Technical Writer

About you:

• Excellent verbal and written communication skills.
• Meticulous attention to detail and organizational skills.
• Demonstrated ability to interpret, distill, and disseminate relevant information.
• Ability to work effectively and collaboratively in a cross-disciplinary team environment to access and identify relevant technical information.
• Resourceful, flexible, and adaptable; no task is too big or too small.
• Ability to thrive in a dynamic and constantly changing environment.
• Willing and eager to go above and beyond/flexible schedule.

Key Qualifications:

• A minimum of a Bachelor’s degree in Life Sciences or Engineering. A Master’s, PhD, or MD is highly preferred.
• At least 3 years experience as a Technical writer. Experience in the medical device sector is highly preferred. 
• Proven experience in the preparation of study reports and regulatory submissions.
• Excellent attention to detail, including fact-checking, logical flow, parallelism, formatting, proofreading, and document structure.
• Ability to multitask, set priorities, and work effectively under pressure, with strong organizational and project management skills.
• Demonstrated ability to drive and see tasks through to completion.
• Excellent interpersonal and active listening skills; establishes and maintains productive working relationships with team members.
• Track record of consolidating, analyzing/interpreting, summarizing, and communicating data from multiple data sources effectively in writing to a variety of scientific and nonscientific audiences.
• Analytical ability to swiftly grasp and effectively communicate complex scientific and engineering concepts.
• Knowledge of how to use publicly available databases (e.g., PubMed, DailyMed, FDA, and EMA sources and guidelines) for literature and information mining to support document content and how to cite such information appropriately.
• Demonstrated proficiency with Google Workspace (Google Docs, Sheets, Slides), including template creation and version control.

Preferred Qualifications: 

• Experience with implantable Class III medical devices, preferably implantable neuromodulation devices.
• Working knowledge of US regulations related to medical devices and clinical trials (e.g., 21 CFR Part 820).

Examples of concrete duties:

• Create high-quality documents intended to support regulatory interactions and filings and meet regulatory submission standards. Work closely with Subject Matter Experts (SMEs), drive document management from start to finish (i.e., generation of a blank document to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing and managing various processes (document reviews, QC, QA, formatting, and document archiving).
• Critically review, interpret and conceptually organize results from complex submission-supporting studies, deriving clear, concise and scientifically accurate key messages/documents that support regulatory submission strategies.
• Provide editorial or review support for other types of documents, such as SOPs and user manuals.
• Collaborate with cross-functional team members (e.g., Robot, Brain Interfaces, BCI, and Clinical) to ensure accurate and timely completion/delivery of high-quality, scientifically supported documents.
• Provide editorial support, ensuring quality of all scientific content, with a focus on clarity, grammar, accuracy, and consistency, while maintaining adherence to proper format, regulatory requirements, and company guidelines/styles/drafting processes.
• Initiate and manage multiple rounds of document review and ensuing revisions, interacting positively and professionally with all levels of reviewers from SME to senior management, effectively resolving conflicts and building consensus, as necessary.
• Simultaneously manage multiple overlapping projects at different stages and on separate development programs and contribute to overall process improvement.
• Engage early with project teams and SMEs to plan and review tables, listings, and figures for assigned documents. Organize cross functional meetings to align on general strategy for content and authoring of documents.
• Maintain document history and manage version control of documents.
• Conduct comprehensive literature and data searches of external and internal sources, including literature from journals, using company systems and processes to support regulatory submissions.