CONSUELO BERNAL

Address: **** ***** ***. ********, ** 91306

Cell Phone: 818-***-****

Email: ad4bfg@r.postjobfree.com

hGps://linkedin.com/in/consuelo-bernal

Highly mo*vated and experienced in customer services with a strong background in managing complex projects, analyzing and interpre*ng systems, laws and regula*ons, and providing excep*onal services to diverse stakeholders. I am commi?ed to upholding the integrity of the organiza*on as results-driven professional. I assume with loyalty challenges and task assign to me and to the team. I adept at data migra*on for M&A focus on records and informa*on management. Seeking to leverage my experience and skills to a posi*ve contribu*on to the organiza*on.

SKILLS

Project management, MS Office, Management Informa*on Systems, Data Collec*on, Record keeping, cybersecurity, administra*ve skills, customer service, *me management, reliable, crea*ve, troubleshoo*ng, resourcefulness, work ethic, strategic planning, posi*ve aLtude. Knowledge of FDA and other interna*onal regulatory agencies, RIMS, EDMS, eCTD, Veeva Vault, File Trail, ServiceNow, Oracle, AI, MicrosoS Windows, etc.

WORK EXPERIENCE

Sr. Associate GRASS AMGEN, Thousand Oaks, CA 04/2004 – 12/2013

• Led the intellectual property project achieving the standardiza*on of Amgen’s laboratory notebook process across sites globally with new acquisi*ons.

• Arranged notebook area and implemented a new system to provide a be?er customer service to scien*sts, management, and the legal department.

• Collaborated with cross-func*onal teams to protect Amgen’s intellectual property and provide be?er assistance during regulatory inspec*ons maintaining system accuracy and availability. Regulatory Informa7on Management Systems Baxalta – Shire, Westlake Village, CA 05/2014 – 12/2017 CONSUELO BERNAL

• Spearheaded a gap analysis between the RA System against paper records, resul*ng in Baxter legacy documents for biological products available and electronic records organized into the eCTD dossier.

• Managed a Global RA Project, leading to 95% results to compile in one place the global informa*on of the physical and electronic records storage loca*on as due diligence during a disaster recovery.

• Provided support for acquisi*ons and dives*tures with data migra*on and verifica*on.

• Fulfilled ServiceNow request across func*ons and sites globally. Regulatory Affairs Informa7on Management AVEO Oncology, Cambridge, MA 03/2018 – 01/2019 Remote – Temporary Project for AVEO

• In collabora*on with func*onal area managers, organized and prepared drug development informa*on for migra*on into a new system.

• Searched archived NDA submission documents and created spreadsheets for all products. Background Inves7gator PERATON, Loveland, CO 05/2019 – 12/2013

• Department of Defense – Top secret clearance

Scheduler Dynamic Nursing, Sherman Oaks, CA 08/2022 – 12/2022 File Clerk SCIOLEX, Los Angles, CA 06/2023 – 02/2024

• US Ci*zenship and Immigra*on Services – Top secret clearance EDUCATION AND TRAINING

Bachelor of Science in Interna7onal Business Management University of Phoenix, Woodland Hills, CA GPA 3.85 Gradua*on 06/2012.

Mastery of Business Fundamentals Loyola Marymount University Online cGMP: Document – Record Keeping and ICH – GCP Biopharma Ins*tute Online Course Cer7ficate in Drug Regulatory Affairs UDEMY Online Cybersecurity Course IBM – Coursera Online