Altha Edgren
Consultant at Arrowleaf Medical Writing, LLC
- Role
- Medical Writing Consultant at Arrowleaf Medical Writing Llc
- Location
- Brookline, MA, US
- LinkedIn followers
- 500 followers
About Altha Edgren
Extensive experience and demonstrated competencies in preparation of regulatory, clinical, and marketing documents; publication of electronic and paper submissions to US and global regulatory agencies; development of medical writing staff; and management of cross-functional, collaborative processes and teams.20+ years of experience with collaborative writing and editing contributions to:• Clinical study reports (CSR), investigator brochures (IB), clinical trial applications (CTA) • Common Technical Document (CTD) summary sections• Integrated summaries of efficacy and safety (ISE/ISS)• Investigational Medicinal Product Dossiers (IMPD)• Economic and efficacy dossiers• Peer-reviewed journal manuscripts • Posters, abstracts, slide presentations• Medical encyclopedia entries (searchable online)• Briefing documents, white papers, technical manuals, summary tables, business plans
Experience
Medical Writing Consultant
Aug 2019 — Present
Education
Michigan State University
BS, Nutritional Sciences
1981
Skills
- Medical Writing
- Oncology
- Clinical Research
- Manuscript
- Medical Devices
- Sop
- Abstracts
- Biopharmaceuticals
- Publications
- Clinical Trials
- Clinical Development
- Regulatory Submissions
- Regulatory Affairs
- Fda
- Ectd
- Pharmaceutics
- Ind
- Protocol
- U.s. Food and Drug Administration (Fda)
- Standard Operating Procedure (Sop)
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