Technical Writer - L
- Employer
- ClinChoice
- Location
- Netherlands
- Salary
- Competitive
- Start date
- 17 Apr 2019
- Closing date
- 27 Apr 2019
View more
- Discipline
- Medical Communications
- Hours
- Part Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Technical Writer
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Technical Writer/Compliance Specialist Supply Chain at one of our clients, a leading pharmaceutical company in the south part of the Netherlands.
For our client-facing positions, you must be confident, be able to drive the role and to work autonomously. You will have a close relationship with our Line Managers, who will provide you with mentoring and guidance. Most of our roles are permanent positions with CROMSOURCE and you will be working on studies for just one client. We are open, friendly and approachable and aim to support you through the recruitment process every step of the way.
Job description
- All activities within sponsor's quality system associated with the Supply Chain non-conformance investigations, CAPA records
- First point of contact for identification and alerting of potential deviations to department standard processes
- Ensure timely completion of Supply Chain non-conformances, investigations, CAPAs through the non-conformance procedures
- Support the customer service and transportation teams with a number of writing tasks including completion of Class 1 & 2 NC investigation reports
- Monitor and manage the NC-CAPA team workload for the department, including escalation when timelines for record completion are at risk
- Contribute, oversee, run and participate in root cause analysis, implementing improvements and corrective actions
- Perform trend analysis of non-conformances relating to Supply Chain.
- Ensure investigations constantly reflect current requirements and expectations
- Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information and performance via scorecards and meetings
- Perform tasks and participate on project teams assigned to assist in the timely completion of activities associated with the attainment of group, departmental, team and corporate goals
- Ensure flow of communication to stakeholders
- Develop strong working relationships with International Quality, departmental subject matter experts and managers
- Facilitate (chair) periodic quality management review meetings as well as cross-departmental (Regional Supply Chain/Security/International Quality) meetings addressing compliance/quality topics
- Write and route SOP revisions for reviews and approvals in the documentation system
- Manage assigned change control tasks
- Identify improvement areas and partner to develop business cases
Your Profile
- Third level qualification in Quality or Life Sciences
- Proactive, assertive, well organized person with an eye for detail possessing strong analytical and social skills
- Enthusiastic person willing to learn and grow position-specific skillset
- Strong knowledge of ERP system/GMP compliance
- Experience with electronic Quality Management systems (Track Wise)
- Scientific & regulatory writing skills to produce reports in line with compliance requirements
- Exposure to root cause analysis and other investigation tools (5-whys etc.)
- Apply analytical thinking to evaluate and interpret complex situations/problems using multiple sources of information
- Excellent English verbal and written communication skills including technical writing, presentation and facilitation skills
- Experience with non-conformances, investigations, CAPAs and audits
- Experience of authoring documents in a controlled document system
- Ability to evaluate complex compliance issues
- Ability to work in a fast paced environment with changing priorities
- Work under minimal direction
- Awareness of Change Control philosophy in the cGMP environment
- Understanding of the requirements of Good Distribution Practices
- Microsoft Office experience
- Strong data analysis skills
- Operational excellence mind-set
Minimum Requirements
- Bachelor degree preferably in pharmaceutical studies
- 5 years' experience in (preferably) the pharmaceutical industry
- Strong cGMP and GDP knowledge
- Strong communication and presentation skills (verbal & written)
If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001789 . If you would like to discuss the role before applying through the website, please contact Julie.casteleijn@cromsource.com for more information.
The Benefits of Working for TalentSource in The Netherlands
- Competitive Salary
- Group health insurance
- Great pension scheme
- 25 Holidays per annum
- Internet reimbursement
- Company Car with fuel card depending on the function
- Dedicated Line Manager
- Monthly meetings with line manager
- Full performance and development process with end of year reviews
- Team events and end of year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement
Why choose TalentSource Life Sciences/CROMSOURCE?
TalentSource Life Sciences is a fully dedicated flexible resourcing department at CROMSOURCE, a family owned international, full-service Contract Research Organisation. CROMSOURCE comes from the merger of MSOURCE and CROM and we have been supporting clients with outstanding clinical research and resourcing services since 1994. Successful growth has been achieved by putting high quality and client focus at the heart of everything we do and we are proud to partner with industry leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide.
Our employees are the most valuable company asset and because we want to retain our staff, we 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. The success of these core values are evidenced by our current below industry average turnover rates.
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 experts providing experts - 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.
How can we help you on your next career move? Learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.
Skills: Medical Writer, Technical writer Location: Netherlands
Company
ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.
We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
- Website
- https://clinchoice.com/
- Telephone
- +44 1628 566121
- Location
-
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom
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