I am a postdoctoral virologist with clinical research experience
gained in the CRO sector between 1994 and 2006. My strategic
understanding of the drug development process is gained through
my multidisciplinary background in clinical monitoring, project
management and medical writing. Trained in the fast-paced
working environment of the CRO industry, I understand the
need to respond to often rapidly changing client requirements.
I have experience of working with academic groups, large
and small CROs, pharmaceutical and biotechnology companies.
I understand the need for confidentiality, and am experienced
in working to exacting timelines dictated by regulatory deadlines.
In my last company position before becoming freelance in
October 2006, I managed the UK Medical Writing Group for PRA
International (the 5th largest CRO in the world). I
was home-based with a team of writers located throughout the
UK. I directed writing teams with members located in
Europe and the US, managed the resourcing of projects for
the wider European team, managed and delivered the European
team training programme, contributed to all client requests
for proposals, participated in client bid defence meetings
and collated monthly metrics for the UK team. As an
experienced writer, I was one of six members of the Global
Medical Writing Standards Committee charged with shaping medical
writing policy and procedure for harmonisation of six PRA
office locations worldwide.
As an established regulatory freelance writer, I continue
to work with CROs, pharmaceutical and biotechnology clients
worldwide to deliver high quality regulatory writing deliverables.
I am an active member of the European Medical Writers Association
(EMWA). Activities include:
• Organisation and reporting for the Freelance Writers’
Salary Survey, 2007
• Co-chair of the Freelance Business Forum at international
meetings 2007-2011
• Chair of the Freelance Business Forum at international
meetings 2011-
• Co-founder of and regular columnist for the freelance
section, ‘Out on Our Own’ published quarterly
in the EMWA publication, The Write Stuff. An archive of my
articles is available at http://www.samhamiltonmwservices.co.uk/blog
• Guest Editor of The Write Stuff, March 2009
• President’s Sub-Committee 2009
• Ljubljana 2009; Lisbon 2010; Berlin 2011; Paphos 2012
- Conference Content Organising Committee
• Workshop presenter: o Foundation
Level Workshop entitled ‘Standard Operating Procedures:
Processes and authoring’ 2009 - o Foundation
Level Workshop entitled ‘Clinical Study Report Appendices’
2011 - o Advanced
Level Workshop entitled ‘Scheduling and Proposal Writing:
The Clinical Study Protocol and Report’ 2008 -.
Medical
Writing Experience
Study Specific Deliverables
I have prepared 80+ deliverables for 30+
pharmaceutical and biotechnology companies
in 12+ countries (Europe, USA and Hong Kong)
including:
• Feasibility reports
• Clinical study protocols/protocol
amendments
• Clinical study reports
• Abbreviated clinical study reports
• Patient narratives
• Bespoke reports
• Investigator brochures and IB updates
• Integrated summaries of efficacy
• Integrated summaries of safety
• Clinical summary sections of regulatory
submission documents
• Literature reports
• Manuscripts
• Newsletters
• Value core dossiers to support product
pricing
• Quality control of all deliverables.
Company Confidential Documents
I have prepared a range
of internal (company confidential) documents
including:
• Standard operating procedures
• Departmental working procedures
• Electronic marketing brochures.
Clinical
Research Experience
Positions held
• Clinical research
professional since 1994
• 5 years in clinical
monitoring and project management
• Medical writer since
1999 including 2 years of managing
the UK Medical Writing Group
for a major global CRO
• Freelance medical writer
since October 2006.
Therapeutic
Experience
My therapeutic experience is diverse
and I welcome the opportunity to broaden
my range which includes:
• Allergy
o Seasonal allergic conjunctivitis
• Autoimmune
o Rheumatoid arthritis
• Bone
o Primary osteoporosis
o Osteoarthritis
• Brain
o Depression
o Hepatic encephalopathy
o Mixed and vascular dementia
o Paediatric schizophrenia
o Alzheimer's disease
• Cancer: Solid tumours
o Advanced/metastatic solid tumours
o Breast cancer
o Hepatocellular carcinoma
o Non small cell lung cancer
o Renal cell carcinoma
o Pancreatic cancer
o Colorectal cancer
o Hepatic metastases
o Squamous cell cancer of the head
and neck
• Cancer: Blood
o Hodgkin's lymphoma
o Hodgkin's lymphoma
o B-cell chronic lymphocytic leukaemia
• Cardiovascular
o Essential hypertension
• Dermatology
o Atopic dermatitis
o Psoriasis
o Tinea pedis
• Devices
o Ventilator-associated pneumonia
o Immunoadsorption column
o Intratumoural radiological device
• Endocrinology
o Type 2 diabetes mellitus
o Menopause
• Gastrointestinal
o Ulcerative colitis
• Hepatic
o Hepatic encephalopathy
o Liver transplantation
o Hepatic metastases
o Hepatocellular carcinoma
• Infection
o Fungal systemic infection
o Influenza
o Intra abdominal infection
o Lower respiratory tract infection
• Metabolic
o Phenylketonuria
• Neurology
o Multiple sclerosis
• Ophthalmology
o Glaucoma (open-angle; pseudo-exfoliative)
o Blepharospasm
o Ocular hypertension
• Orthodontics
o Post-operative dental pain
• Pain
o Dysmenorrhoea
o Local analgesia
o Non-malignant pain
o Post-operative dental pain
o Soft tissue injury
o Fibromyalgia
o Osteoarthritis
o Sore throat
o Post-herpetic neuralgia
o Malignant pain
• Renal
o Renal dialysis
o Renal transplantation
o Renal cell carcinoma
• Respiratory
o Asthma
o Lower respiratory tract infection
• Vaccines
o Influenza
o Human rhinovirus
o Respiratory syncytial virus
• Virology
o Hepatitis C
o Influenza
o Human rhinovirus
o Respiratory syncytial virus
• Wounds
o Minor surgical wound treatment
o Dental implantology - surgical site
infection.
o Foundation
Level Workshop entitled ‘Standard Operating Procedures:
Processes and authoring’ 2009 -