1. Mary H. Sims
2455 North Talbott Street
Indianapolis IN 46205
Cell: 317-340-8813-
maryhsims@gmail.com
Professional Profile
Highlyqualified, detail-orientedcomplianceeditor,contentdeveloper,andtechnicalwriter.withexceptional analytical, criticaland
strategicthinking skills. Expert-level experience in documentation, regulatory and compliance guidelines, and policy and procedure
development within regulated-industry environments, including Pharmaceutical and postsecondary education.
Qualifications
Work effectively with legal and regulatory to ensure
compliance with internal stakeholders, company policies and
guidelines, and U.S. regulatory agencies.
Effectivelymanage time and resources;
Excellent communication, organization, and multi-tasking skills;
Experienced workingin fast-paced,tight deadline environments
GxP,cGMP, ISO,Sops Comfortable workingone-on-onewith subject matter experts
Efficient usingdocument managementsystems Competentusingemailplatformsand socialmedia
Relevant Experience
Manageinternal 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 Experience
Compliance Editor, Compliance ITT Educational Services,Carmel IndianaAugust2011-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, INon contract November
2010 to January 2011.
Responsibilities
 Serve as primary editor/content developer for cross-functional teamto design develop, and deliver customized training
across a broad rangeof client needs and industries, including healthcare, regulatory, marketing, software, on-boarding,
manufacturing, and strategicinitiatives
 On-demand technical writing, copy editing, proofreading, course content development, media scripting, web-based
training, instructor-led training , scenario/case development
SeniorAssociate Editor, Lilly BioMedicines, NeuroscienceMarketing 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

2.  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 AssociateEditor, NeuroscienceMarketing, Lilly USA, LLC, Jan 2008 –Dec 2008
Responsibilities
 Provide coaching and training to project owners and agency account executives related to
 Compliance and Regulatoryguidelines
 Drive agreement in cross functional situations and gain alignment across medical, legaland 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 manageinternal Customer Community Review (CCR) processes
 Management of internal documentation and storage of clinical data (data on file)
Education
Ph.D.inEnglish, BallStateUniversity, Muncie, Indiana, 1999