Bayer Diabetes Care: DITA Content Strategist

Bayer Diabetes Care (BDC) is looking for an individual who is keen to pair their solid understanding of DITA content strategy, development and publishing with management of all the aspects of medical device labeling including people, regulatory and translation.

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. Bayer HealthCare, an Equal Opportunity Employer, makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting science for a better life throughout everything that we do. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

DITA Content Strategist / Content Manager

Responsibilities of this role include:

Managing a team of writers responsible for creating the content required for packaging and labeling materials
Working with the Sr. Manager, Global Content to develop content models, metadata, reuse strategies and workflow
Setting the tone and structure of all content in accordance with DITA standards and content management system guidelines
Enforcing consistent implementation of content across brands
Managing project schedules and coordinating activities within the Content Department
Coordinating with Core Team Members including Legal, Medical, Regulatory within BDC to ensure that all labeling is submitted and approved by government regulatory agencies
Acting as liaison between Research and Development, Marketing and the Packaging Services team
Working closely with the Translation Project Manager to facilitate localization of core content into required languages
Working closely with the regulatory team to assure that regional/country requirements are defined within in the content management system
Coordinating proofreading and editing of all final English text for 510K and IVDD submittal

Skills Required

8-10 years of experience as a Technical Writer or Manager in a Pharmaceutical or Medical Device environment
5 or more years of experience with structured writing, preferably using DITA and a component content management system
Microsoft Office, Adobe Creative Suite, and Adobe FrameMaker knowledge a plus
Bachelor’s Degree in liberal arts, English major is desirable, or Bachelor’s degree in science or medical technology
Experience working with content in a government regulated industry
Foreign language skills and/or experience managing translation projects
Strong relationship building skills
Assertive and comfortable working across all levels of the organization
Highly organized and be able to manage multiple projects at any given time
Technical expertise to comprehend and manage complex technical information (software, instrument, and reagent systems) and the writing skills to transform this information into accurate, understandable publications
Analytical thinker with superior problem-solving skills
Thorough working knowledge and understanding of the FDA regulations as they apply to the preparation, distribution, and control of product labeling for in vitro diagnostics products
Experience managing outside agencies and freelance creative talent