Medical WriterExpert-Regulatory Affairs-RD-CH
Medical WriterExpert-Regulatory Affairs-RD-CH
Posted on :
13-10-2024
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Job Description
Overview:
Tekwissen Group is a workforce management provider throughout the USA and many other countries in the world. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world headquartered in Leverkusen and areas of business include pharmaceuticals; consumer healthcare products agricultural chemicals seeds and biotechnology products.
Job Title: Medical Writer(Expert)Regulatory AffairsR&DCH
Location: Indianola PA 15051
Duration: 6 Months
Job Type: Contract
Work Type: Hybrid
Job Description:
POSITION SUMMARY
- We are looking for a reliable and detailoriented individual to join our Technical Publications team based at the Indianola PA site.
- Candidates must be available for an initial 6month assignment.
- This position may turn into an extended assignment.
- This individual will support and execute technical writing projects for Radiology device product labelling and operations manuals.
POSITION DUTIES & RESPONSIBILITIES
- Throughout this assignment the Labelling Specialists primary responsibility will be to:
- 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 labelling.
- Use content management systems to develop and manage content and assembly
- Coordinate the setup approval verification and release of labeling in the Product Lifecycle Management application
- Interface with other labeling specialists and labeling strategists to follow worldwide regulatory requirements and advise on labeling design and layouts
- 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.
- Bachelors 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 XMLlanguage experience.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Employment Type
Full Time
Key Skills
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