Job Information
About the Position
Job Summary
The Scientific Technical Writer provides an important role in the support of Research and Development Department by creating and revising Technical Documents that are in compliance with IVD quality standards and regulations. In addition, the Scientific Technical Writer provides training/assistance to other Scientists involved in drafting Technical Documents.
Key Accountabilities
- Create and revise Technical Documents including Protocols, Reports, Design Input Requirements, and other Technical Documents related to Product Development and Design Control.
- Manage the revision of design control documents; ensure the accuracy, adequacy and consistency of documents.
- Collaborate with multidisciplinary teams to understand different aspects of Product Development and provide writing knowledge to the Design Control documents to ensure compliance with IVD standards.
- Work with Subject Matter Experts (SMEs) to gather information to create or revise documents.
- Assist with maintaining the DHF to ensure Documentation is up to date and accurate.
Networking/Key relationships
To be determined based on department needs, to include interactions such as:
- Mainly with R&D, Regulatory Affairs and Design Quality colleagues
Minimum Knowledge & Experience required for the position:
Education:
- Required: Bachelor's degree (Diplomatura) in the biological or related sciences.
- Valuable: Any additional degree higher than the required.
Experience:
- At least four (4) years of experience with technical, scientific, or medical writing in an academic medical environment, a pharmaceutical environment, a biotechnology company environment, an in vitro diagnostic environment or the equivalent.
Additional Skills/Knowledge:
- High level proficiency with Microsoft Word; proficient with Microsoft Excel and Powerpoint and with Adobe Acrobat. Valuable Basic Knowledge in SAP
- Language: Fluency in Spanish or Catalan. Fluency in English (reading, speaking and writing)
- Standards: Valuable knowledge of Quality Standards and of EU and US regulatory requirements for IVDs.
Skills & Capabilities:
- Strong attention to detail and accuracy
- Teamwork and interpersonal skills. Flexibility in order to work with, and provide support for a number of people
- Oral and written communication skills
- Time management skills. Excellent organizational and multi-tasking skills
- Thorough knowledge of Design Control processes and familiarity with Quality Standards as required
- Excellent analytical skills
- Able to work independently with moderate guidance
- Ability to adapt to R&D flexible and changing environment
- Reflect values of Werfen and OEM in the quality of work and working relationship
Travel requirements:
Sporadic travel may be required.
Individual Contributor Core Competencies:
Managing Work
Emotional Intelligence Essentials
Building Partnerships
Decision Making
Continuous Improvement
Continuous Learning
