Months
DEPARTMENT/TEAM DESCRIPTION
Bayer Radiology Regulatory Affairs - Technical Publications Group is responsible for creating / maintaining compliant product labeling for our electro-mechanical (EM), sterile disposable (SD), and software products.
POSITION SUMMARY
We are looking for a reliable and detail-oriented individual to join our Technical Publications team based at the Indianola, PA site. Candidates must be available for an initial 6-month assignment. This position may turn into an extended assignment.
This individual will support and execute technical writing projects for Radiology device product labeling and operations manuals.
POSITION DUTIES & RESPONSIBILITIES
Throughout this assignment, the Labeling Specialist’s primary responsibility will be to:
1) Collect and assimilate technical information and accurately convey this information through clear and concise writing of instructions for use, standard operating procedures, and / or product labeling.
2) Use content management systems to develop and manage content and assembly
3) Coordinate the setup, approval, verification, and release of labeling in the Product Lifecycle Management application
4) Interface with other labeling specialists and labeling strategists to follow worldwide regulatory requirements and advise on labeling design and layouts
5) Produce accurate product labeling and design control documentation with supervision, within project schedules to avoid delays in new product launches and with consistent branding standards
A successful candidate will:
• Be detail oriented, having the ability to focus on details while still seeing the broader picture,
• Be expected to quickly learn labeling requirements and adapt in a dynamic labeling environment to maintain product compliance,
• Be expected to work well autonomously and as part of a collaborative team,
• Demonstrate interpersonal and communication skills, including an ability to establish good working relationships with diverse individuals,
• Manage time well and prove ability to meet deadlines,
• Have strong organizational skills to track labeling verification activities and status and communicate that information to project teams, and
• Be proactive in identifying labeling issues / discrepancies.
REQUIREMENTS/PREFERENCES
• Minimum 5 years of experience working in a regulated industry.
• Bachelor’s degree in an Engineering, Science, Graphic Design, or Professional / Technical Writing discipline.anth
• Experience using Microsoft Office and other technical software.
• May have experience with Technical Writing or Content Management Systems.
• May have experience using Adobe FrameMaker, Adobe Illustrator, CorelDraw, and / or XML-language experience.