Project Manager Management

ANN MARIE GOSBEE

Canton, Michigan ***** Cell: 734-***-****

Email: ********@*********.***

Over 10 years of experience within the pharmaceutical/biotech industry, holding various positions in both clinical research and regulatory affairs plus 6+ years in various marketing roles. Recognized by colleagues as a team player that shows initiative, deductive reasoning, self-motivation, and the ability to work with all levels of an organization.

Global Communication: 16+ years of experience interacting with internal colleagues via email and telephone and ensuring successful communication via actively listening and asking probing questions.

Problem solving: Resolution of in-depth queries in a methodical manner independently and with internal and external business partners to find appropriate resolutions that allow for a high level of quality.

Team Player: Sharing knowledge and providing support to cross-functional teams to achieve designated team goals and aligning with company goals.

Planning and organizing: Refining planning and organizational skills that balance work, team support and ad-hoc responsibilities in a timely and professional manner.

Systems knowledge: Knowledge of Global Document Management System (GDMS)/Product Document Management (PDM) in conjunction with MS Office; Salesforce, and Microsoft Dynamics SL.

PROFESSIONAL EXPERIENCE

MMS HOLDINGS, Inc, (Contracted from Kelly Scientific), April 2015 – Jan 2016

Contract Proposal Writer, Proposals and Contracts in Project Management

Worked in conjunction with Project Managers to prepare detailed scoped contracts representing the programming, biostatistics, data management, medical writing and regulatory support deliverable services that MMS Holdings, Inc offered to multitudes of pharmaceutical companies and startups.

Ensured the delivery of quality business proposals and contracts through application of quality checks and incorporation of standardized contract language and costing models

Supported the proposals and contracts team in building commercial proposal packages and executed master service agreements (MSAs), confidential nondisclosure agreements (CDAs), and other contracts

Maintained contract files and records of all contract activity

Managed time logs/labor costs/statuses/timeframe related to all ongoing projects per deliverables

PFIZER GLOBAL RESEARCH AND DEVELOPMENT, (Contracted from i3 Logic), 2010 - 2014

Regulatory CMC – Submissions Operations, Publishing/Document Specialist

Created CMC submission component packages for global filings and manage the submission lifecycle for these in Pfizer’s document management system from initial creation to approval

Performed proofreading/publishing activities for eCTD, non-eCTD dossiers in support of the Pfizer Chemistry, Manufacturing, and Controls (CMC) submission portfolio such as

Biological License Applications, (BLA)

Marketing Authorizing Application (MAA)

Clinical Trial Applications (CTA)

New Drug Applications (NDA)

Investigational Medicinal Product Dossiers (IMPD)

Queries

Investigational New Drug Applications (IND)

which are components of investigational and market registration documents for Food and Drug Administration (FDA)

PROQUEST, Ann Arbor, Michigan, 2008 – 2009

(ProQuest creates specialized information resources and technologies that propel and further enhance successful research and discovery – the products are geared towards the library market)

Assistant Marketing Manager

Developed extensive customer lists (resulting in company savings of $24K in 2008; $48K in 2009) that supported organizational needs and in the creation of marketing collateral, sales support material

BRAND MARKETING

Collaborated with a multi-disciplinary team that developed and implemented marketing programs, plans, and strategies for newly acquired products, Chadwyck-Healy and CSA Online, in a cost-effective and dynamic fashion

PROMOTIONS

Developed and utilizes multiple extensive mailing lists for targeted campaigns through leveraging existing lists, external list sources, and web research to deployed email blasts across various market segments

SALES SUPPORT AND TOOLS

Assisted in updating material for the company web site, product website, and sales newsletters and in the development of other necessary repositories for product and promotional information

MARKET STRATEGIES INTERNATIONAL, Livonia, Michigan, 2007 – 2008

Market Research Associate / Associate Project Manager

Managed all components of multiple market research projects on the Global Life Sciences Team (serving clients – Eli Lily - in the pharmaceuticals industry)

PFIZER GLOBAL RESEARCH AND DEVELOPMENT, (Contracted from i3 Statprobe [Pharma Resourcing division, United Health Group] and Lee’s Temporaries), Ann Arbor, Michigan, 2000 – 2006

Document Specialist / Webmaster

Performed high-quality formatting, editing, proofreading, QC, and publishing activities of scientific and regulatory documents (CSRs, protocols, AEs, CRFs, IBs, SAPs) for FDA submissions for therapeutic areas of cardiovascular, inflammation, infectious diseases, oncology

Clinical Communications Department, (2003 - 2006)

Worldwide Regulatory Affairs Department, (2001- 2003)

Document Administrative Services Department, (2000 - 2001)

EDUCATION AND PROFESSIONAL TRAINING

DAVENPORT UNIVERSITY, Kalamazoo, Michigan

Bachelors of Business Administration in Marketing

Minors in Math, Management, and Social Science

NEW HORIZONS COMPUTER CENTER, Livonia, Michigan

Front Page, 2000 and 2004, and HTML Courses, 2002

COMPUTER SKILLS

Utilized Dreamweaver to create and deploy email blasts through various email channels/capacities

Windows Office 2007 (Microsoft Word • Excel • PowerPoint) • cc:Mail/Outlook • Internet • Google

Databases (DSL • TeamSite • GDMS • DMPS • Documentum • Edocs • Lotus Notes) • INSIGHT • Sharepoint

Webpage (Frontpage 2000 • HTML • Desk Scan • Omnipage) • SPSS • Visio • Livelink • Salesforce

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