Professional Pedigree and Work Experience
I am a postdoctoral virologist with clinical research experience gained in the Contract Research Organisation (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 hold the European Medical Writers Association (EMWA) Advanced (awarded 2013) and Foundation (awarded 2007) Level Medical Writing Certificates.
As an active member of EMWA since 2004, serving on the Executive Committee from May 2014 – May 2016 (President [2015 to 2016], Vice President [2014 – 2015]) I have initiated, developed and delivered several major initiatives to support the long-term vision for EMWA, including programmes to retain experienced members and influence our industry:
- Expert Seminar Series: delivered expert educational content in a programme of six seminars per conference, tailored for experienced members. May 2015, May 2016
- Chair, CORE Reference project (May 2014 – May 2016) http://www.core-reference.org
- Launched EMWA Regulatory Public Disclosure Special Interest Group (RPD SIG) May 2016
- Launched EMWA Pharmacovigilance Special Interest Group (PV SIG) November 2015.
Member Activities (from 2007):
- ESS lead for Birmingham 2017
- Editorial Board Member of ‘Medical Writing’ (MEW) March 2012 – September 2014
- Co-founder of the freelance section, ‘Out on Our Own’ MEW (formerly ‘The Write Stuff’)
- Guest Editor of ‘The Write Stuff’, March 2009, themed issue ‘Regulatory Medical Writing. Archive: http://www.samhamiltonmwservices.co.uk/blog
- Chair of the Freelance Business Forum at international EMWA conferences, 2006-2014
- Freelance Business Survey, 2007 and 2012
- President’s Sub-Committee 2008-2010, 2012-2013
- Conference Content Organising Committee – Ljubljana 2009; Lisbon 2010; Berlin 2011; Paphos 2012; Manchester 2013
- Workshop presenter:
- Foundation Level Workshop entitled ‘Standard Operating Procedures: Processes and authoring’ 2009 –
- Foundation Level Workshop entitled ‘Clinical Study Report Appendices’ 2011 –
- Advanced Level Workshop entitled ‘Scheduling and Proposal Writing: The Clinical Study Protocol and Report’ 2008 -.