Pharmaceutical Regulatory Submissions Specialist
Encompass Communications and Learning, Inc., a renowned and growing company in the life sciences training industry, seeks a highly independent and motivated individual to ensure the accuracy and compliance of life sciences editorial projects. This is a remote position that can begin as either a full- or part-time contract role.
As a member of the submissions group, you will have a key role in ensuring the quality of our training modules and communications examined by our clients’ legal and medical review teams. Working along with our submissions manager, project managers, graphic designers, and editorial groups, you will guide projects from concept to final distribution by navigating the electronic review platforms Veeva Vault PromoMats and ePromo/IQVIA.
You will manage multiple review submissions and deadlines to prepare documents by:
- Performing a quality review of components prepared by our editorial team
- Uploading references into a review platform and searching to avoid duplicates
- Tagging and linking references
- Annotating any relevant comments prior to submission
- Saving comments from the client and communicating with the right internal teams for revision
- Validating changes and preparing documents for the final proof review
Duties and responsibilities
Following a submissions checklist and immersing yourself in the nuances of each client’s needs, standard operating practices (SOPs), and guidelines are of the utmost importance.
The person in this role must:
- Ensure high-quality projects are completed on time
- Review documents prior to submission for accuracy according to the appropriate guidelines
- Act quickly to help turnaround final dispositions promptly
- Communicate effectively with the team, paying attention to internal department delegations and actions needed
- Be technologically savvy and problem solve when issues arise
- Be highly independent and self-motivated
- Be available to work 20 hours a week at a set schedule during normal business hours that you will have say in creating (except during vacations and personal time off)
Skills, experience, and knowledge
- Well-versed in Veeva Vault PromoMats, IQVIA, or other electronic review systems
- Extremely detail-oriented and organized, ability to follow SOPs, standards, and guidelines
- 2+ years relevant work experience, preferably in science, medicine, or pharmaceuticals, or in an advertising agency
- Proficiency in Adobe Acrobat, Microsoft Word, and PowerPoint
- Familiarity with reading marked-up documents and comparing to validate changes
This is a wonderful opportunity for the right candidate. 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 administrative specialist, Candice Poss at firstname.lastname@example.org.
Encompass 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.