Title:
Submissions Specialist
This is a wonderful opportunity for the right candidate. Encompass Communications and Learning, Inc., a renowned and growing company in the life sciences training industry, seeks a highly independent and motivated individual to work in this remote part-time position (20 hours per week) on a 6- to 8-month contract. There is a possibility that the contract will continue past this point or that the position will transition to a permanent 30-hour per week role.
As a member of our submissions team, you will have a key role in ensuring the quality of our educational materials, which are rigorously reviewed by medical, legal, and regulatory (MLR) teams. Working with our submissions manager, project managers, designers, and editorial groups, you will assist in preparing, submitting, and shepherding projects through the regulatory review process.
You will manage multiple submissions and deadlines according to our clients’ review schedules. This effort involves preparing submissions by:
- Performing quality checks of documents prepared by our editorial team
- Uploading sources into a review platform (commonly Veeva Vault)
- Tagging and linking references within the online review platform
- Annotating any comments relevant to reviewers prior to submission
- Routing MLR comments to the appropriate internal teams for revision
- Confirming that our editors properly addressed any requested revisions, and preparing documents for resubmission
Duties and Responsibilities:
You will serve as a gatekeeper to the client’s review team, ensuring a clean submission is received by their review team. Following a checklist and immersing yourself in the nuances of several clients’ needs, standard operating procedures (SOPs), and guidelines is of the utmost importance.
You must be able to:
- Ensure high-quality projects are completed on time
- Review documents prior to submission for accuracy according to the guidelines
- Act quickly when requests are sent to you, whether to initiate a project in the system, respond to a client’s request for revision, or submit a document for initial or follow-up review
- Communicate effectively with our internal team, paying attention to the process for internal department delegations and actions required
- Be technologically savvy and problem solve when issues arise
- Be highly independent and self-motivated
- Be available to work 20 hours a week during normal business hours (except during vacations and personal time off)
- Work without interruption and have a strong and consistent internet connection
Skills, Experience, and Knowledge:
- Extremely detail-oriented and organized, ability to follow SOPs, standards, and guidelines
- Two plus years relevant work experience, preferably in science, medicine, pharmaceuticals, or an advertising agency
- Well versed in Veeva Vault PromoMats, IQVIA or other electronic review system hugely helpful
- Proficiency in Adobe Acrobat for marking up PDFs, Microsoft Word, and PowerPoint
- Familiarity with comparing PDF documents with revisions marked, to revised versions in order to validate changes
If you are interested in this position and believe you are a good fit, please send your resume/CV and letter of interest to our regulatory submissions manager at jspecht@encompasscnl.com.
Encompass Communications and Learning Inc., is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, marital status, age, disability, national origin, citizenship, or any other characteristic.
