About the role:Under moderate supervision/guidance, brings clarity and consistency to Labeling deliverables (Instructions for Use and Product Information for Patients) through accurate and concise writing and effective use of English according to the technical/educational level of the end user. Collaborates with other functions (R&D, Design Assurance, Clinical, Medical, Regulatory Affairs, etc.) to ensure Labeling content is developed per, and compliant to, all applicable procedures, standards, and regulations. Your responsibilities include: Developing Labeling Deliverables: The primary responsibility would be to develop labeling deliverables, including Instructions for Use (IFUs) and Product Information for Patients, ensuring clarity and consistency in the content. This involves accurately translating technical information into language that is understandable for the end user. Writing and Editing: The individual would be responsible for writing and editing labeling content to ensure it is accurate, concise, and effectively communicates the necessary information to the intended audience. This includes reviewing and revising content as needed to improve clarity and readability. Ensuring Compliance: Compliance with regulatory requirements and internal standards is crucial in labeling. The individual would need to ensure that labeling content is developed and maintained in accordance with all applicable procedures, standards, and regulations. This may involve collaborating with regulatory affairs professionals to stay updated on regulatory changes and requirements. Collaboration: Collaboration with other functions within the organization is essential to ensure that labeling content meets all requirements and is aligned with product specifications. The individual would collaborate with teams such as R&D, Design Assurance, Clinical, Medical, and Regulatory Affairs to gather necessary information and ensure accuracy and consistency in labeling deliverables. Adhering to Procedures: Following established procedures and workflows is important to maintain consistency and quality in labeling deliverables. The individual would need to adhere to company procedures and guidelines for developing, reviewing, and approving labeling content. Quality Assurance: Ensuring the quality of labeling content is another key responsibility. This involves conducting thorough reviews of labeling deliverables to identify and correct any errors or inconsistencies. Attention to detail is crucial to maintain the accuracy and integrity of the content. Continuous Improvement: Striving for continuous improvement in labeling processes and content is important to enhance clarity, effectiveness, and compliance. The individual would be responsible for identifying areas for improvement and implementing changes as needed to optimize labeling deliverables. What we are looking for: Studies completed in English, English Teaching, Translation or 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. Candidates shall fulfill at least one of the following: Technical Writing: candidates with experience in technical writing, particularly in industries with stringent regulatory requirements such as pharmaceuticals, medical devices, biotechnology, or healthcare. Proven track record of producing clear and accurate technical documentation. 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 Instructions for Use (IFUs) and Product Information for Patients (also known as Patient Information Leaflets). Individuals shall be familiar with translating complex medical information into language that is understandable for patients. Quality Assurance/Quality Control: candidates with experience in quality assurance or quality control, particularly within regulated industries. Clinical Research: professionals with experience in clinical research, particularly those involved in writing study protocols, informed consent forms, and other clinical documents. Individuals shall be familiar with presenting complex scientific information in a comprehensible manner. Healthcare Professionals: individuals with backgrounds in healthcare professions such as nursing, pharmacy, or medicine. Individuals shall have firsthand experience communicating with patients and understanding their information needs. Requisition ID: 579523 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! Benefits • Life-Work Integration • Community • Career Growth At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life's work.
