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Highly organized and motivated self- starter with consistent ability to meet deadlines. Proven co-ordinater with outstanding communication and presentation skills.
Janine Farlam
,
Stoke-on-Trent, United Kingdom
Experience
Other titles
Skills
I'm offering
Educated to BSc hons level (2.1) with several years experience in research and project management using a wide variety of techniques and more recently in Regulatory Affairs. Highly organized and motivated self- starter with consistent ability to meet deadlines. Proven co-ordinater with outstanding communication and presentation skills.
Current Position
Nov 16 - present JD Farlam Ltd
Self employed consultant specialising in Regulatory Affairs, Project Management, Scientific Writing and Proofreading, Data Analysis.
Current Position
Nov 16 - present JD Farlam Ltd
Self employed consultant specialising in Regulatory Affairs, Project Management, Scientific Writing and Proofreading, Data Analysis.
Markets
United Kingdom
Language
English
Fluently
Ready for
Larger project
Ongoing relation / part-time
Available
My experience
2009 - 2016
job
Global Regulatory Affairs Officer
Nutricia Advanced Medical Nutrition.
L7 9PT
Key Responsibilities: Ensuring product compliance with current legislation;
Supporting new registration and reimbursement applications globally and ensuring that any product changes are correctly notified to appropriate authorities; Advising on new product development and proposed changes to current products; Liaising with country business units to keep abreast of changes to market registration or reimbursement procedures;
Ensuring that labelling and promotional literature meets current regulatory requirements.
Key Responsibilities: Ensuring product compliance with current legislation;
Supporting new registration and reimbursement applications globally and ensuring that any product changes are correctly notified to appropriate authorities; Advising on new product development and proposed changes to current products; Liaising with country business units to keep abreast of changes to market registration or reimbursement procedures;
Ensuring that labelling and promotional literature meets current regulatory requirements.
Product development, Compliance, Development, Regulatory Affairs, Regulatory
2008 - 2009
job
Regulatory Officer
NHC Technology Ltd, Colomendy Industrial Estate.
LL16 5TS
Key responsibilities included, ensuring that the company's products comply with the regulations of the Medical Device Directive; keeping abreast of international legislation, guidelines and customer practices; keeping up to date with a company's product range; updating technical files as appropriate; developing and writing clear arguments and explanations for new product licences and licence renewals; in particular, compiling medical evidence; writing clear, accessible product labels and patient information leaflets; maintaining quality systems;
Key responsibilities included, ensuring that the company's products comply with the regulations of the Medical Device Directive; keeping abreast of international legislation, guidelines and customer practices; keeping up to date with a company's product range; updating technical files as appropriate; developing and writing clear arguments and explanations for new product licences and licence renewals; in particular, compiling medical evidence; writing clear, accessible product labels and patient information leaflets; maintaining quality systems;
Writing, International, Regulatory, Medical device, UP
2005 - 2008
job
Project Manager
NuPharm Laboratories Ltd.
2 Newtech Square, Deeside Business Park, Flintshire, CH5 2NT
Co-ordination of projects - tracking projects and keeping up to date records of project milestones.
Ensuring deadlines are met.
Ensuring relevant personnel are kept up to date.
Liaising with clients.
Co-ordination of projects - tracking projects and keeping up to date records of project milestones.
Ensuring deadlines are met.
Ensuring relevant personnel are kept up to date.
Liaising with clients.
Project Manager, UP, Manager
2004 - 2005
job
Programme Administrator, LJMU
IM Marsh Campus.
Responsible for the administration of Primary teaching and Education Studies programmes within the campus.
Administration, Teaching, Administrator
2000 - 2004
job
Senior Laboratory Technician, Diagnosteq
Division of Equine.
I was responsible for the day to day running of a small spin-out company specialising in equine parasite diagnostics. My position involved both laboratory skills and administrative skills.
1999 - 2000
temp
Development Scientist
Medeva Pharma.
Working to GLP in a Development laboratory. My time was spent developing new assays and improving existing ones. I performed routine immuno-assays (mainly ELISAs) and a routine enzyme kinetic assay, which I developed. I wrote SOPs, reports and protocols. I was the training co-coordinator for the Analytical team and a member of the Development library team.
Training, Development, Coordinator
My education
1994
-
1997
University of Liverpool School of Biological Sciences
BSc, Biochemistry
BSc, Biochemistry
1992
-
1994
Wirral Metropolitan College
ASc, Biology
ASc, Biology
1974
-
1979
Oldershaw Senior Comprehensive School
Secondary, Geography and German
Secondary, Geography and German
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