Who are we?
We Are PRA.
- We are 20,000+ 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 Medical Writing.
- 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 will you be doing?
- Researches writes, and edits clinical and regulatory documents by applying functional expertise and clinical drug development knowledge.
- Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents.
- Exhibits excellent written and oral communication and presentation skills.
- Demonstrates technical expertise and background in the use of medical writing templates and software (eg, PleaseReview, Documentum-based platforms, etc.).
What Will You Be Doing?
- Contributes advanced therapeutic expertise, clinical drug development knowledge/skills, and scientific/technical expertise in the development of clinical plan outlines and design of clinical drug development programs for the development of drugs for human use
- Consults with and advises other medical writers and clients in the development of clinical plan outlines and design of clinical drug development programs
- Develops clinical study design documents and clinical protocols
- Builds and maintains strategic relations with customers
- Provides client support regarding clinical data and issues at regulatory meetings
- Directs and/or leads the writing, reviewing and editing of various technical documents
- Evaluates non-clinical and clinical data in the development of technical documents such as regulatory submission documents, (e.g. meeting packages, investigational new drug [INDs] applications, and sections of marketing applications [NDA/MAA/CTD] or other submissions depending on host country), clinical study reports, investigator brochures, pharmacovigilance documents, poster presentations and manuscripts
- Directs or performs scientific literature searches for manuscript writing and to support sections of deliverables including regulatory submissions
- Provides bid estimates for medical writing work for potential projects and attends bid defense when requested
- Leads project teams that involve protocol development and preparation of regulatory information packages
- Serves as project team leader overseeing operational activities of other medical writers
- Develops and implements training for medical writers and mentors junior staff members
- Conducts in-service training for clinical research associates, other clinical functions and clients in area(s) of therapeutic expertise
- Mentors all levels of medical writing personnel
- Develops and implements training for all medical writers
What Do You Need to Have
- Advanced degree in a relevant scientific/clinical/regulatory field preferred
- At least 5 years of experience in a lead oncology medical writing role in the pharmaceutical/CRO industry.
- Excellent writing skills.
- Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
- Knowledge of current requirements and guidelines applicable to submission documents
- Excellent interpersonal and oral communication skills.
- Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
- Ability to prioritize multiple projects
To qualify, applicants must be legally authorized to work in the United States 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.