Hope you are doing well
I am Smith, working as a recruiter with Infotree Service Inc. I am currently working on "Technical Writer" position with Medtronic. I will appreciate your response at the earliest, as the managers tend to move fast! |
NOTE : SEND RESUMES WITH THESE DETAILS , Profiles with all mandatory details would be processed with TOP Priority
Name (First & Last) |
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Contact No. |
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Email ID |
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Current Location |
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Willing to Relocate if need |
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Work Visa Status, Expiry Date |
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Availability * How soon can you join? |
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Reason for change |
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Are you fine with drug and background check? |
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Skype ID |
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Last 4 Digit SSN No. |
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DOB(Day, Month) |
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Higher Education, Year of Completion |
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2 References of Manager, Team Lead with contact number, email id, project name
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Job Title | Technical Writer | |
Project Location | Mounds View,MN 55112 | |
Duration | 12+ months /Contract | |
Skills
POSITION DESCRIPTION:
This position will be responsible for supporting the development of medical device package labeling for the Cardiac Rhythm Heart Failure business and drive the consistency and accuracy of format and content across all products and locations.
Performs a wide variety of complex duties, under general supervision, in all areas related to labeling. Including but not limited to: developing label designs, design documentation including engineering change orders, proofreading, leading label review activities, maintaining and improving labeling processes and communicating to global stakeholders.
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POSITION RESPONSIBILITIES:
Provides project support and coordination of labeling changes interfacing with Marketing, R&D, Regulatory, Technical Communications, Legal, Package Engineering and site Operations
• Creates or supports development of various required labeling components, including labeling requirements plans, technical information charts, graphics and/or schematics, label formats and final product labels.
• Develops plan, manages and monitors timelines and process of new and revised labeling ensuring all deadlines are met
• Reviews, and releases labeling for product labels, cartons and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices.
• Understands applicable labeling regulations and standards in the US and/or abroad. Reviews labeling change information, and ensures that it is supported by and consistent with the regulations and data.
• Provides recommendations to the labeling development processes, quality, systems tools and/or policies.
• Coordinates the translations of non-IFU labeling through internal or external sources
• Provides input in creation of and compliance with standard guidelines and documented procedures for labeling creation, revision and overall document management
• Works with labeling system database(s) related to development of required label information
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BASIC QUALIFICATIONS:
• Experience developing/ reviewing labeling in a regulated industry
• Experience working with global teams
• Experience using labeling systems and advanced Microsoft Excel features
EDUCATION REQUIRED:
BA or BS Degree in English, Technical writing/Editing, Graphic design or a related field
YEARS OF EXPERIENCE
2 yrs labeling experience
SPECIALIZED KNOWLEDGE REQUIRED
§ Experience working with Adobe Illustrator and/or other graphic design programs
§ Experience working in Excel and other Microsoft Office programs
§ Comfortable learning and using new computer systems and programs
§ Experience in proofreading/editing
Thanks & Regards
Smith,
Sr. Technical Recruiter
Infotree Service Inc.
215 Ann Arbor Rd.
Suite 304
Plymouth, MI 48170
734-446-7070
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