$$$
{{ $t($store.state.user.experience_value_in_dollars) }}
Senior
{{ $t($store.state.user.experience_search_name) }}
1
jobs
Medical writer with experience in market access, regulatory and med comms
Sarah Cocklin
,
Durham, United Kingdom
Experience
Skills
I'm offering
• A senior medical writer (member of the European Medical Writers’ Association) with market access, medical communication and regulatory writing experience, including but not limited to:
o Global value dossiers, value messages, payer objection handlers, targeted literature reviews, slide decks, manuscripts, posters, conference summaries.
o Lead author of Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Forms (ICFs), protocols, protocol amendments, review, and Quality Control (QC) of orphan drug applications, New Drug Applications/Marketing Authorisation Applications (NDA/MAA) Modules 2.4, 2.6 and, 2.7.1 and 2.7.2, risk management plans (RMPs).
• Excellent communication skills and ability to work with individuals at all levels.
• Friendly and easy-going but with a strong work ethic.
• Ability to work independently or as part of and/or leading a team.
• Experience in the preparation and review of scientific and market access research posters, grants, manuscripts (both academic and clinical).
• Attention to detail and excellent problem solving and analytical skills.
• Experience dealing with key opinion leaders (KOLs) and trials across a broad range of therapy areas including epilepsy, solid organ transplantation, psychiatry, immunology, oncology, neurodegenerative, infectious, and rare diseases.
o Global value dossiers, value messages, payer objection handlers, targeted literature reviews, slide decks, manuscripts, posters, conference summaries.
o Lead author of Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Forms (ICFs), protocols, protocol amendments, review, and Quality Control (QC) of orphan drug applications, New Drug Applications/Marketing Authorisation Applications (NDA/MAA) Modules 2.4, 2.6 and, 2.7.1 and 2.7.2, risk management plans (RMPs).
• Excellent communication skills and ability to work with individuals at all levels.
• Friendly and easy-going but with a strong work ethic.
• Ability to work independently or as part of and/or leading a team.
• Experience in the preparation and review of scientific and market access research posters, grants, manuscripts (both academic and clinical).
• Attention to detail and excellent problem solving and analytical skills.
• Experience dealing with key opinion leaders (KOLs) and trials across a broad range of therapy areas including epilepsy, solid organ transplantation, psychiatry, immunology, oncology, neurodegenerative, infectious, and rare diseases.
Markets
United States
(Remote
only)
United Kingdom
(Remote
only)
Ireland
(Remote
only)
Rest of Euro area
(Remote
only)
Industries
Ready for
Larger project
Ongoing relation / part-time
Full time contractor
Available
My experience
2021 - ?
freelance
Director/Freelance Medical Writer
Matrix Medical Writing Limited.
• QC of regulatory documents (CSRs, risk management plans [RMPs], protocols, protocol amendments).
• Writing summaries of symposia sessions.
• GVDs
Worldwide Clinical Trials, Nottingham, UK (Home-based)
• Writing summaries of symposia sessions.
• GVDs
Worldwide Clinical Trials, Nottingham, UK (Home-based)
Writing, Risk Management, Management, Medical Writer, Regulatory, QC
2021 - 2021
job
Senior Medical Writer
unknown.
• Lead (limited) and contributing author on regulatory documents including CSRs, protocols, protocol amendments and ICF's to ensure timely, high-quality deliverables in compliance with Standard Operating Procedures (SOPs), Food and Drug Administration (FDA), European Medicines Agency (EMA), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and national and local regulations, as applicable.
• Worked with, and sometimes lead, cross functional teams to develop regulatory documents.
• Medical writing representative on internal task force preparing for the new European Union clinical trial regulation.
• Mentored, supported, and trained other writers.
• Maintained and demonstrated expert knowledge of company- and project-specific guidelines relevant for clinical submissions documents, including SOPs, templates, and document writing conventions and styles.
• Experienced with submission to electronic Trial Master Files (eTMFs).
• Worked with, and sometimes lead, cross functional teams to develop regulatory documents.
• Medical writing representative on internal task force preparing for the new European Union clinical trial regulation.
• Mentored, supported, and trained other writers.
• Maintained and demonstrated expert knowledge of company- and project-specific guidelines relevant for clinical submissions documents, including SOPs, templates, and document writing conventions and styles.
• Experienced with submission to electronic Trial Master Files (eTMFs).
Writing, Administration, Medical Writer, Compliance, Medical writing, Regulatory, International
2017 - 2021
job
Medical Writer (Senior Analyst)
PRMA Consulting Ltd.
• Experienced in writing, reviewing and quality checking global value dossiers, value messages, payer objection handlers, and other value communications documents.
• Experienced in writing and reviewing posters, manuscripts, targeted literature reviews and slide decks.
• Author and presenter of best research poster at International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Europe 2018.
• Experienced project manager delivering projects on time and budget to client specifications.
• Mentored colleagues, developed training materials and delivered training sessions.
• Client facing role, interacting with clients from proposal to project delivery.
• Experienced in writing and reviewing posters, manuscripts, targeted literature reviews and slide decks.
• Author and presenter of best research poster at International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Europe 2018.
• Experienced project manager delivering projects on time and budget to client specifications.
• Mentored colleagues, developed training materials and delivered training sessions.
• Client facing role, interacting with clients from proposal to project delivery.
Project Manager, Writing, Budget, Research, Training, Medical Writer, Poster, Analyst, International, Manager
2016 - 2017
job
Medical Writer
GW Pharmaceuticals Ltd.
• Experienced writing and reviewing Phase 1/2 CSRs, CSR templates, protocol amendments, IBs (clinical and nonclinical), Module 2.7.1 and 2.7.2 and related question based review documents.
• QC of clinical trial associated documents and NDA/MAA modules and responding to quality assurance (QA) audit findings.
• Reviewed clinical trial tables, figures, and listings (TFLs), statistical analysis plans, electronic case report forms (eCRFs) guidelines and TFL shells.
• QC of clinical trial associated documents and NDA/MAA modules and responding to quality assurance (QA) audit findings.
• Reviewed clinical trial tables, figures, and listings (TFLs), statistical analysis plans, electronic case report forms (eCRFs) guidelines and TFL shells.
Writing, Audit, QA, CSR, Medical Writer, Quality Assurance, QC, Audit
2012 - 2015
job
Staff Scientist/Postdoctoral Research Fellow
Beth Israel Deaconess Medical Center.
under the guidance of Dr. Joern Schmitz
• Co-established a National Institutes of Health (NIH) funded core facility which sequenced Fc receptors in over 400 rhesus monkeys to support pre-clinical vaccine trials at 4 research sites for 5 principal investigators.
• Provided 4 research labs with recombinant Fc receptor proteins purified from 22 novel stable cell lines.
• Participated in writing a program project grant (PO1) with 10 principal investigators across 4 research institutions.
• Monthly presentations to the NIH, presented posters at 2 conferences and presented/participated in a scientific advisory board meeting for a Bill and Melinda Gates Foundation funded grant.
• Wrote progress reports for Bill and Melinda Gates Foundation and Duke Center for human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) Vaccine Immunology and Immunogen Discovery (CHAVI-ID) large multi-institutional research grants.
• Retrospective analysis of two pre-clinical studies to determine the role of Fc receptors and Trim5α on viral load, disease progression and vaccine efficacy in simian immunodeficiency virus (SIV)-infected rhesus monkeys.
• Developed and optimised an assay which reduced time to analysis from 2-3 months down to 2 3 days.
• Mentored and trained 4 research assistants.
• Co-established a National Institutes of Health (NIH) funded core facility which sequenced Fc receptors in over 400 rhesus monkeys to support pre-clinical vaccine trials at 4 research sites for 5 principal investigators.
• Provided 4 research labs with recombinant Fc receptor proteins purified from 22 novel stable cell lines.
• Participated in writing a program project grant (PO1) with 10 principal investigators across 4 research institutions.
• Monthly presentations to the NIH, presented posters at 2 conferences and presented/participated in a scientific advisory board meeting for a Bill and Melinda Gates Foundation funded grant.
• Wrote progress reports for Bill and Melinda Gates Foundation and Duke Center for human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) Vaccine Immunology and Immunogen Discovery (CHAVI-ID) large multi-institutional research grants.
• Retrospective analysis of two pre-clinical studies to determine the role of Fc receptors and Trim5α on viral load, disease progression and vaccine efficacy in simian immunodeficiency virus (SIV)-infected rhesus monkeys.
• Developed and optimised an assay which reduced time to analysis from 2-3 months down to 2 3 days.
• Mentored and trained 4 research assistants.
Writing, Research, Support, Advisory board, Health
2011 - 2012
job
Senior Postdoctoral Research Fellow
Drexel University College of Medicine.
under the guidance of Dr. Jane Azizkhan-Clifford and Dr. Simon Cocklin
• Investigated the toxicity of 6 novel anti-HIV compounds against 3 cell lines.
• Investigated the mode of action and efficacy of 4 anti-HIV compounds on viral replication and infectivity.
• Mentored and trained 2 research assistants and 2 graduate students.
• Investigated the toxicity of 6 novel anti-HIV compounds against 3 cell lines.
• Investigated the mode of action and efficacy of 4 anti-HIV compounds on viral replication and infectivity.
• Mentored and trained 2 research assistants and 2 graduate students.
Research, Mode
2009 - 2011
job
Postdoctoral Research Fellow
New York University Langone Medical Center.
under the guidance of Dr. Agueda Rostagno
• Evaluated the toxicity, cytokine production, reactive oxygen species production and metalloprotease release of 6 amyloid beta peptide variants on 3 cell lines.
• Evaluated the effects of 2 drugs on the above outcomes in 2 glial cell lines.
• Evaluated the toxicity, cytokine production, reactive oxygen species production and metalloprotease release of 6 amyloid beta peptide variants on 3 cell lines.
• Evaluated the effects of 2 drugs on the above outcomes in 2 glial cell lines.
Research, Production
My education
2004
-
2008
University of Leeds
Doctorate, Biochemistry
Doctorate, Biochemistry
1998
-
2002
University of Sunderland
1st Class BSc (Hons), Pharmacology
1st Class BSc (Hons), Pharmacology
Sarah's reviews
Sarah has not received any reviews on Worksome.
Contact Sarah Cocklin
Worksome removes the expensive intermediaries and gives you direct contact with relevant talent.
Create a login and get the opportunity to write to Sarah directly in Worksome.
are ready to help you
and get specific bids from skilled talent in Denmark