Senior Medical Copy Editor
1 day left
- Experience Level
- Experienced (non-manager)
Who are we?
We Are PRA.
We are 18,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
Who Are You?
You are an experience professional with a passion for clinical supplies. You are organized, but flexible and adaptable to unexpected changes. You can easily envision the bigger picture, without losing sight of the day-to-day tasks. You can provide excellent leadership to not only your project teams, but also to clients. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
Still here? Good. Because if this is you, we’d really like to meet you.
What Do I need to Have?
Lead Editors are typically assigned complex projects or other work to support, are expected to perform their responsibilities with considerable independence, coordinate assigned deliverables and guide these across multiple staff members. The Lead Editor will also manage multiple regulatory document projects and be a subject matter expert on document management system processes and procedures pertaining to document creation, review, and approval; responsible for editorial review of documents, checking grammar, style, and usage as defined by company standards; perform quality control (QC) checks of documents against source materials ensuring delivery of accurate and complete work within designated timelines; and responsible for the training, guidance, and mentoring of the editorial junior staff and may oversee vendor deliverables.
Serve as a technical resource
- Expected to manage multiple projects and be a subject matter expert in document management system processes and procedures, which include granular clinical study reports and other regulatory documents; act as a liaison with functional area teams to manage workflows and approve documents.
- Responsible working with and providing oversight vendors maintaining EndNote reference libraries and researching literature references related to regulatory documents.
- Serves as a technical expert for clinical research teams regarding the regulatory EDMS and regulatory publishing requirements
- Independently plans and executes novel and complex assignments
- Assists Regulatory Operations in developing clinical submission project plans.
Ensure accuracy of information
- Has expertise in editing and quality checking to ensure accuracy and consistency within and across documents. Will have functional area responsibility for ensuring that regulatory documents accurately reproduce information contained in source documents and work is completed within designated timelines.
- Using MS Word, the Lead Editor will edit a variety of documents (eg, clinical study reports, Investigator’s Brochures, CTD summary documents, briefing documents). Responsibilities include editing for grammar, style, usage, and consistency with company templates and standards.
- QC review is an added bonus
Lead change and deliver on commitments
- Manage multiple assignments and make effective decisions regarding competing priorities.
- Show solid judgment and independence while interacting with internal team members and external writers or other personnel; communicate well both within and outside Medical Writing about expectations, roles, responsibilities, and technical details.
- Demonstrate a professional approach in adapting to change and be proactive about expressing ideas and concerns in a respectful manner.
Education and Experience:
- Bachelor’s degree in science or biomedical sciences or journalism/English/communications required.
- Computer skills and expertise in relevant applications (eg, Microsoft Office and Adobe Acrobat).
Knowledge, Skills, and Abilities:
- Minimum 5 years of experience in medical editing (preferably pharmaceutical) and expertise with AMA Manual of Style.
- Minimum 3 years writing or editing experience in clinical development environment
- Experience with clinical and regulatory documents, ICH guidelines, and document management systems including experience supporting global original IND/NDA/MAA/ROW filings and management of filing review process in the Americas, Europe and ROW
- Demonstrated ability to manage multiple projects.
- Expert computer knowledge (eg, MS Word, PowerPoint, Excel, and EndNote) and regulatory electronic document management systems (EDMS; eg, Documentum)
- Demonstrates expertise in editing, QCing, formatting, and finalizing clinical, regulatory, and pharmacovigilance documents
- Has an understanding of clinical research processes
- Has an understanding of regulatory processes
- Has in-depth knowledge of other clinical functional areas
- Strong interpersonal skills and ability to work with team members in a variety of roles.
- Excellent organizational and business skills are required.
To qualify, applicants must be legally authorized to work in the UK or European Union, and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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