Helen Baldwin

Director of Scinopsis

Native English, fluent in French

PhD in Pharmacology (1988)
BSc in Pharmacology (1985)

EMWA President (2009-2010)
EMWA Vice President (2007-2009)
EMWA workshop leader (2005-date)

Helen created Scinopsis in 2006. She started medical writing in 1999 and has a great deal of experience in all types of regulatory documents and medical communications.

PREVIOUS EXPERIENCE

Medical Writer (1999-2006)
Freelance, France

Clinical Project Manager (1994-1999)
FDM Pharma, France

Senior Research Scientist (1990-1993)
Astra Neuroscience Research Centre, UK
Post-Doctoral Research Scientist (1989-1990)
Department of Neuropharmacology,
Scripp’s Clinic, USA

Helen has 31 publications
from her research career

Hélène Sardet

Business and Project Manager

Native French, fluent in English

Doctor of Pharmacy (PharmD) (2003)
MSc in Clinical trials and Marketing (2002)

Hélène joined Scinopsis in April 2013. Hélène has worked in clinical development since 2003 and has an excellent understanding of the pharmaceutical industry having worked for pharma and biotech companies of varying size and structure.

PREVIOUS EXPERIENCE

Clinical Project Manager (2011-2012)
Galderma, France

Clinical Project Manager (2007-2010)
NicOx S.A, France

Clinical Research Associate (2003-2007)
Sanofi Aventis, France

Hélène has managed international Phase I-IV clinical trials in cardiology, central nervous system, rheumatology, dermatology and aesthetic areas.

Céline Masson

Business and Project Manager

Native French, intermediate in English

MSc in Veterinary Pharmacotechnics (2003)
MSc in Animal Physiology (2002)

Céline joined Scinopsis in September 2013. Céline has worked in clinical research since 2004 and has an excellent understanding of the pharmaceutical industry having worked for pharma and biotech companies of varying size and structure.

PREVIOUS EXPERIENCE

Clinical Project Manager (2010-2012)
Umanis, full time contract at Galderma, France

Clinical Project Leader (2009-2010)
Naturalpha, France

Clinical Research Coordinator (2004-2008)
Mediscis, France

Céline has managed international Phase I-III clinical trials in neurology, diabetology, nephrology, infectious diseases, cardiology, immunology, dermatology, orphan diseases and nutrition. Céline was involved in setting up a Phase I nutrition research unit and participated in the development of their quality system.

Julia Croizier

Business and Project Manager

Native French, Intermediate in English

University Degree of “Quality Auditor in Healthcare Industries” (2013)
Bachelor degree in Science (1990)

Julia has worked in health care industries since 1993, in clinical development, safety, quality and data management. She has a thorough knowledge of the pharmaceutical and the medical device industry environment. She has worked both on the sponsor and the CRO sides.

Julia joined Scinopsis in December 2017.

PREVIOUS EXPERIENCE

Clinical Project Manager (2015-2017)
Iris Pharma, La Gaude, France

Quality Auditor and Safety Manager (2012–2014)
GCP Inspection Readiness Project Manager (2009-2012)
Clinical Project Manager (2006-2009)
Nicox, Sophia Antipolis, France

Data Optimisation Manager (2001-2006)
Coordinator Secondary Monitoring (1999-2000)
Allergan, Sophia Antipolis, France

Study Site Coordinator (1999)
Synthelabo Hôpital Pasteur, Nice, France

Clinical Research Associate (1997-1999)
Central Clinical Trial Coordinator (1993-1997)
FDM Pharma/Valorum, Sophia Antipolis, France

Quality Manager (1990-1993)
Picard, Andrézieux, France

Julia has managed international Phase I-III clinical trials in ophthalmology, rheumatology, cardio-metabolic diseases, orthopaedics, urology, and dermatology areas.

Kristina Corpet

Finance Manager

Trilingual in English, French and German

Degree in Hotel business

Kristina joined Scinopsis in March 2010 and is responsible for the overall management of Scinopsis' finances and administration.

PREVIOUS EXPERIENCE

Manager of reception and finance (2007-2009)
Pierre & Vacances, France

Export manager (1997-2001)
Câbles Industriels de Champagne, France

Management assistant (1994-1996)
Hertz France SA, France

Assistant Service Groupe (1992 -1993)
Compass Tours Incoming, Germany

Commercial assistant (1991-1992)
PCSL Software, Germany

Reservation assistant (1990 -1991)
HRS, Hotel Reservation Service, Germany

Marianne Bonin

Quality, Environment, Health and Safety Manager

Native French, fluent in English

BA in Commercial English and Spanish (1985)

Marianne joined Scinopsis in October 2017. She has worked in quality management, clinical research, pharmaceutical sciences and medical devices since 1996. Before joining Scinopsis, she spent 3 years as a consultant in quality management, implementing and maintaining quality systems in various types of companies. She also performed audits, training and coaching in the fields of quality, and health and safety.

PREVIOUS EXPERIENCE

MABC, France
Quality Management Consultant (2015-2017)

Nicox, France
Quality Records Manager (2010-2014)
R&D Training Manager (2010)
Quality Assurance Specialist for CMC and Clinical Trial Supplies Manager (2006-2010)

Allergan, France
Investigational Supplies Coordinator (2006)
Quality Systems Administrator and Good Practices/Quality Trainer (2000-2005)
Quality Assurance Assistant (1998-1999)

Pharmalysis, France
Investigational Supplies Production Manager (1996-1997)

Freelance, France
Manager of a theatre company, Actress, Stage Director (1985-1996)

Charlotte Cunningham

UK Office Manager

Native English speaker

BSc (Hons) Environmental Protection (1999)

Charlotte joined Scinopsis in September 2016 and is responsible for the overall management of the UK office.

PREVIOUS EXPERIENCE

Project Manager and Patient Information Leaflet User Testing (PILUT) Manager (2013-2016)
Spectrum Regulatory Solutions, Horsham, UK

Project Coordinator (2011-2013)
Spectrum Regulatory Solutions, Horsham, UK

Sales/Office Administrator (2008-2011)
Networks Unlimited, Pulborough, UK

Helpdesk Coordinator (2001-2008)
Sykes & Son Ltd, London, UK

Charlotte has over 15 years’ administration experience within several very diverse industries.

Sarah Hopwood

Principal Medical Writer

Native English, fluent in French

PhD in Neuropharmacology (2000)
BSc (first class honours) in Pharmacology (1996)

Currently enrolled in the EMWA
advanced professional development programme in medical writing.

Sarah joined Scinopsis in September 2009 after working as a medical writer in an international medical communications agency for 3 years. She is very experienced at writing a wide range of regulatory documents and medical communications covering many therapeutic areas. She has experience of managing complex medical writing projects with multiple medical writers.

PREVIOUS EXPERIENCE

Medical Writer (2006-2009)
Envision Pharma, UK

Post-Doctoral Research Associate (2003-2006)
Department of Anaesthetics, Pain Medicine
and Intensive Care, Imperial College London, UK

Post-Doctoral Research Associate (2001-2003)
Department of Clinical Neurosciences
and Chemistry, King’s College London, UK

Sarah’s research experience includes
depression, anaesthetics, stroke therapy
and neurotrauma. She has 15 full publications
from her research career.

Gaële Ducher

Principal Medical Writer

Bilingual in English and French

PhD in Physiology (2005)
MSc in Physiology (2000)
BSc (Hons) in Sport Sciences (1999)

Currently enrolled in the advanced EMWA professional development programme in medical writing

Gaële joined Scinopsis in November 2011 and is experienced at writing a wide range of regulatory documents and medical communications covering many therapeutic areas.

PREVIOUS EXPERIENCE

Research Associate (2010-2011)
Department of Kinesiology, Penn State University, USA

Post-doctoral research fellow (2006-2009)
Centre for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, Australia

Fellowship researcher (2003-2005)
Inserm ERIT-M0101, France

Gaële has extensive research experience in rheumatology, paediatrics, medical imaging and sport sciences.

Gaële has 25 publications from her research career. She has served as a reviewer for several peer-reviewed journals and as an expert for research organisations and universities.

Magali Le Goff

Principal Medical Writer

Bilingual in English and French

PhD in Biochemistry/Ophthalmology (2002)
MSc in Biotechnology (1998)
Engineer in Chemistry/Biochemistry (1998)

EMWA Foundation Certificate in Medical Writing (2012)
Currently enrolled in the EMWA advanced professional development programme in medical writing.

Magali joined Scinopsis in February 2012 and is experienced at writing a wide range of regulatory documents and medical communications covering many therapeutic areas.

PREVIOUS EXPERIENCE

Research Associate (2009-2012)
Faculty of Medical and Human Sciences, University of Manchester, UK

Research Associate (2002-2009)
Wellcome Trust Centre for Cell-Matrix Research, Faculty of Life Sciences, University of Manchester, UK

Magali has extensive research experience in ophthalmology, oncology, biochemistry and biotechnology and has published 10 articles from her own research and 2 reviews in ophthalmology. Magali has served as a reviewer for peer-reviewed journals including Investigative Ophthalmology & Visual Science and Journal of Biological Chemistry.

Hannah Bartrum

Senior Medical Writer

Native English, intermediate in French

PhD in Organic Chemistry (2009)
MSci in Chemistry (2005)
MA Natural Sciences (2004)

Currently enrolled in the EMWA professional development programme in medical writing.

Hannah joined Scinopsis in September 2014.

PREVIOUS EXPERIENCE

Marie Curie Intra-European Fellowship (2012-2014)
Université Joseph-Fourier, France.

Postdoctoral Research Associate (2009-2012)
Department of Organic Chemistry, University of Nottingham, UK in a collaborative project with Pfizer, Sandwich, UK.
Hannah has been involved in writing journal articles containing her research results, which have been published in several peer-reviewed journals.

Séverine Waterdrinker

Senior Medical Writer

Bilingual in English and French

MSc in International Drug Development and Registration (2003)

MSc in Pharmacology (1999)

Currently enrolled in the EMWA professional development programme in medical writing.

Séverine joined Scinopsis in September 2014 after 15 years in Regulatory Affairs and Clinical Quality in the pharmaceutical industry. She has an extensive experience in CTD dossier preparation in many therapeutic areas.

PREVIOUS EXPERIENCE

Global Regulatory Affairs (2009-2014)
Novartis, Switzerland.

European Regulatory Affairs (2002-2009)
Allergan, France.

Clinical Quality (1999-2002)
Allergan, France.

EU Clinical Trials Directive Trainer (2005-2010)
CEFIRA, France.

Kathryn Hall

Senior Medical Writer

Native English

PhD in Molecular Virology (2010)
BSc in Microbiology with Immunology (2004)

Kathryn joined Scinopsis in November 2015 after 2 years working for a medical communications agency.

PREVIOUS EXPERIENCE

Medical Writer (2013-2015)
Oxford PharmaGenesis, UK

Postdoctoral Research Fellow (2009-2013)
University of Leeds, UK

Kathryn has medical writing experience in cardiovascular medicine and has published her own research in oncology and virology in peer-reviewed journals.

Dominique Helberg

Senior Medical Writer

Native English speaker

MSc in Clinical Nutrition (2013)
BSc (Hons) Human physiology & Chemistry (2011)

Dominique joined Scinopsis in August 2016 after 2 years of medical writing. She is experienced at writing regulatory documents and medical communications in a number of therapeutic areas.

PREVIOUS EXPERIENCE

Medical Writer (2014-2016)
Spectrum Regulatory Solutions, Horsham, UK

Practice Manager (2011-2013)
W1 Dental, London, UK

Dominique has medical writing experience in oncology, analgesics, antimuscarinics, dentistry, mental health and nutrition.

Sue Tollerfield

Senior Medical Writer

Native English, intermediate German

PhD in Chemistry (1989)
BSc (Hons) in Chemistry (1985)

Sue joined Scinopsis in November 2017. She has over 16 years’ experience of medical writing in the pharmaceutical industry.

PREVIOUS EXPERIENCE

Head of Clinical Study Management, Clinical Team Lead, Principal Clinical Project Manager (1999-2007)
International Study Manager, Clinical Project Manager (1995-1999)
Clinical Project Co-ordinator, Clinical Research Associate (1991-1995)
Schering Health Care Ltd, UK

Science Editor (1989-1991)
British Industrial Biological Research Association, UK

Sue has clinical development experience in a range of therapeutic areas including oncology (leukaemia and lymphoma, breast cancer, colorectal cancer and transplantation), X-ray, ultrasound and MRI contrast media, and hormone replacement therapy (pill and patch). Sue’s medical writing experience covers protocols and amendments, patient information leaflets and informed consent forms, clinical study reports, investigator brochure and PSUR updates, responses to regulatory authorities’ questions, integrated efficacy and safety summaries, and manuscript, abstract and slide set preparation.

Sue’s PhD research involved the synthesis and biological evaluation of some phosphate triester derivatives of the antiviral drug ara-A.

Sue has 10 full publications from her PhD research and from pharmaceutical industry clinical development studies.

James Kistler

Medical Writer

Native English, conversational French

PhD in Microbiology (2014)
BSc in Medical Microbiology (2005)

James joined Scinopsis in January 2016 after 2 years working as a postdoctoral researcher in oral microbiology.

PREVIOUS EXPERIENCE

Postdoctoral Research Assistant (2014-2016)
Queen Mary University of London, UK

Molecular Biologist (2006-2010)
The Doctors Laboratory, UK

Medical Technical Officer (2005-2006)
Health Protection Agency, UK

James’ research has included the use of molecular methods to characterise the composition of the human oral microbiome in health and disease, and the evaluation of novel oral hygiene products.

James has published articles from his research career in several peer-reviewed journals.

Bryony Andrews

Senior Quality Controller

Native English

BSc (Hons) in Psychology (2002)

Bryony joined Scinopsis in 2011 as a freelancer and then in 2013 as a full-time employee. Bryony's professional experience includes quality control of documents (including CTD Modules 2.5 and 2.7, phase 1-4 clinical study reports and protocols), reviewing, editing and formatting documents, and writing regulatory reports, business plans and European grant funding applications.

PREVIOUS EXPERIENCE

Quality Controller and Personal Assistant (2011-2013)
Freelance, UK

Manager of a charity (2008-2009)
UK

Professional grant application writer (2003-2008)
Kerrier Council, UK

Sophie Walker

Medical Writer

Native English, intermediate French

PhD in Neuroscience (2016)
MSc in Neuropsychopharmacology (2010)
BSc (Hons) in Experimental Psychology (2003)

Sophie joined Scinopsis in January 2017 following 10 years of experience in behavioural neuroscience research.

PREVIOUS EXPERIENCE

Doctoral Research Assistant (2012-2016)
Swiss Federal Institute of Technology, Switzerland

Research Technician (2007-2012)
University of Sussex, UK

Sophie’s research has focused on understanding the enduring effects of both early life experience and drugs of abuse on brain circuits subserving social, emotional and motivated behaviours.

Sophie has published her research in several peer-reviewed journals.

Lilia De Sequeira

Medical Writer

Native English, intermediate French

Fellowship in Surgery (1996)
MS in General Surgery (1993)
MBBS in Medicine (1991)

Lilia joined Scinopsis in January 2017 following a career in clinical practice.

PREVIOUS EXPERIENCE

Medical Practitioner (2004-2014)
Goa, India

Surgical Fellow (1993-1997)
Royal College of Surgeons, Edinburgh, UK

Lilia has clinical experience in a broad range of therapeutic areas including general surgery; neurosurgery; plastic surgery; vascular surgery; gastroenterology; burns; chronic conditions (e.g. diabetes, hypertension, kidney diseases, liver diseases, asthma); tropical diseases; tuberculosis, and psychiatric conditions.

Francesco Elia

Medical Writer

Bilingual in English and Italian, basic French

PhD in Biology (2017)
MSc in Medical and Pharmaceutical Biotechnology (2012)
BSc in Biotechnology (2009)

Currently enrolled in the EMWA professional development programme in medical writing.

Francesco joined Scinopsis in April 2017 after 5 years of research in cell biology and biochemistry.

PREVIOUS EXPERIENCE

Freelance Scientific Editor (2016-2017)
Doctoral Research Assistant (2013-2016), University of Saarland, Germany

Francesco’s research has focused on protein translocation and protein aggregation. As a freelancer, Francesco has revised numerous scientific manuscripts to facilitate peer-reviewed publication.

Joana Fernandes

Medical Writer

Bilingual in English and Portuguese, intermediate Spanish

PhD in Health Science and Technologies, Molecular and Cellular Biology (2014)
MSc in Molecular and Cellular Biology (2009)
BSc in Biology (2007)

Joana joined Scinopsis in September 2017 after working for one year as a Science Writer and Translator and 8 years as a researcher in cellular and molecular neuroscience.

PREVIOUS EXPERIENCE

Freelance Science Writer, Translator and Specialist Editor (2016-2017)

Postdoctoral Researcher (2015-2016), Faculty of Science and Technologies, University of Coimbra, Portugal

PhD (2010-2014), Faculty of Pharmacy, University of Coimbra, Portugal

Joana’s research focused on the cellular and molecular mechanisms underlying neuronal death in brain ischemia and the role of genetic players in the development of neuropsychiatric disorders, such as autism spectrum disorders. Her research was published in peer-reviewed neuroscience journals.

Joana has also experience writing about new medical and pharmaceutical developments in a broad range of therapeutic areas.

Jonathan Robertson

Medical Writer

Native English

PhD in Neuroscience (2018)
MSc in Cognitive Neuroscience (2013)
BSc (Hons) in Biology (2012)

Jonathan joined Scinopsis in May 2018 following 5 years of experience in cognitive neuroscience and behavioural genetics research.

PREVIOUS EXPERIENCE

Doctoral Researcher University of Sussex, UK

Jonathan developed and used genetic tools to dissect the roles of neurotransmitter receptors in behaviours related to cocaine and alcohol abuse.

Jonathan also has experience in medical imaging and genetic models of neurodegenerative diseases. His research has been published in peer-reviewed journals.