Colette F Saccomanno, Phd, Mslis Email & Phone Number

United States

Chicago, Illinois, Us

Johnson & Johnson Innovative Medicine Current: Supporting Research & Development Quality Organization to achieve cross-functional integration of a recently-acquired company. Responsibilities include:o Coordinating end-to-end cross-functional team meetingso Ensuring awareness and effective communication (i.e., “connect the dots”)Past: Development of Position Document to support Business Process Change in Product Quality Vigilance. Requires working with Subject Matter Experts to understand current procedure and provide clear explanations and presentation of data to support decisions related to global process changes that will create cross-functional efficiencies and improve regulatory compliance.Past: Support Product Quality Vigilance through separation of Consumer Care Division. Responsibilities included:o Coordinate global and regional cross-functional and cross-company meetings and ensure effective communication (i.e., “connect the dots”)o Develop / edit documentation (e.g., Quality Agreements and ancillary materials, updates to SOPs and Work Instructions, etc.)Past: Support Product Quality Vigilance as part of the deployment of the first Janssen global call center, Janssen Global Vaccine Call Center (JGVCC). Specific responsibilities included:o Coordinating various team meetings including the Adverse Event/Product Quality Complaint Workstream, Steering Committee and the Commercial Quality Global Contact Center meetings (agenda and slide deck preparation, action and risk tracking, meeting notes preparation and distribution)o Supporting the Product Quality Vigilance education and training program by coordinating workstream activity; working with Subject Matter Experts to evaluate, define and design role-specific curricula that include appropriate levels of learning and qualification assessments; working with senior management team to assist in organizing content and preparing for delivery of training and ongoing education.

Most recently engaged as a Scientific Writer to CEPI covering the COVAX Enabling Sciences SWAT Workshop "Global and Local Efforts to Detect and Interpret SARS-CoV-2 Variants" held on October 28 2021. Other selected engagements include providing program management especially relating to global business process and Product Safety and Pharmacovigilance. Clients have included Shionogi, Inc., where I assisted in developing globally-compliant business processes, managed the PSPV team, oversaw major upgrade of the Global Safety Database and provided vendor management, served as cross-functional liaison; reviewed and updated global and regional quality documents to harmonize and modify business processes as needed, and participated in developing inspection readiness culminating in the conduct of a successful (no-findings) FDA inspection of PSPV at year end (2019). Also engaged by Astellas to develop a globally-compliant business process for signal detection and management during clinical development, create training materials for post-marketing pharmacovigilance, and coordinate completion of a peer-reviewed publication (Pharm Med 29(4):197-201).In 2017 I was engaged by the Kentucky Spinal Cord Injury Research Center (KSCIRC) to develop a communications strategy and awareness campaign, re-design the "Victory over Paralysis" website, and build a Social Media Platform. My most significant contribution was launching an apprenticeship program that established a new center for pediatric activity-based physical therapy in NYC.I regularly consult with Landmark Pegasus, Inc,, a corporate strategy consulting firm and provide scientific evaluation ("due diligence"), assist in writing business plans, and develop and deliver investor presentations.

Supporting the executive team through program and project management related to the development of a novel recombinant protein nanoparticle vaccine platform as well as the design and development of corporate presentation materials including the company website, investor presentations, and public relations.

Waltham, Ma, Us

The Industry Director is a strategic role that requires knowledge of supply chain and risk management. Senior-level relationship and account management activities included:• Strategy design, execution and management• Communication of company value proposition and value-added programs• Price management and resource coordination• Request for Proposal (RFP) opportunity identification and coordination of responses

Switzerland 🇨🇭 , Ch

Responsible for working with project teams to develop and implement regulatory-compliant best practices around safety data life cycle management in efficient and effective manners in order to support optimum product benefit-risk profiles. Served as business owner of the Drug Safety Database and worked with Drug Safety Scientists as liaison to IT group in managing performance of database as a workflow management tool.

Responsibilities included company management and product development, re-designing company marketing materials and website, conducting client-specific data-mining research on FDA-AERS database, and developing client support methods and practices. DrugLogic provides project and a proprietary software tools that support global regulatory-compliant pharmacovigilance practices (Q-scan®).

As the most involved member of the Board of Trustees, I decided to "give back" and filled a need created by the retirement of the Library Director of 35-year tenure. Managed and trained a staff of 17 part-time employees, developed policies and procedures, managed building and grounds projects (electric service upgrade, HVAC upgrade, roof repair, cable network), building maintenance, book and material ordering, public relations, outreach and interaction with library users, serving as liaison to the 70+ library Bergen County Cooperative Library System (BCCLS), and managing the Library Information Management System and local cable internet access network. Ultimately earned the Master of Library and Information Sciences degree from Pratt Institute due to state-requirement for Directors of Public Libraries in towns larger than 10,000 population to hold such an advanced degree.

Established and maintained relationships in Bio-Pharma. Primary responsibility was to promote pre-clinical drug development testing services to research and administrative scientists. Required thorough understanding of service offerings and working knowledge of pre-IND (Investigative New Drug) development process in order to assess needs and propose appropriate solutions.

Client base initially consisted of the cytogenetic community involved in basic and clinical research. Entered clinical diagnostics after 510(k)-clearance of several products for hematological oncology. Territory included WV, VA, DC, MD, PA, DE, NJ, NY, CT, MA, VT, NH, ME and Eastern Canada. Managed direct sales and worked with distributor network.

Client base consisted of hospital and reference laboratories with some service to the physicians' office laboratory market.

Ph.D., Cell And Molecular Biology

Mslis, Library And Information Science

Master'S Degree, Library And Information Science

Master'S Degree, Library And Information Science