Technical Writer II
hace 4 semanas
About the Role:
We are seeking a skilled Technical Writer II to join our team at Boston Scientific Corporation. As a Technical Writer II, you will be responsible for developing high-quality labeling content for our medical devices. This includes creating Instructions for Use (IFUs) and Product Information for Patients that are clear, concise, and compliant with regulatory requirements.
Your Responsibilities:
- Develop labeling deliverables, including IFUs and Product Information for Patients, ensuring clarity and consistency in the content.
- Write and edit labeling content to ensure it is accurate, concise, and effectively communicates the necessary information to the intended audience.
- Ensure compliance with regulatory requirements and internal standards by collaborating with regulatory affairs professionals and staying updated on regulatory changes and requirements.
- Collaborate with other functions within the organization to gather necessary information and ensure accuracy and consistency in labeling deliverables.
- Adhere to established procedures and workflows to maintain consistency and quality in labeling deliverables.
- Conduct thorough reviews of labeling deliverables to identify and correct any errors or inconsistencies.
- Strive for continuous improvement in labeling processes and content to enhance clarity, effectiveness, and compliance.
Requirements:
- Studies completed in English, English Teaching, Translation, or an applicable field (bachelor's degree or higher).
- English Level desired: C1 (90%) or above.
- Quality System requirements: In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Desired knowledge: Functional Knowledge, Business Expertise, Problem Solving, Leadership, Impact, Interactions & Communications.
- Regulatory Affairs: professionals with experience in regulatory affairs, especially those with knowledge of labeling regulations and guidelines specific to the medical devices industry.
- Medical Writing: individuals with a background in medical writing, particularly those with experience in creating patient-facing materials such as IFUs and Product Information for Patients.
What We Are Looking For:
We are looking for a highly skilled and experienced Technical Writer II who can develop high-quality labeling content that meets regulatory requirements and internal standards. If you have a strong background in medical writing, regulatory affairs, and quality systems, and are passionate about creating clear and concise content, we encourage you to apply for this role.
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