Ref #: 29093

Employment type: Permanent - Full-Time

Location: US-remote

Posted: 10-May-2021


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.

Principle Responsibilities:
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

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.