- Prepare interactive manuscript templates for projects based on wire frames, flow charts, and existing materials- Collaborate with Strategy, Account, and Design teams in early phases to determine Editorial scope of projects- Act as a writer liaison; answering questions and checking in with writer to ensure smooth and timely delivery of content. Collaborate with assigned writer to produce content that is strategically on-target and incorporate changes as directed from clients and Account team- Maintain an understanding of medical and scientific concepts in order to facilitate the development of manuscripts for both professional and consumer audiences- Work with internal team to optimize content for search engines- Review all content in project deliverables for spelling, grammar, punctuation, consistency, and edit where appropriate- Ensure that AMA style and/or client-approved style is reflected; and manuscript is complete and ready for client review or MLR submission- Ensure references are accurately cited per AMA guidelines and references are properly prepared and annotated for MLR submission- Deliver high-quality manuscripts to Project Manager for submission to client and MLR department- Implement MLR/client changes when appropriate- Determine and communicate risks, milestones, and content progress to Project Manager and team members- Document and monitor the resolution of all content issues

- Drafted, edited, compiled, and obtained internal approval of routine correspondence regarding Regulatory filings, foreign registrations, audits, OFAC and FDA 510k submissions and health ministries - Worked in partnership with manufacturing and QA/QC in designing and enhancing quality management systems to facilitate overall regulatory compliance- Maintained internal and external compliance with audit programs, and managed site inspections by Federal and international Regulatory agencies- Established and maintained policies and procedures to ensure compliance with government regulations and international Good Manufacturing Practice (GMP)- Acted as regulatory liaison for medical or clinical research groups to keep Regulatory Affairs department apprised of research progress- Prepared annual safety reports on approved products, and coordinated reporting of adverse events - Organized, reviewed and coordinated all required technical testing for submissions - Coordinated with testing companies to support submissions

- Conformed to the protocol established by the pharmaceutical company clients when submitting marketing materials for Regulatory review- Closely monitored the progress of each project through various facets of the MLR department's review- Singlehandedly oversaw multiple brands across diverse client base- Developed timelines and delegated responsibilities to appropriate team members for the delivery of the components of the submission- Directed the design and implementation of the components to ensure complete compliance with the client and Digitas Health guidelines- Served as the focal point of contact between the agency and clients' MLR department to gather information on submissions requirements and to answer procedural questions that arose during the review process- Identified the time and efforts needed to efficiently complete each submission; assigned tasks accordingly- Coordinated with the client liaison to ensure timely submission and its conformity with clients’ specifications and expectations- Prepared detailed dashboards of all past, current, and pending submissions, including the stage of review, job codes, and deadlines- Engaged in establishing the Regulatory Review Department; designed, modified, and disseminated procedures to the Razorfish Health Regulatory Review department- Coordinated with other capabilities to develop strategic business associations and help them understand how to work with the organization according to their timelines- Provided support to Razorfish Regulatory counterpart in formulating their process and project organization

- Administered proper submission protocol of the MLR department at the client pharmaceutical company (which consisted of board of experts, including medical doctors, lawyers, and Food and Drug Administration specialists); provided assistance in preparing completed Editorial content for final client review- Supported the Regulatory Review Manager in performing various administrative duties associated with the delivery of the submission- Assumed responsibility in maintaining current files of all final collateral material utilized as reference material for Creative and Account teams- Implemented standards and protocols for MLR submissions as well as version control and processes on all Editorial content- Observed client-mandated procedures for all submissions