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An established industry player is seeking a Senior Medical Writer to join their dynamic team. In this role, you will leverage your clinical knowledge to produce high-quality clinical study documents while collaborating with diverse teams and clients. Your ability to lead projects and mentor junior staff will be crucial as you navigate tight timelines and ensure quality deliverables. This position offers the opportunity to work on a variety of therapeutic areas and make a significant impact in the clinical research field. If you are passionate about medical writing and client satisfaction, this role is perfect for you.
At Parexel you'll team up with some of the best minds in the industry to get new treatments to the patients who need them most. Parexel is one of the largest providers of medical writing services worldwide and has managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. Due to continued customer satisfaction, our team is growing.
We are currently looking for: Home Based Clinical Regulatory Medical Writers in the US and Canada (Full Time & Temporary Roles Available)
As a Parexel Senior Medical Writer, you will be exposed to different project teams, therapies, and devices, as well as a diverse portfolio of clients. The ability to understand our clients' needs and achieve quality results is critical for us to continue being one of the top clinical research organizations (CROs) in the world. To succeed, you must be able to work independently and collaboratively every day.
As a Senior Medical Writer with Parexel, your responsibilities include researching, creating, and editing all documents associated with clinical research. You will be the lead author and primary client contact for medical writing projects, collaborating with other departments and clients to meet internal and external deadlines, leading projects, and training and supporting junior staff.
Our writers are integral to clinical teams supporting our clients worldwide, assisting in writing and coordinating successful documentation across various therapeutic areas.
You will:
Use your clinical knowledge to write and edit clinical study documents
Lead teams to ensure quality and timely deliverables
Partner with sponsors as their primary client contact for medical writing projects
Mentor and train junior medical writing staff
Skills:
Excellent interpersonal, verbal, and written communication skills
Consistently produce high-quality documents
Ability to stay focused under tight timelines
Attention to detail and proactive approach
Understanding of project steps, planning ahead, and identifying critical paths
Flexible attitude towards work assignments and learning; adaptable to change
Efficient time management, prioritizing tasks with attention to detail
Ability to work in a matrix environment, demonstrating leadership and cross-cultural sensitivity
Negotiation skills to align resources, timelines, and expectations
Understanding and satisfying client needs
Building trust and establishing connections beyond individual projects
Knowledge and Experience:
Understanding of clinical research, drug development, industry guidelines, e.g., ICH-GCP
Ability to provide document-specific advice to clients
Scientific background essential
Extensive clinical/scientific writing experience, including study reports, protocols, CTD documents
Advanced MS Office skills, especially Word; familiarity with document management, collaborative tools like SharePoint, and databases like Excel
Fluent in written and spoken English, with good attention to language details
Education:
Bachelor's degree in Life Sciences, Health-Related Sciences, or equivalent
Employment is contingent upon disclosure of your COVID-19 vaccination status and proof of vaccination if applicable.