Utilize data model to componentize current templates to convert them to a structured, automation-ready state with data elements that are compatible with Structured Content Authoring software

Manage a team of CMC technical writers and document specialists responsible for the entire end-to-end regulatory process from initial kick-off discussions through submission and response to Health Authority queries. This included managing authoring timelines, subject matter experts (SMEs) and management review cycles, facilitating consensus meetings and data verification. Provided mentorship and training to new and existing document specialists and technical writers.• Onboarded 3 team members, managed and trained 6 CMC technical writers and document specialists responsible for entire end-to-end regulatory submissions process from initial kick-off discussion through submission and response to Health Authority queries.• Authored multiple sections of Module 3 drug substance plasmids, and viral vector for ABECMA® in collaboration with contract manufacturer. • Authored and/or reviewed over 80 cell therapy submissions.• Created (Regulatory Information Management) RIM system training modules and rolled-out to cell therapy cross functional teams with an audience ranging from analysts to Senior Vice Presidents. • Created enhanced data verification procedure using electronic signatures to improve accuracy of regulatory submissions.• Facilitated 6 technical writing workshops for 120 employees to improve technical writing skills.

Manage team of CMC document specialists responsible for the review and approval of clinical and commercial applications along with supplemental and post-approval regulatory submissions. Manage authoring timelines, subject matter experts (SMEs) and technical writer review cycles and formal consensus meetings. Provide mentorship and training to new and existing document specialists and technical writers.• Project lead on CMC initiative to create drug product templates for SMEs to enhance regulatory writing• Collaborate with regulatory team and technical experts to plan detailed submission timelines, outline the filing strategy, and assign project resources• Lead technical writer for several clinical phase submissions, two BLAs, and created template for viral safety dossier• Core team member on technical writing initiative to streamline authoring process between biologics and small molecule writing groups• Led initiative for new electronic data verification process, implemented training and authored SOP• Managed migration of manual data verification documents for regulatory submissions into electronic system• Partner on development of model timelines for commercial submissions and regulatory process training for hCelgene colleagues• Successfully implemented 43 drug substance templates for SMEs • Consolidated Authoring Review and Approval (CARA) Elite team core member• Yellow belt BMS certified, NBR CLIMB leadership and safety committee member

• Managed team of CMC document coordinators/specialists• Core team member on Document Control and Archiving (DCA) project team• Successfully led implementation of a new barcoding system and transition of metadata• Managed support of internal and external technical source document requirements• Facilitated CMC regulatory and technical source documentation needs for Biologics Manufacturing and Process Development• Partnered with Global Regulatory Sciences to create process workflows for authoring and reviewing submission guidelines• Biologics change agent representative for Next Generation Authoring rollout of CARA3 training• Collaborated with quality team to meet regulatory and technical source document requirements during health authority inspections• Successfully managed the transition of third party manufacturing documentation into DCA system

• Facilitated recruiting activities for Biotechnology organization• Responsible for integration process of new employees• Maintained organizational structure for Biotech Development and Operations in HR system• Reconciled employee and contract headcount with Human Resources for Biotech Development and Operations• Provided administrative support for upper level management

Held several positions of increased responsibility during my 14 years with the company. Manufacturer of medical devices for the treatment of respiratory diseases.• Responsible for the set-up, maintenance and distribution of entire sales and marketing budget• Audited weekly expense reports and updated travel budget for sales force• Processed all payroll, bonuses, commissions and expenses for the company• Managed all accounts payable and accounts receivable from initial receipt through payment• Responsible for accuracy of all transactions and on-time payments and receipts along with balancing all month end reports