Regulatory Technical Author

Job title:

Regulatory Technical Author

Company

Lifelancer

Job description

Job Title: Regulatory Technical AuthorJob Location: Amersham, UKJob Location Type: RemoteJob Contract Type: Full-timeJob Seniority Level:Be part of something altogether life-changing!Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.The Regulatory Technical Author for Cytiva is responsible for writing the documents supporting our regulatory strategyThis position is part of the Regulatory Science & Strategy located in Europe / USA and will be fully remote. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.What you will do:

• Plan, execute and edit documentation related to regulatory, supporting the products through their lifecycle.
• Review and edit Ad Promo documents in the Cytiva document management systems
• Take part in continual improvement workshops related to documentation management
• Be part of cross functional teams to support projects at global level and coordinate documentation between departments including R&D, Operations, Marketing and Quality/Regulatory teams.
• Adhere to the company’s Style Guide, terminology guidelines, and relevant best-practice guidelines

Who you are:

• Experience in quality technical writing in the biotechnology field or related discipline
• Excellent communication, writing, and grammar skills in the English language at the native-speaker level
• Comfortable acting as SME and making decisions on behalf of the team.
• Holds strong commitment to quality and continuous improvement, is willing to act and able to influence others
• Proven problem-solving skills and attention to detail

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel – 15% domestic and international overnight travel within Europe and USA
• Must have a valid driver’s license with an acceptable driving record

It would be a plus if you also possess previous experience in:

• Regulatory compliance aspects of maintaining document conformity, such as the USP RoHS, REACH directives.

At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.For more information, visit www.danaher.com.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.For more details and to find similar roles, please check out the below Lifelancer link.

Expected salary

Location

Amersham, Buckinghamshire

Job date

Sun, 19 Jan 2025 23:54:59 GMT

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