The primary responsibility of this position includes writing and researching for advisory committee reports and deliver timely news about US regulatory meetings, both for drugs and medical devices contents.
Knowledge on topics related to FDA-regulated products is required.
Responsibilities also include preparation of attendance and attendance to scientific conferences as well as writing related reports.
Researching and writing other documents to enhance the Cortellis is part of the general duties of the position.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsible for researching, reporting, writing articles, and attending FDA advisory committee meetings, workshops, and relevant US medical device regulatory meetings in the Washington DC/Maryland/Virginia Metropolitan area. Reports are to be written, edited, and published by the end of the meeting. The ability to write quickly, succinctly, and independently under tight deadlines is a must. Responsibilities include writing and publishing in Microsoft Word and Adobe Acrobat (PDF). Other duties may be assigned, especially as regards similar writing assignments in the pharmaceutical regulatory area.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Demonstrated ability to independently and succinctly summarize FDA reports and study protocols with minimal assistance (summarize data from clinical studies from FDA submissions).
- The ability to independently research a variety of topics through various online resources (databases, Internet), interviews, and observation.
- The ability to integrate medical, medical device, and regulatory information. A succinct writing style with appropriate self-editing skills.
- Proficiency in standard PC programs a must (Microsoft Word, Outlook, Excel, PowerPoint, and Adobe Acrobat).
- Ability to learn new software applications for publishing a must.
- Must be flexible with work environment. Must be able to work independently in varied environments and at meeting locations throughout the Washington DC/Maryland/Virginia Metropolitan area, and be comfortable in a remote environment.
- Must be able to travel independently throughout the Washington DC/Maryland/Virginia Metropolitan area.
- The ability to thrive under pressure; be highly efficient and independent. Be able to complete tasks on a timely basis with minimal supervision and guidance.
- Demonstrated ability to type and write quickly. Excellent keyboard typing skills are required in order to type summaries of regulatory meetings under extremely tight deadlines
- Excellent command of the English language (written and spoken).
- Good organizational and project management skills.
- Good problem solver and able to demonstrate good judgment in decision making and setting priorities.
EDUCATION and/or EXPERIENCE
- Bachelor’s degree, preferably in journalism.
- Experience in medical writing, the medical device field, regulatory affairs, or related experience will be considered (minimum 2 years).
- Expertise in pharmaceutical/biotechnology drug/biologic/device development is a plus.
It is the policy of Clarivate to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, pregnancy, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Clarivate will provide reasonable accommodations for qualified individuals with disabilities.
To apply for this job please visit bit.ly.