Regulatory Content Lead Writer
Há 7 horas
At Trilogy Writing & Consulting, we're seeking a highly experienced Regulatory Content Lead Writer to join our team. This is an excellent opportunity for a skilled writer with a strong background in producing high-quality regulatory documents.
About the RoleWe're looking for a seasoned Medical Writer who has expertise in preparing clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures. The ideal candidate will have experience working as the lead writer on multiple projects and have a proven track record of delivering high-quality content within tight deadlines.
In this role, you'll be responsible for managing projects from start to finish, ensuring that all documents meet the required standards and are delivered on time. You'll also oversee a team of writers and QC specialists, providing guidance and support as needed.
Key Responsibilities- Prepare and manage clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures
- Work closely with clients to understand their needs and develop tailored solutions
- Manage project timelines and budgets, ensuring that all deliverables are met within scope and budget
- Oversee and coordinate the work of other writers and QC specialists, providing guidance and support as needed
- Develop and maintain relationships with clients, stakeholders, and internal teams
To succeed in this role, you'll need:
- Relevant professional experience actively writing regulatory documents
- Strong leadership and management skills, with experience overseeing teams of writers and QC specialists
- Excellent communication and interpersonal skills, with the ability to work effectively with clients, stakeholders, and internal teams
- A strong attention to detail and ability to manage multiple projects simultaneously
- A degree in science or a related field, and fluency in English
We offer a competitive salary of €75,000 - €100,000 per year, depending on experience. In addition, you'll receive a comprehensive benefits package, including health insurance, retirement plan, and paid time off. As a remote worker, you'll have the flexibility to work from anywhere in Portugal, and enjoy a work-life balance that suits your needs.
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