Sam Hamilton Medical Writer | Freelance Medical Writer
Freelance Medical Writer
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Sam Hamilton Experience

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
• Co-founder of and a 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
• President’s Sub-Committee
• Ljubljana May 2009 Conference Content Organising Committee
• Accredited workshop presenter:
o Foundation Level Workshop entitled ‘Standard Operating Procedures: Processes and authoring’
o Advanced Level Workshop entitled ‘Scheduling of Medical Writing Deliverables: The Clinical Study Protocol and Report’.

 

Medical Writing Experience

 

Study Specific Deliverables

I have prepared 60+ 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

• Brain
o Depression
o Hepatic encephalopathy
o Mixed and vascular dementia
o Paediatric schizophrenia
       o Alzheimer's disease

• Cancer
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

• 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

• Ophthalmology
o Glaucoma
o Blepharospasm

• 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

• Virology
o Hepatitis C
o Influenza

• Wounds
o Minor surgical wound treatment.

 

 


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