Medical Writer / Clinical Trial Application Specialist

Recruiter
CROMSOURCE
Location
Bedfordshire
Posted
25 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
TalentSource Life Sciences is currently searching for an experienced Medical Writer to work with one of our partner pharmaceutical companies in the South of England.This is a freelance position with TalentSource for 6 months with the possibility of being extended, on a full time basis. This will be an office based position along the M4 Corridor initially, with potentially some flexibility to work from home after the first 3 months. The successful candidate will be working on studies dedicated to one client.TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.Key Accountabilities:The Medical Writer will be responsible for the regulatory management of UK Clinical Trial Applications (CTAs) for assigned products through national and VHP procedures.This role contributes to the UK affiliates success by enabling clinical research and maintaining the Company's Licence to Operate.Responsibilities:· Ensure quality regulatory submissions are prepared and submitted in a timely manner in collaboration with colleagues to obtain and maintain CTAs compliantly. Ensure approvals and changes are implemented.· Demonstrate current knowledge of regulatory Clinical Trial procedures.· Provide guidance on relevant regulatory issues to support internal customers.· Timely communication of regulatory activities and timelines to support customers.· Assess technical and scientific content of proposed CTA submissions to meet requirements. Propose solutions to correct deficiencies.· Represent Regulatory Affairs as CTA primary contact at a local level.· Product level approach to work, interfacing with local contacts.· Ensure submissions, questions and commitments from our national regulatory authority are proactively tracked, managed and addressed in liaison with local and HQ colleagues.· Ensure issues are escalated and key information is shared.· Share expertise across the department with other function and ply knowledge to new assets and situations.· Contribute to efficiency and process improvement including development of best practices, SOP maintenance and appropriate tracking tools and templates.· Acquire and maintain CTA knowledge and support department training and compliance in this area.· Awareness of and compliance to laws and regulations applicable to business area, all company policies and procedures including HR, Finance, Procurement, IT and Legal, and with all relevant industry codes and guidelines.· Demonstrate ownership of comprehensive understanding of regulations and SOPs: Learning gaps identified and actions taken to access required training· Attendance at all requisite training sessions and completion of all requisite online training and compliance programmes within specified time limit.· Education / Qualifications:· Bachelor's Degree or equivalent in a scientific discipline.· Advanced degree preferred.Experience, Skills & Knowledge:· Must have previous experience in Regulatory Affairs, with a working knowledge of EU/UK CTA management and GCP.· Able to plan and manage multiple CTA submissions· Excellent attention to detail and accuracy· Good communication skills, teamwork and IT skills (MS Office, TrackWise)· Demonstrated clear, high-quality scientific writing style in the English language· Project management skills: consistently achieves multiple tasks and goals on-time· Ability to work effectively in a team environment, establishes strong collaborative relationshipsIf you have the experience and are interested in discussing the role for this position, please contact Laura Guascone Consultant, TalentSource Life Sciences Unit, Laura.Guascone@cromsource.com.Why TalentSource Life Sciences/CROMSOURCE?CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.Keywords: Medical Writer, Regulatory, Clinical Trial Application, CTA, Documentation Specialist, Submissions, Clinical Trial Specialist, CTS, MW, CRO, Outsourced, Contract Research Organisation, Freelance, Temporary, Contractor, Freelancer, Contract, Pharmaceutical, Pharmaco Medical Writer, Freelance

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