Sr. Medical Writer
Horizontal Talent
Job Details
Skills
- Surveillance
- Collaboration
- Regulatory Affairs
- Sales
- Marketing
- Training
- Documentation
- Regulatory Compliance
- Medical Writing
- Pharmaceutical Industry
- Technical Writing
- Writing
- Pharmaceutics
- Clinical Research
- Communication
- Analytical Skill
- Cross-functional Team
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Outlook
- Attention To Detail
- Biomedicine
- Evaluation
- Management
- Quality Assurance
- Risk Management
- Medical Devices
- ISO 13485
- ISO 9000
- Artificial Intelligence
- Job Boards
Summary
Responsibilities
- Develop and refine clinical evaluation deliverables, including Clinical Evaluation Plans, Clinical Evaluation Reports, SSCPs, regulatory responses, and related documentation.
- Review and synthesize evidence from clinical studies, published literature, post-market surveillance, risk documentation, and post-market clinical evaluations.
- Support product applications and submissions by analyzing clinical data and preparing clear, accurate written materials.
- Collaborate with cross-functional partners across regulatory affairs, quality, clinical affairs, engineering, risk management, medical affairs, sales, marketing, and other stakeholder groups.
- Maintain familiarity with assigned products and incorporate relevant information from a wide range of technical and clinical sources.
- Review IFUs, patient materials, training content, risk files, protocols, plans, and reports to help ensure consistency and alignment.
- Contribute to responses to complex questions from external stakeholders and regulatory bodies.
- Ensure documentation quality, accuracy, consistency, and compliance with applicable policies, procedures, regulations, and guidance.
- Bachelor's degree or an equivalent combination of education and work experience.
- 6-8 years of medical writing experience in the medical or pharmaceutical industry, or 8+ years of general technical writing experience.
- Experience writing in a medical, pharmaceutical, medical device, clinical research, or related environment.
- Strong written and verbal communication skills with the ability to explain complex information clearly.
- Excellent analytical skills and the ability to manage multiple priorities and deadlines effectively.
- Comfort working in collaborative, cross-functional team settings.
- Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
- Ability to produce accurate work with strong attention to detail and consistency.
- Background in biomedical science, medicine, or another health-related discipline.
- Prior experience creating Clinical Evaluation Reports and related regulatory documents.
- Familiarity with clinical study design, clinical study management, quality engineering, or risk management.
- Experience working with medical device regulatory requirements and guidance, including ISO 13485, ISO 14155, ISO 14791, MEDDEV 2.7.1, MDR, and FDA/EU guidance.
- Ability to support responses to regulatory inquiries and external questions with sound judgment and professionalism.
Horizontal is committed to fostering an inclusive workplace where diversity, equity, and belonging are valued. We welcome candidates with a wide range of backgrounds, experiences, and perspectives, and we encourage everyone to apply if they meet the core requirements of the role.
By applying for this position, you acknowledge and agree that Horizontal Talent may contact you regarding your application using automated technology, including phone calls, SMS/text messages, or email, which may be delivered by our virtual AI recruiter, Alex.
Please apply through this online posting or by visiting our Job Board at Applications will be accepted for 4 weeks. For those that join the team, we offer competitive compensation and benefits including medical, dental, vision, and retirement. Check out all we have to offer and how you can become part of the Horizontal Talent Team. The pay range for this role is $36 - $70 per hour based on qualifications and experience.
- Dice Id: 10123528
- Position Id: 75907
- Posted 5 days ago
Company Info
About Horizontal Talent
Horizontal Integration offers two service lines. Our staffing agency places IT, digital and creative talent in both contract and permanent roles. Our digital agency provides digital marketing strategy and technology consulting on a project basis. Many of our clients take advantage of both service lines.
We are a certified Minority Business Enterprise, with more than 200 employees across our offices in Minneapolis, Denver, Dallas and Vadodara, India. We ve been consistently growing and profitable since the company was founded in 2003.
Honors:
Recognized as a "2009 Best Place to Work" by Minneapolis/St.Paul Business Journal.
Fact:
Our people and our organization are deeply rooted in IT and interactive marketing.
Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.
In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact us. All applicants applying must be legally authorized to work in the country of employment.
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