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Mary H. Sims2455 North Talbott Street
Indianapolis IN 46205Cell: 317-340-8813-
Professional ProfileHighly qualified, detail-oriented compliance editor, content developer, and technical writer. with exceptional analytical, critical and strategic thinking skills. Expert-level experience in documentation, regulatory and compliance guidelines, and policy and procedure development within regulated-industry environments, including Pharmaceutical and postsecondary education.
QualificationsWork effectively with legal and regulatory to ensure compliance with internal stakeholders, company policies and guidelines, and U.S. regulatory agencies.
Effectively manage time and resources;Excellent communication, organization, and multi-tasking skills;Experienced working in fast-paced, tight deadline environments
GxP,cGMP, ISO,Sops Comfortable working one-on-one with subject matter experts
Efficient using document management systems Competent using email platforms and social media
Relevant ExperienceManage internal review process in collaboration with legal, regulatory and CEO to ensure compliance with company policies and procedures and government regulatory bodies. Coordinate all marketing creative and recruitment materials for a variety of mediums including print, radio, television, direct marketing emails and collateral pieces. Maintain detailed records of all reviewed and approved documents for audit tracking and KPIs. Write content for multi-channel campaigns include SEOs and SEMs.
Professional ExperienceCompliance Editor, Compliance ITT Educational Services, Carmel Indiana August 2011-present
Responsibilities Serve on a cross-functional review team with regulatory, legal, company CEO and other subject matter experts to review
and approve all internal and external marketing communications, internal policies and guidelines Write and conduct company-wide training related to internal review and approval processes Advise department heads and employees on regulatory guidelines and internal policies and procedures Keep abreast of U.S. Department of Education regulations regarding public facing and student facing publications related
to For- Profit education including website content, print and social media, television
Content Development Specialist, Option Six, a division of General Physics Corporation, Bloomington, IN on contract November 2010 to January 2011.
Responsibilities Serve as primary editor/content developer for cross-functional team to design develop, and deliver customized training
across a broad range of client needs and industries, including healthcare, regulatory, marketing, software, on-boarding, manufacturing, and strategic initiatives
On-demand technical writing, copy editing, proofreading, course content development, media scripting, web-based training, instructor-led training , scenario/case development
Senior Associate Editor, Lilly BioMedicines, Neuroscience Marketing Business Unit, Lilly USA, LLC, Jan 2009 – May 2010
Responsibilities Drive agreement in cross-functional reviews to gain alignment with medical, legal and regulatory, brand management,
project owners, and agencies of record Review and approve sales training materials in coordination with external e-learning development team
Keep detailed records to drive consistency across product indications in compliance with FDA and business unit marketing guidelines.
Provide coaching and training to project owners and agency account executives to ensure standard processes Create, review and approve interactive voice messaging (IVR) content Develop style guide to align with Neuroscience Marketing branding standards and corporate style guidelines
Brand Associate Editor, Neuroscience Marketing, Lilly USA, LLC, Jan 2008 –Dec 2008
Responsibilities
Provide coaching and training to project owners and agency account executives related to Compliance and Regulatory guidelines Drive agreement in cross functional situations and gain alignment across medical, legal and regulatory, brand
management, project owners, and agencies of record Project management of promotional and disease state materials for Direct to Consumer, Direct to Physician, Direct to
Patient, B2B and Web-based marketing Facilitate and manage internal Customer Community Review (CCR) processes Management of internal documentation and storage of clinical data (data on file)
EducationPh.D. in English, Ball State University, Muncie, Indiana, 1999
