Holly Andreas
Columbia City,IN
Summary
Highly motivated and reliable Clinical Research professional with over ten years of extensive and hands-on experience in clinical evidence development, data mining, analysis, and medical writing to support regulatory submissions, market access, (reimbursements, tenders, etc.), and market promotional activities. Known for independent problem-solving and on-time delivery of quality results.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Sr. Manager, Evidence Management & PMS
MicroPort
02.2023 - Current
- Leading and supporting PMS, and Medical Writing Teams
- Support the development and creation of Clinical, Scientific, and Regulatory documents in accordance with procedures, European Medical Device Regulation, and US FDA requirements
- Author Clinical Evaluation Reports, Post-Market Surveillance, conducting literature reviews, and collecting and summarize feedback from all sources such as media, salesforce, and competitors’ websites.
- Coordinate all Post-Market Surveillance activities by interfacing with project teams, internal and external personnel, and governmental regulatory agencies
- Responsible for Data Mining, Data Analysis, literature searching and reviews, and Medical Writing to support Regulatory Submission, Post Market Surveillance, Market Access, and Marketing Campaigns globally
- Routinely perform data mining and statistical analysis of a variety of data sources including clinical studies, device registries, and publications
- Perform data compilation and analysis to support implant rating submission (e.g. Orthopedic Data Evaluation Panel in the UK); This rating is being used for procurement and tenders in various markets globally
Manager of Upper Extremity (UE) Medical Writing
Stryker (Wright Medical)
01.2018 - 02.2023
- Leading and supporting UE medical writers/MDR lead
- Manage Tornier Inc. and Tornier SAS product lines (over 50 products)
- Support the development and creation of Clinical, Scientific, and Regulatory documents in accordance with procedures, European Medical Device Regulation, and US FDA requirements
- Author Clinical Evaluation Reports, analysis of product complaints and trends, Post-Market Surveillance, conducting literature reviews, and collecting and summarizing feedback from all sources such as media, salesforce, and competitors’ websites.
- Coordinate all Post-Market Surveillance activities by interfacing with project teams, internal and external personnel, and governmental regulatory agencies
- Responsible for Data Mining, Data Analysis, literature searching and reviews, and Medical Writing to support Regulatory Submission, Post Market Surveillance, Market Access and Marketing Campaigns globally
- Routinely perform data mining and statistical analysis of a variety of data sources including clinical studies, device registries, and publications
- Develop and compose global procedures and templates for medical writing/ post-market surveillance team in accordance with MDR and MEDDEV Rev 4 .
- Perform data compilation and analysis to support implant rating submission (e.g. Orthopedic Data Evaluation Panel in the UK); This rating is being used for procurement and tenders in various markets globally
- Support NB audits (BSI and T
- V)
Clinical Evidence Senior Specialist
Zimmer Biomet (Biomet)
06.2010 - 01.2018
- Responsible for Data Mining, Data Analysis, literature searching, and Medical Writing to support Regulatory Submission, Post Market Surveillance, Market Access, and Marketing Campaigns globally
- Routinely perform data mining and statistical analysis of a variety of data sources including clinical studies, device registries, and publications
- Develop and maintain a global clinical evidence library as the evidence repository for the company’s products and technologies.
- Authored various medical writings including Clinical Evaluation Reports, White Papers, and Clinical Dossiers to support business worldwide
- Perform data compilation to support implant rating submission (e.g. Orthopedic Data Evaluation Panel in the UK); This rating is being used for procurement and tenders in various markets globally
- Perform validations of Clinical Outcomes Score algorithms using SAS or Excel.
- Support and administration of global Electronic Data Capturing systems used for both pre and post-market clinical trials
- Resolve data discrepancies, errors, and omissions with thoroughness and experience
- Drive collaboration with other functional groups and businesses to ensure continuous alignment between business needs and clinical evidence development priorities
- Oversaw and reviewed Biomet studies on clinicaltrials.gov
- Authored work instructions and templates to standardize evidence delivery for market access applications
Environmental Health Specialist
Fort Wayne-Allen County Department of Health
01.2007 - 09.2010
- Investigate foodborne illness during outbreak alerts to determine the cause
- Inspect restaurants and markets routinely to ensure compliance
- Educate employers and schools on food safety during inspections and special presentations per request
- Train new employees
Education
Bachelors of Science - Biology
Purdue University
Fort Wayne, IN12.2006
Skills
- EDC systems
- Computer Programs (SAS, MS office, Access, Excel, Text files
- Medical Writing
- Data analysis
- Literature searches and reviews
- Self-motivated
- Versatile as an individual contributor and team player
- Strong verbal communication
- Conflict resolution
- Good organizational skills
- Team leadership
- Time management
- Complex Problem-solving
- Strategic planning
- Regulatory compliance
- Teamwork and collaboration
- Excellent communication
- Organizational skills
- Problem-solving
- Multitasking
- Negotiation and conflict resolution
- Employee coaching and mentoring
Certification
- SAS Certifications
- Member of American Medical Writers Association
- Praxis I
- NIMS training/courses
- ServSafe certified (now expired)
Timeline
Sr. Manager, Evidence Management & PMS
MicroPort
02.2023 - Current
Manager of Upper Extremity (UE) Medical Writing
Stryker (Wright Medical)
01.2018 - 02.2023
Clinical Evidence Senior Specialist
Zimmer Biomet (Biomet)
06.2010 - 01.2018
Environmental Health Specialist
Fort Wayne-Allen County Department of Health
01.2007 - 09.2010
Bachelors of Science - Biology
Purdue University