Emily Stephens is a high-level professional, who works in Abbott on the position of Freelance Senior Cer Specialist from 2016. This person has earned professional experience in more than 21 positions at different companies. Emily Stephens went to the University of the Sciences In Philadelphia and got education from 2013 to 2015. This professional has such qualifications as Ucla Post-Graduate Professional Writing Program and Ucla. Bothell, Washington is the area, where the professional was lastly known to settle. Emily Stephens's email address and phone number are accessed through SoftwareOfficial on demand.
Name variants:
Emilie Stephens,
Emilia Stephens,
Emely Stephens,
Emilee Stephens,
Emmalee Stephens,
Em Stephens,
Emmy Stephens,
Emmie Stephens,
Millie Stephens,
Milly Stephens,
Ellie Stephens,
Emma Stephens,
Erma Stephens
Last updated May 12, 2024
Contact Information
Last Update
Jul 10, 2022
Email
es**@pharmalinkconsulting.com, me**@gmail.com, es**@gmail.com
Location
Bothell, WA
Company
Workplace
Colleagues
Work History
Freelance Senior Regulatory Writer - 12-Month Contract
1 Waukegan Rd, North Chicago, IL 60064
At AbbVie, we believe the world needs new approaches to addressing today's health issues — from life-threatening illness to chronic conditions. We combine advanced science, expertise and pas...
May 2016 — Mar 2017
Freelance Senior Medical Writer - Cer Specialist - 6 Mos Contract
New Brunswick, NJ
Wrote CER updates for numerous surgical devices sold in Europe on behalf of J&J: Ethicon
Oct 2015 — Apr 2016
Freelance Regulatory Medical Writer - Cer Specialist - 6 Mos Contract
15811 west Collins Ave, Lakewood, CO 80215
Author of multiple CER updates for automated blood processing systems / medical devices sold in Europe.
Sep 2015 — Feb 2016
Freelance Regulatory Medical Writer - 6-Mos Contract
1522 217Th Pl southeast SUITE 100, Bothell, WA 98021
Ad hoc remote contractor who wrote protocols, IBs, and other clinical documents - Created medical posters for conference presentations
Jul 2015 — Dec 2015
Freelance Cmc Regulatory Writer - Multiple 6-Mos Contracts
Ad hoc contract writer and editor for CMC and clinical content of BLAs and INDs
May 2015 — Aug 2016
Freelance Senior Regulatory Medical Writer - Cer Specialist
710 Medtronic Pkwy, Minneapolis, MN 55432
Ad hoc writer of CERs and CER updates for medical devices (e.g., bone mill, intraoperative surgical nerve indicators, etc.) used in Europe
Mar 2015 — Jun 2015
Freelance Senior Medical Writer - 1-Mon Contract
20 New England Ave, Piscataway, NJ 08854
Short-term contract with bi-weekly onsite responsibilities for a biosimilar company in Chicago: - Wrote a peer-reviewed journal article intended for publication regarding PK/PD results and c...
Mar 2015 — Apr 2015
Official Medical Writing and Translation Company For Isct
Ad hoc remote contractor:
“Road Map for Planning Cell Product Manufacturing to Optimize COGs” article to be published in Cytotherapy 2016.
Co-writer/editor on behalf of ISCT President Mas...
Jan 2015 — Feb 2016
Freelance Cmc Regulatory Writer - 4-Mos Contract
1 Amgen Center Dr, Thousand Oaks, CA 91320
Short-term remote contractor responsible for writing ICH CTD Module 3 S.2.6 in-house templates for monoclonal antibody products
Nov 2014 — Feb 2015
Freelance Medical Writer
1616 Eastlake Ave east SUITE 201, Seattle, WA 98102
Remote contractor:
Ghost writing the CEO’s book “Nipple Aspirate Fluid Exfoliative Cytopathology and Molecular Biomarkers: Current Role in the Management of Breast Health”
Responsible for...
Oct 2014 — Feb 2016
Freelance Medical Writer - 5-Mos Contract
Remote contractor: - Wrote published articles based on international SME scientist’s slide decks or posters. Articles were focused on manufacturing, process controls, quality controls, and d...
Sep 2014 — Jan 2015
Founder and Chief Executive Officer
27721 105Th Ave southeast, Kent, WA 98030
from 2014
Freelance Regulatory Medical Writer - 8-Mos Contract
Translated clinical study endpoints into outcome measures from a backlog of CSRs, protocols, final reports, statistical analysis plans, data tables, and listings to populate the www.clinical...
Nov 2013 — Jun 2014
Freelance Regulatory Medical Writer and Cmc Content Writer
400 Dexter Ave north, Seattle, WA 98109
Apr 2013 — Mar 2015
Perm Regulatory Medical Writer
1100 Fairview Ave north, Seattle, WA 98109
Write eCTD-compliant FDA/CDER and CBER regulatory submissions: pre-IND, IND/IDE submissions, amendments, and annual reports
Drug Master File (DMF), clinical protocols, informed consent for...
Feb 2011 — Apr 2015
Perm Regulatory Medical Writer
134 Turnpike Rd SUITE 200, Southborough, MA 01772
Independently analyzed and interpreted complex clinical laboratory values, hematological measures, and vital sign results from efficacy and safety data listings, tables, and figures; reporte...
Jan 2009 — Sep 2009
Associate Scientist and Managing Technical Editor
Compiled/wrote/edited/published multiple concurrent Final Test Reports for the DTRA. Process included analyzing and comparing scientific documents and corresponding data from several contra...
Aug 2007 — Feb 2009
Technical Writer
2400 west Empire Ave, Burbank, CA 91504
Wrote training documents and SOPs for proprietary software user manuals within the closed-captioning department
Sep 2002 — Sep 2005
Education
2013 — 2015
1996 — 2002
Occupations
Executive
Chief Executive Officer
Founder
Scientist
Biotechnology Professional
Writer
Corporate Executive
Chief Executive
Founding Member
Biologist
Biological Scientist
Skills
Pharmaceutical Industry
Oncology
Biotechnology
Regulatory Affairs
Clinical Trials
Regulatory Submissions
Medical Writing
Validation
Fda
Sop
Gmp
Pharmaceutics
Glp
Technology Transfer
Pharmacovigilance
Good Clinical Practice