Holly Andreas
Columbia City,IN
Summary
Highly motivated and reliable Clinical Research professional with over fifteen 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. Senior management professional, bringing strategic leadership and operational excellence to drive organizational success. Skilled in project management, team collaboration, and process optimization with keen focus on achieving results. Adept at navigating complex challenges, fostering culture of accountability, and adapting to evolving business needs. Known for strong decision-making, effective communication, and building high-performing teams.
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