Editor

Job Title: Editor III

Location: REMOTE

Duration: 24 Months with possibility of extension

Job description:

Work shift (days/times) – 8:15 AM – 4:55 PM ; Mon-Fri

Job Description

Responsibilities: Manages review and approval process for promotional, non-promotional and internal use materials. Manages electronic approval system, user access, user training and workflows. Supports FDA Ad Promo Submissions. Supports QC and regulatory reviews of the materials.

• Coordinate promotional and non-promotional materials review and approval processes

• Maintain in-depth knowledge of approval process routing grids per SOP and route the materials for approvals accordingly

• Perform Quality Check review on the materials prior to routing

• Collaborate with sponsors and agencies to develop and plan PRC meeting agenda

• Facilitate the PRC meeting discussions and document outcome in live meetings while conducting meeting efficiently to cover the full agenda

• Collaborate with marketing operations on prioritization for routine approvals as well as during major campaign launches and label updates.

• Complete regulatory review of promotional and non-promotional materials, final reviews, reapprovals and other review types as necessary

• Develop and update training resources on materials review process and Veeva functionality. Train sponsors, agencies, and reviewers as needed

• Manage user profiles, training needs and access to the VeevaPromomats to sponsors, agencies, and reviewers

• Serve as a point of contact to Veeva vendor for ongoing maintenance and optimization of Veeva workflows. Assist with Veeva Promomats IT validation

• Generate Veeva metric reports to help with process improvement, resource management and compliance monitoring

• Archive OPDP correspondence per guidance from Reg Ad promo lead

• Contribute to development and update of departmental work instructions

• Prepare materials, form 2253, cover letter and send them over to Reg Operations for publishing and OPDP submission

• Support other departmental initiatives as needed (e.g. process improvements)

Years of experience/education and/or certifications required:

•Bachelor’s degree in technical or science related discipline or related work experience

•Preferred: 3 years in Regulatory, Quality or related area

What are the top 3-5 skills requirements should this person have?

• Document-Quality Check
• Good organizational and time management skills
• Strong communication, both oral and written
• Ability to innovate, analyze, understand customers’ needs with minimal supervision
• Proficient with computer systems and/or pharmaceutical software
• Experience in a complex and matrix environment
• Experience in pharmaceutical industry preferred
• Past experience in prescription drug advertising/promotional labeling and/or promotional labeling submissions desired
• Knowledge of procedures and requirements regarding prescription drug advertising and promotional materials desired
• Proficient with computer systems and/or pharmaceutical software
• Science background is a plus

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”