at DOCS in Dover, Delaware, United States
Ref #: 29093
Employment type: Permanent – Full-Time
Who We Are:
At DOCS, we care about our people and their passion, as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We have over 4500 employees globally working on novel therapies that deliver real impact to patients in need.
All our team members have the independence to get the job done and support from the experienced leadership team when you need it. If you want a career with a difference, DOCS is the place for you.
1. Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documentation.
2. Contributes to project plan concerning organization and table layout for a specific document.
3. Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented.
4. Review study concepts and edit protocols for consistency, progression, structure, and grammar.
5. Review statistical analysis plans and incorporate into clinical study reports.
6. Drive the document preparation process, receive and review primary statistical output, draft and distribute document for review, and compile comments and edits as necessary.
7. Participate in team and client meetings as requested.
Education and Experience Requirements/Qualifications:
• Advanced degree in a relevant scientific/clinical/regulatory field preferred
• At least 5 years of pharmaceutical industry experience in the clinical/regulatory field
• Global regulatory submission experience.
• 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
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
DOCS is an equal opportunity employer – Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.To view full details and how to apply, please login or create a Job Seeker account