Title: Senior Medical Writer (Remote) Location: Remote USA - Florida, Requisition ID 65196 - Regulatory Affairs - Arthrex, Inc. - Medical Writing - Regulatory Affairs - Regulatory Affairs -Remote USA - Florida Job Description: Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a (Senior Medical Writer who is responsible for managing specific aspects of the Arthrex Regulatory Affairs Medical Writing program with an emphasis on supporting regulatory approval/clearance/licensure for medical devices in the most efficient, compliant manner. This position will play a critical role in regulatory approval efforts for international markets. This role will specialize in writing, editing, and reviewing clinical regulatory documents as well as support and execute general medical writing activities. These activities include performing systematic literature reviews, as well as writing Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) plans and evaluation reports, Summary of Safety and Clinical Performance (SSCP) reports, Post-market Surveillance (PMS) plans, Post-market Surveillance reports (PMSRs), and Periodic Safety Update reports (PSURs) in accordance with global regulatory requirements to support Arthrex’s regulatory compliance and global market sales. The Medical Writer will work closely with cross-functional teams (Regulatory, Clinical, Quality, Marketing) to ensure successful preparation of high-quality submission-ready clinical documents that lead to and maintain regulatory approval/clearance/licensure for Arthrex’s medical devices. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™. This position is eligible for remote work. Essential Duties and Responsibilities: - Perform systematic literature searches and reviews for clinical regulatory document creation. Interpret and synthesize literature information for use in clinical regulatory documents. - Compile clinical evidence from multiple sources such as current and past clinical trials, post market clinical follow up data and literature review updates, ad-hoc analysis, meta analyses, or other sources of safety and performance data (e.g. IIS clinical data, as available) and synthesize the information to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification, and proposed indication/labeling change. - Write, edit, and proofread Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) plans and evaluation reports, Summary of Safety and Clinical Performance (SSCP), Post-market Surveillance (PMS) plans, Post-market Surveillance reports (PMSRs), and Periodic Safety Update reports (PSURs) in accordance with regulatory requirements. Maintain periodic updates, perform gap analysis, and revise existing documents as necessary. - Work in a cross-functional team to establish clinical study protocols and reports, data summaries from raw data and document strategies. Review clinical protocols to ensure collection of data is sufficient for regulatory submissions. - Work cross-functionally to ensure successful preparation of high-quality submission-ready clinical documentation. Communicate, as the primary liaison, with the Project Manager and other cross-functional teams, as applicable, to provide input and gather required information for assigned projects. - Evaluate the risk of proposed regulatory strategies in the context of sufficient clinical data and offer solutions as applicable. - Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation. - Review or edit clinical regulatory documentation for completeness, clarity, consistency and conformance to regulation, guidelines and internal policies/procedures to ensure all data and information is truthful, accurate, and verifiable against source documentation to confirm compliance and traceability. - Recommend changes to company procedures in response to changes in regulations, published guidance, and/or standards. - Assist in writing or updating standard operating procedures, work instructions, or policies. - Participate in internal or external audits, as required. - May develop or conduct employee training. Education and Expereince: - Bachelor’s degree in Life Science, Biological Science, or related discipline required. - 5 years relevant experience required in clinical medical writing within the life science industry. - EU MDR/MDD experience required. Reasoning Ability: Ability to identify and define problems, collect data, analyze established facts, draw valid conclusions, and effectively communicate the information both verbally and in writing to a variety of audiences. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to both appropriately format and develop a clear logic trail to establish conclusions based on an understanding of factual evidence. Ability to critically think; using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Ability to actively learn, understanding the implications of new information for both current and future problem-solving and decision-making. Abilities Requirements: Ability to comprehend principles of engineering, physiology and medical device use. Ability to handle master documents, drawings, specifications, regulatory and clinical documentation with a high degree of confidentiality. Ability to research, read, analyze, and interpret clinical and regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents. Ability to review, collate, describe and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events) to produce answers that make sense. Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments. Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally. Ability to work in a fast paced environment. Machine, Tools, and/or Equipment Skills: Proficiency in the use of personal computers and computer programs, particularly SAP, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company). Language and Communication Skills: Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures. Excellent written and oral communication skills required. Arthrex Benefits - Medical, Dental and Vision Insurance - Company-Provided Life Insurance - Voluntary Life Insurance - Flexible Spending Account (FSA) - Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) - Matching 401(k) Retirement Plan - Annual Bonus - Wellness Incentive Program - Free Onsite Medical Clinics - Free Onsite Lunch - Tuition Reimbursement Program - Trip of a Lifetime - Paid Parental Leave - Paid Time Off - Volunteer PTO - Employee Assistance Provider (EAP) All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.

Role Description Callnovo is seeking a detail-oriented and culturally aware Independent Content Writer / Content Specialist to support content creation for U.S.-market audiences. The successful candidate will independently research, organize, write, publish, and distribute content based on topics provided by clients. This role requires strong English writing skills, a solid understanding of U.S. culture and social trends, and the ability to use tools such as ChatGPT and mainstream search engines to collect, verify, and synthesize information. Key Responsibilities - Independently collect, organize, and write content based on topics provided by clients. - Use ChatGPT, search engines, and online resources to gather relevant information while ensuring content is objective, accurate, and authentic. - Create content that aligns with U.S. local culture, social context, and reader preferences. - Write general-interest content that is relatable, down-to-earth, and easy for readers to understand. - Manage content publishing and distribution to increase readership, engagement, and share rates. - Communicate with clients to understand content direction, adjust messaging, and improve communication effectiveness. - Deliver manuscripts on schedule while maintaining content quality and consistency. Qualifications - Bachelor’s degree or above. - Strong English writing ability, with the ability to write clear, engaging, and reader-friendly content. - Ability to quickly understand and present topics across multiple domains. - Familiarity with U.S. culture, social trends, and reader psychology. - Proficiency in using ChatGPT and mainstream search engines for research, information retrieval, and content synthesis. - Strong content communication mindset, with the ability to support content planning and distribution. - Detail-oriented, responsible, and able to meet deadlines. - Excellent communication skills and the ability to adapt to remote collaboration workflows. Preferred Qualifications - Degree in Journalism, Communication, Public Relations, or a related field. - Prior writing experience in traditional media, such as magazines, newspapers, or similar publications. - Experience creating content for U.S.-market audiences. - Experience managing or supporting content publishing and distribution. How to Apply Interested candidates are welcome to apply with their resume and writing samples. Please send your application to: hr@callnovo.com

Role Description Our client is based in the US and is a content creator / YouTuber who is currently expanding into a website blog to share stories about his travels and adventures. The website will feature content around travel, van life, camping, and other exploration experiences. It will also serve as a platform for affiliate marketing related to products he personally uses, such as van gear, cooking gear, pet gear, camping equipment, and more. They are currently looking for a highly skilled SEO Content Writer with excellent English proficiency who can produce high-quality, engaging content tailored for American audiences and websites. This role goes beyond traditional SEO writing. The ideal candidate should understand how to structure large-scale content ecosystems, organize content hierarchies, and contribute strategically to a platform designed around long-term audience growth and community building. 🚀 What Our Client Is Building: Our client is building a platform called Exploring Out Loud. This is not a traditional website. The goal is not simply to promote services or sell individual products. Instead, the platform is designed to: - Deliver high-value content - Build a strong community - Convert visitors into members (both free and paid) Qualifications - Excellent written English proficiency, especially for American audiences - Proven experience in SEO content writing and website content structuring - Strong understanding of SEO best practices, content hierarchy, and internal linking - Experience organizing large-scale content ecosystems (categories, tags, subcategories, page structures, etc.) - Strong research and content organization skills - Experience writing engaging, natural, and story-driven content - Interest or familiarity with travel, van life, camping, outdoor adventures, or lifestyle content is a plus - Experience working with affiliate/content-based websites is a plus Requirements - Write high-quality, natural English content - Structure content clearly and logically - Understand relationships between multiple content types - Think strategically about both SEO and user experience - Contribute to a platform designed for long-term membership growth and community building - Organize large-scale content systems effectively - Have knowledge and hands-on experience with Google Ads - Understand how SEO and paid traffic strategies can support overall website growth - Ability to work independently and contribute strategically in a fast-paced environment - Strong attention to detail and content consistency Benefits - Competitive salary - Work with fast-scaling, premium brands - Fully remote role with a dynamic, growth-driven team - Clear opportunities for career growth and advancement

Role Description Our client is a travel YouTuber behind the channel: Exploring Out Loud . They are currently looking for a highly skilled SEO Content Writer with excellent English proficiency who can produce high-quality, engaging content tailored for American audiences and websites. This role goes beyond traditional SEO writing. The ideal candidate should understand how to structure large-scale content ecosystems, organize content hierarchies, and contribute strategically to a platform designed around long-term audience growth and community building. Key Responsibilities - Write high-quality, natural English content - Structure content clearly and logically - Understand relationships between multiple content types - Think strategically about both SEO and user experience - Contribute to a platform designed for long-term membership growth and community building - Organize large-scale content systems effectively - Have knowledge and hands-on experience with Google Ads - Understand how SEO and paid traffic strategies can support overall website growth - Excellent written English proficiency, especially for American audiences - Proven experience in SEO content writing and website content structuring - Strong understanding of SEO best practices, content hierarchy, and internal linking - Experience organizing large-scale content ecosystems (categories, tags, subcategories, page structures, etc.) - Ability to think strategically about both user experience (UX) and SEO - Strong research and content organization skills - Experience writing engaging, natural, and story-driven content - Knowledge and hands-on experience with Google Ads - Understanding of how SEO and paid traffic strategies work together to support website growth - Ability to work independently and contribute strategically in a fast-paced environment - Strong attention to detail and content consistency - Interest or familiarity with travel, van life, camping, outdoor adventures, or lifestyle content is a plus - Experience working with affiliate/content-based websites is a plus Benefits - Competitive salary - Work with fast-scaling, premium brands - Fully remote role with a dynamic, growth-driven team - Clear opportunities for career growth and advancement