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We're looking for a Senior Word Processing and Standards Medical Writing Manager
, working in Pharmaceuticals and Medical Products
industry in 1 Waukegan Road,, North Chicago, Illinois, 60064, United States
- Implement the development and maintenance of global clinical standards (including business processes, new systems, standards, templates, related initiatives) related to the submission process in support of the production of high quality, submission-ready documents.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- Bachelors degree in Science
- 8+ years relevant industry experience in medical
writing or a related area such as quality, regulatory, clinical
research, or product support/R&D
- Experience directly managing employees is required
- Experience in scheduling work and managing workload
(anticipated/unanticipated requests, time/resource management)
- Experience implementing the development and/or maintenance of
standardized training materials/tools, and the development of personnel
- Experience in developing/instituting standard procedures,
guidelines, and templates
- Expert level of knowledge and experience with
CTD (common technical documents) content templates in Pharma
understanding/working knowledge of MS Word
- Assessment, completion, and, reporting of metrics to management on a routine basis
- Knowledge of international regulations, requirements and guidance associated with document preparation and submissions
- Knowledge of current electronic document management systems and
information technology (e.g. DocXTools, eDocs, SharePoint)
experience in use of MS Office (e.g., Excel, OneNote, Outlook,
PowerPoint, Project, Word), and, Adobe Acrobat
- Developing strength in technical leadership and personal leadership; ability to influence current thinking
- Collaborative teamwork and leadership track record
business communication/presentation skills with aptitude for
summarization as well as detail orientation
- Ability to influence
without direct authority
- Ability to build and maintain positive
relationships internally and externally
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?