Medical Writer North West 6 Month contractSRG are currently recruiting for a Medical Writer to join a Life Science manufacturer in the North West on...
Freelance/Contract Clinical Specialist, North West, UK, Chester, office-based - Medical Devices6 month contractCompetitive daily rate, office-basedStart date: ASAP
Experienced Clinical Specialist - a unique opportunity for a healthcare professional to join a highly reputable, truly global and a market leading medical device company specialising in advanced wound care. As a Clinical Specialist you will represent and conduct clinical activities on projects related to margin improvement program. A succesful candidate must have 'can-do' attitude coupled with experience in clinical affairs experience in clinical affairs of product development, risk management processes and launch process is a must.Major responsibilities:
- Represent clinical affairs on project teams for product development and change control including risk assessments and IFU development.
- Review and provide input into design history file remediation activities including design verification/validation, hazard analyses, product risk reviews and to prepare and/or update Clinical Evaluation reports.
Prepare and update Clinical Evaluation Reports for inclusion in the technical file in accordance with MEDDEV 2.7.1 and GHTF Guidance and internal SOP's. This will include preparing systematic literature reviews, complaint analysis and overall analysis of clinical evidence for presentation to the Clinical Evaluator.
- Communicates and works closely with other departments such as R&D, Regulatory Affairs, Quality Management and Marketing to ensure timely completion of clinical documents for Regulatory filings and clinical responses to health authorities.
- A full understanding of the clinical product development process
- Works both as a team member and independently, engages and supports other members of the team and willingly accepts support when required. Is able to make decisions, in consultation, if required, and accept accountability.
- Willingly embraces change and the need to adapt to new circumstances. Takes an innovative approach while maintaining compliance.
- Has demonstrated principled leadership and sound business ethics: shows consistency among principles, values and behaviors.
- Seeks and welcomes feedback, responds to coaching, takes action to change.
- Effective use of oral and written communication skills to influence, inform or guide others.
In addition to:
- Understanding of the medical device industry and of the pre-clinical, clinical, marketing and regulatory components.
- A proven ability to deliver results according to timelines. Anticipates problems and creates solutions to minimize potential delay.
- Solid understanding of project planning and project management methods and the ability to apply them.Knowledge of team building strategies, communication and interpersonal skills.
Training and development:Initial induction will be provided. To apply:Click on the "apply" button today. Alternatively for immediate consideration contact Mariusz Stokowacki on +44 (0)203 096 4703 or email About SRG:SRG is the market leading supplier of Clinical and Drug development recruitment services to the Life Sciences industries. By putting people at the heart of what we do we are the catalyst that connects the best talent with organisations in the pursuit of 'Creating Tomorrow's World'& helping patients world-wide.Our team at SRG Clinical also cover roles in Clinical Operations (CPM, CRA etc.), Biometrics (Statistics, SAS programming, Data Management), Medical information, Medical Affairs, Pharmacovigilance and Regulatory affairs so do not hesitate to call us at +44 (0)203 964 700.Key words:CRO, Pharma, Pharmaceutical, Biotechnology, Biotech, Clinical Research Organisation, Medical Device, Permanent, Freelance, Contract, Part-time, Temporary, Clinical Research, Administrator, Assistant, CTA, Clinical Trial, Associate, Project Management, Senior, Manager, Career, Clinical Research Associates, CRA, SCRA, Clinical Monitoring, Site Monitor, Site Manager, CPM, Clinical Trial Manager, Study Director, Project Leader, Diagnostics, In-Vitro, IVD, Laboratory, Reagents, Non-interventional, Therapeutic Areas, Indication, Oncology, Respiratory, Cardiovascular, cardiology, Rheumatology, Diabetes, Ophthalmology, Dermatology, Urology, CNS, Neurology, hematology, orphan diseases, nephrology, musculoskeletal, endocrinology, gastroenterology, clinical research nurse, clinical educator
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.