Leah Colvin

About Leah Colvin

20 years of academic and medical writing experience including over 10 years publications experience and 7 years of regulatory writing.• 7+ years of project management, organizational, policy and infrastructure development experience in medical device, pharmaceutical, and academic settings.• Accomplished oral and written communicator who is accustomed to a variety of media including publications, conference and internal presentations, standard operating procedures (SOPs), clinical and preclinical reports, and grants. • Track record of leadership and collaboration including developing constituent networks, working with key opinion leaders (KOLs), supervision, and mentoring.• Bridge builder who creates collaborations and communities via interpersonal connections, common goals, resource curation, needs assessment, negotiation and, if needed, mediation techniques.• Skilled at research and data analysis, including benchmarking, quality control, and communicating results with diverse audiences.

Experience

1. Medical Writing Manager

   Edwards Lifesciences

   Nov 2025 — Present

   Plan, develop and lead the completion of complex medical writing projects in a fast-paced environment with accountability for successful completion within scope of project deliverables including negotiating deliverable timelines, and resolving project-related issues with cross-functional partners (e.g, Regulatory Affairs, Quality, Clinical Project Managers, Clinical Data Management, Biostatistics, etc.)- Act as a technical expert to key stakeholders to develop and lead the implementation of corporate, business unit, and departmental process updates and improvements (e.g, MDR compliance, etc.)- Provide direction and guidance for smaller projects to execute medical writing projects and/or initiatives. Provide mentoring and knowledge transfer for Medical Writing team members- Act as representative in core team meetings in the development of reporting plans and regulatory submissions (US and international) for clinical studies- Lead the identification, recommendation and implementation of continuous process improvements as it relates to medical writing- Author and review: o EU Clinical Evaluation Plans and Reports (CEP, CER, respectively) in compliance with applicable regulations/guidance\'s (e.g, MDD 93/42/EEC as amended by 2007/47/EC, MED DEV 2.7/1, rev 4, MDR 2017/745, MDCG 2020-1, MDCG 2020-5, MDCG 2020-6) o Post market Clinical Follow-up Plans and Reports (e.g, MEDDEV 2.12/2, MDCG 2020-7, MDCG 2020-8), o Summary of Safety and Clinical Performance (MDCG 2019-9), etc.),

Education

• University of Minnesota

  B.A., Biology; Genetics, Cell Biology and Development

  1999 — 2003

• Mayo Clinic Graduate School of Biomedical Sciences

  Ph.D., Biomedical Sciences - Tumor Biology

  2005 — 2011

Skills

• Dna Analysis
• Data Analysis
• English Language Editing
• Technical Writing
• Adobe Illustrator
• Project Management
• Technical Leadership
• Cell Culture
• In Vitro
• 5pmweb
• Career Development Coaching
• Molecular Biology
• Microsoft Office
• Cancer
• Adobe Photoshop
• Fibrosis
• Pcr
• Recombinant Dna Technology
• Career Counseling
• Slack
• Endnote
• Grant Writing
• Leadership
• Adobe Creative Suite
• Protein Analysis
• Drupal
• Science
• Biochemistry
• Life Sciences
• Microsoft Powerpoint
• Cvent
• Cardiorenal Physiology
• Cell Biology
• Manuscript Development
• Dna Extraction
• Protein Expression
• Graphpad Prism
• Event Planning
• Flow Cytometry
• Medical Writing