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Job Posting

Requirements:

Excellent English language communication and writing skills.

Bachelor's degree in engineering with 5 to 9 years of technical writing experience.

Extensive knowledge of Document Development Life Cycle (DDLC), structured authoring, content reuse, and single-sourcing.

Proficiency in content authoring, publishing, and governance tools such as MS WORD, DIT...

","shortDescription","

Job Posting

Requirements:

Excellent English language communication and writing skills.

Bachelor's degree in engineering w...","promoted","title","Technical Writer Job at Omni Inclusive in Boston","duration","","experienceLevel","displayThumbnail","location","locations",[64],"id",["B","3168332076"],"displayHeadline","Work at Omni Inclusive","category","Writing & Editing","displayPublishedAt","1 hours ago","displayUrl","/jobs/3168332076-technical-writer-job-at-omni-inclusive-in-boston","shortTitle","shortLocation","Boston, MA, United States","searchCompanyPath","/jobs?keyword=Omni+Inclusive","searchLocationPath","/jobs?location=Boston%2C+MA%2C+United+States","searchTitlePath","/jobs?keyword=Technical+Writer+Job+at+Omni+Inclusive+in+Boston",{"_65":66,"_67":68,"_69":70,"_71":72,"_73":74},"country","United States","city","Boston","formatted","Boston, MA, United States, 02298","state","MA","postal_code","02298",["D",1775571390000],"Job Posting

Requirements:\nExcellent English language communication and writing skills.\nBachelor's degree in engineering with 5 to 9 years of technical writing experience.\nExtensive knowledge of Document Development Life Cycle (DDLC), structured authoring, content reuse, and single-sourcing.\nProficiency in content authoring, publishing, and governance tools such as MS WORD, DIT...","Job Posting

Requirements:\nExcellent English language communication and writing skills.\nBachelor's degree in engineering with 5 to 9 years ...",[81],["B","3159014908"],"/jobs/3159014908-technical-writer-job-at-omni-inclusive-in-boston",{"_65":66,"_67":68,"_69":70,"_71":72,"_73":74},["D",1775571390000],"TalentBurst, an Inc 5000 company","

Medical Writer IV

Duration: 6-12 months from the start date of the worker with possibility to extend contract

Location: St. Paul, MN; Santa Clara, CA; or remote

Onsite or Remote Role-

Schedule: 8 to 5 in respective time zone; if not in PST time zone, occasional meetings after 5 pm might be required.

Top 3 Skills or Any Specific type of Experience you are looking for:

* Experience writing Medical Device MDR compliant CERs, CEPs and SSCPs

*Microsoft Office proficiency

*Vascular or other medical device experience such as Clinical Study

Management

*Education: A bachelor's degree is required along with 6-8 years of

experience.

Excellent analytical abilities with strong organizational and time management skills

Role Overview:

We are currently seeking a Clinical Evaluation Reporting (CER) / Medical Writer specializing in vascular medical devices. This role is part of the Regulatory Clinical Evaluation team and involves providing both technical and strategic writing support throughout the product development lifecycle.

The primary responsibility is the development of Clinical Evaluation Reports and related documentation for vascular products. The ideal candidate will have experience in clinical study design and management, scientific or medical writing, and/or quality engineering or risk management, along with strong communication skills.

Key Responsibilities:

Author and contribute to Clinical Evaluation documentation, including Plans/Reports (CER/CEP), PMS and PMCF Plans/Reports, SSCPs, and regulatory responses
Review, evaluate, and summarize clinical data from sources such as clinical trials, published literature, post-market surveillance, and risk assessments
Analyze data to support regulatory submissions and product approvals
Collaborate with internal teams and stakeholders to plan and execute CER-related projects
Support additional deliverables across clinical, regulatory, quality, and engineering functions as needed
Work closely with cross-functional teams including Sales & Marketing, R&D, Regulatory Affairs, Clinical Affairs, Quality Engineering, Risk Management, and Medical Affairs
Maintain in-depth knowledge of assigned products and identify relevant data sources for evaluation
Review and ensure alignment across documents such as IFUs, patient guides, risk management files, and training materials
Contribute to responses for regulatory queries and notified body questions
Prepare documentation for regulatory submissions, risk assessments, and compliance processes
Ensure high-quality, accurate, and consistent documentation aligned with internal standards and regulatory requirements
Maintain compliance with applicable regulations and standards such as ISO 13485, ISO 14155, ISO 14971, MEDDEV 2.7.1, MDR, and FDA/EU guidelines

Education and Experience:

Required:

Bachelor's degree or equivalent practical experience
6–8 years of medical writing experience in healthcare/pharmaceutical industries or 8+ years in technical writing
Experience across medical, pharmaceutical, medical device, or clinical research domains

Preferred:

Degree in biomedical sciences, medicine, or a related field
CER writing experience
Strong communication and interpersonal skills
Experience working in cross-functional teams
Strong analytical and multitasking capabilities with effective time management
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook

","

Medical Writer IV

Duration: 6-12 months from the start date of the worker with possibility to extend contract
1 to 3 years of significant engineering experience in the medical device field\nExperience in drafting protocols & report generation (including Data Analysis)\nExperience working in a medical device manufacturing environment\nPLM/PDM/ERP experience preferably Windchill\nGood experience in cross functional interactions & Good experience in technical writing skills\nGood communication skills","Job Title

1 to 3 years of significant engineering experience in the medical device field\nExperience in drafting protocols & report generat...","Technical Writer Job at Omni Inclusive in Santa Clara",[122],["B","3159014909"],"/jobs/3159014909-technical-writer-job-at-omni-inclusive-in-santa-clara","/jobs?keyword=Technical+Writer+Job+at+Omni+Inclusive+in+Santa+Clara",{"_65":66,"_67":97,"_69":98,"_71":99,"_73":100},8752,"name","Newsday Media Group","agency","logo","https://production-rails-default.s3.us-east-2.amazonaws.com/public/legacy-logos/351727.GIF","slug","newsday-media-group","

Newsday Media Group is a locally owned, independent media company grounded in journalistic excellence, integrity, and commitment to the communities it serves. With 19 Pulitzer Prizes and dozens of Emmy Awards, it's one of the most decorated news organizations in the country.

The company is in the middle of a significant transformation, expanding from its newspaper roots into a multimedia operation spanning digital, video, podcasts, live events, and data-driven civic engagement. NMG properties include the flagship Newsday and Newsday.com, NewsdayTV, the Newsday Live events series, and nextLI, a civic research and community forum platform funded by The Rauch Foundation.

A new 130,000-square-foot headquarters in Melville features a broadcast-quality TV studio and multimedia production space. Newsday Live produces a growing calendar of food and wine tastings, author talks, sports Q&As, concerts, and community events. Feed Me, the company's food and dining vertical, includes a web series, quarterly print magazine, and restaurant coverage. Brand 360, the in-house content studio, partners with advertisers across healthcare, education, energy, tourism, and retail.

Newsday's investigative unit has driven real-world change, from prompting schools to replace unsafe football helmets to contributing reporting that led to federal corruption convictions. Community programs include the Newsday Marching Band Festival, CheerFest, Scholar-Artist honors, and partnerships with local nonprofits focused on hunger, housing, youth education, and child welfare.

For people who care about local journalism, multimedia storytelling, and community impact, Newsday is doing the work at scale.

","Melville, NY","coloredLogo","logoAttachment","thumbnail","thumbnailAttachment","newsday.jpg","hexCode","#D52B1E","headline","Award-Winning Local Media Powerhouse Serving Long Island & New York City","/companies/newsday-media-group","https://production-rails-default.s3.amazonaws.com/uploads/company/thumbnail_attachment/8752/newsday.jpg",["B","3168332052"],["D",1775571390000],"indexedAt","
Job Title
1 to 3 years of significant engineering experience in the medical device field
Experience in drafting protocols & report generation (including Data Analysis)
Experience working in a medical device manufacturing environment
PLM/PDM/ERP experience preferably Windchill
Good experience in cross functional interactions & Good experience in technical writing skills
Good communication skills
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Job Title
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