Experience

Vericel Corporation

• United States
• Biotechnology Research
• 200 - 300 Employee

• Manager of Regulatory Operations

  • Feb 2020 - Present

  Oversee daily regulatory information management (RIM) and submission activities for the organization. Using an advanced RIM system, manage all content for various regulatory application types. Liaise with our submission vendor to ensure timely execution of planned and ad hoc submissions. Collaborate with partner organizations on major submissions Vericel is not entirely responsible. Assist with various information management system activities including testing, technical support, change control, implementations, and related activities within and adjacent to regulatory systems.



Cyclerion

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Associate, Regulatory Operations

  • Apr 2019 - Dec 2019

  Principle Reg Ops Associate on cross-functional teams that managed the global clinical and commercial dossiers for achalasia, cardiovascular disorders, and sickle cell products. Executed the development and implementation of systems and procedures used to support regulatory submission activities, recently transitioned EDMS from Veeva Vault to Montrium Connect. Experienced with eCTD production, document publishing and management. Principle Reg Ops Associate on cross-functional teams that managed the global clinical and commercial dossiers for achalasia, cardiovascular disorders, and sickle cell products. Executed the development and implementation of systems and procedures used to support regulatory submission activities, recently transitioned EDMS from Veeva Vault to Montrium Connect. Experienced with eCTD production, document publishing and management.



Ironwood Pharmaceuticals

• United States
• Biotechnology Research
• 200 - 300 Employee

• Senior Associate, Regulatory Operations

  • Oct 2017 - Mar 2019

  Reported to the Associate Director, Regulatory Operations, assisted with the development and implementation of systems and procedures used to support regulatory submission activities including eCTD production, document publishing, and document management. Responsible for participating in day-to-day Regulatory Operation publishing activities in support of the company’s goals. Reported to the Associate Director, Regulatory Operations, assisted with the development and implementation of systems and procedures used to support regulatory submission activities including eCTD production, document publishing, and document management. Responsible for participating in day-to-day Regulatory Operation publishing activities in support of the company’s goals.



PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• Senior Specialist, Global Regulatory Operations

  • May 2017 - Sep 2017

  Completed transition of projects from ARIAD Pharmaceuticals to Takeda Pharmaceuticals after being acquired in February, 2017. Completed transition of projects from ARIAD Pharmaceuticals to Takeda Pharmaceuticals after being acquired in February, 2017.



ARIAD Pharmaceuticals, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Specialist, Global Regulatory Information and eDocumentation (GRID)

  • Oct 2016 - May 2017

  Senior Specialist providing R&D electronic document management coordination & services (templates, formatting, proof-reading, publishing, and archiving) for R&D regulatory documents by supporting the business implementation and life cycle management of electronic document management systems (EDMS) and associated business processes. Execute and maintains processes for Regulatory Affair’s global submissions, correspondences, and commitments in accordance with Good Documentation Practices. • Contributed to a successful NDA submission, August 2016. • Completed over 200 submissions (Annual Reports, Canadian, IMPDs, Info Amendments, Investigator Qualifications, Protocol Amendments and over 300 Safety submissions.) • Updated and wrote a more efficient “GRID Safety Submission Process” and “GRID Investigator Qualifications Process” for the ARIAD Operation Manual. • Trained colleagues how to publish both Investigator Qualification and Safety submissions.



BioBridges

• Business Consulting and Services
• 1 - 100 Employee

• Regulatory Operations Specialist, Consultant at ARIAD Pharmaceuticals, Inc.

  • Jun 2015 - Sep 2016

  Knowledgeable in the areas of Regulatory Operations, e.g.: finalizing submissions, editing/formatting/ publishing documents, and software applications (ARIM & FirstDoc) for managing regulatory files. • Maintain and administer the global regulatory information and documentation databases • Electronically publish regulatory submission documents to industry and company defined standards (INDs, NDAs, CTA, MAA, eCTD, NeES, etc.) • Electronically publish regulatory submissions using the eCTD software suite to industry and company defined standards • Adhere to assigned timelines for global regulatory submissions • Supports Medical Writing in the tracking, preparation, and finalization of Clinical Study Reports within the enterprise document management system, and liaison with Clinical Quality • Assurance (CQA) to process the Clinical Study Reports through the CQA approval process • Serve as a primary user and business expert of the eCTD software suite • Provide business user support for the workflow of regulatory submission documents through the document management system • Execute assigned activities for eCTD life-cycle document management within the document management system and the eCTD software suite • Execute, adhere to, and recommend improvements to Regulatory Operations work practices and guidelines • Execute Regulatory Operation’s quality assurance processes on electronic submission documents and the validation processes for eCTD submissions as directed • Maintain the eCTD word processing templates and train users on their functionality • Maintain the eCTD viewing system docbase archives/regulatory submission archives • Execute computer system validation test scripts as directed



eMusic

• United States
• Musicians
• 1 - 100 Employee

• Senior Director of Creative Services

  • Jun 2007 - Nov 2008

  • Established design team of six that consistently delivered exceptionally compelling creative solutions including branding, print, packaging, web presence, and direct marketing. • Led daily operations of Creative Services Department. • Reported directly to CEO. • Established design team of six that consistently delivered exceptionally compelling creative solutions including branding, print, packaging, web presence, and direct marketing. • Led daily operations of Creative Services Department. • Reported directly to CEO.



Condé Nast Publications

• Software Development
• 1 - 100 Employee

• Creative Marketing Director, New Business Development

  • Oct 2006 - May 2007

  Strategic development and execution of subscription acquisition marketing programs for Condé Nast’s 28 magazines. Strategic development and execution of subscription acquisition marketing programs for Condé Nast’s 28 magazines.



Bon Appetit

• United States
• Professional Training and Coaching

• Design Director, Bon Appétit Magazine

  • Jan 2003 - Mar 2006

  • Promoted within six months from Production Coordinator to Design Director. • Managed promotional art department of nine. • Projects included advertorials, special events, print collateral, and promotional website. • Promoted within six months from Production Coordinator to Design Director. • Managed promotional art department of nine. • Projects included advertorials, special events, print collateral, and promotional website.



Goldman Sachs

• United States
• Financial Services
• 700 & Above Employee

• Web Manager and Technology Communications Specialist

  • Mar 2001 - Oct 2002

  • Led team to strategize and implement Technology Division website redesign. • Designed PowerPoint presentations for CEO and Head of Technology. • Created Technology Division handbooks on Career Development, Managing Employees & Communications. • Increased employee awareness of policies and procedures. • Produced monthly global e-newsletter, Plug Into Technology. • Led team to strategize and implement Technology Division website redesign. • Designed PowerPoint presentations for CEO and Head of Technology. • Created Technology Division handbooks on Career Development, Managing Employees & Communications. • Increased employee awareness of policies and procedures. • Produced monthly global e-newsletter, Plug Into Technology.


State Street Corporation
• India
• Appliances, Electrical, and Electronics Manufacturing
• 1 - 100 Employee
• Creative Director & Senior Communications Officer

  • Sep 1995 - Feb 2001