Document Writer - Maternity Cover

Unfortunately we are unable to offer visa sponsorship for this role.

30-35 hours per week.  4-5 days. Monday - Friday. 

Purpose of the post:

Reporting to the Senior Manager at Eurofins Alba you will assist in producing clinical research and regulatory submission documents such as protocols protocol amendments subject information sheet and informed consent documents clinical study reports etc.

You will ensure that the company is meeting global regulatory requirements and adhering to guidance documents such as International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) while still fulfilling the needs preferences and styles of sponsors and/or study teams.

Main Duties:

• Assist in the development revision and maintenance of clinical study synopsis documents and protocols clinical study reports and other technical documents.
• Responsible for authoring and finalising documentation.
• Interpret understand and contribute to the scientific details of the protocol/technical documentation.
• Identify and resolve gaps to ensure client satisfaction.
• Assist in initiate and manage multiple rounds of document review. 
• Ensure high quality documentation that meets regulatory requirements; proofread and copy-edit content as needed.
• Liaise and drive timely collaboration between key stakeholders to ensure technical documentation meet high quality standards and aligns with business process.
• Prepare ethical study submissions.
• Author high quality corporate documentation as assigned.
• Aid with the development of new services to meet the needs of clients.
• Nurture develop and maintain relationships with business stakeholders including clients partners or vendors.
• Provide specialist advice on the products and/or services of the company.
• Lead client interactions in support of technical documentation associated with studies.
• Assist Project Managers in the set-up of study information and communication in relation to Protocol and Report production.
• Participate in client interactions during study start-up activities and/or during study amendment process.
• Liaise with 3rd Party Consultants/Subcontractors in the production of 3rd party reports e.g. Statistician Dermatologist
• Resolve challenges and build consensus between all cross-functional groups and collaborators in a timely manner.
• Identify develop and execute continuous improvement projects associated with study documentation.
• Aid in the development of Standard Operating Procedures and associated training.
• Manage ad-hoc process improvement/remediation projects as required.

Qualifications :

• Clarity in professional writing
• Awareness of GCP (Good Clinical Practice).
• Familiarity with best practices for structuring reports and technical documents.
• IT literate
• Microsoft Office (Excel Word)
• Fast and accurate typing skills 
• Attention to Detail
• Compliance & Accuracy Problem-Solving
• Effective communication skills both written and oral.
• Organised.
• Good time management.
• Strong background in writing reports research summaries and structured documents.
• SCQF Level 4 or above in English

Additional Information :

Benefits

At Eurofins we are growing innovating and always learning. We celebrate the achievements of our employees through annual long service awards recognise our colleagues special life events and we are committed to charitable causes through global fundraising activities.

As a Eurofins employee you will benefit from:

• Enhanced Annual Leave Entitlement
• Annual Leave Sellback Scheme
• Additional Annual Leave at Employees set service dates   
• Company Pension Plan
• Life Assurance Scheme (4 times annual salary)
• Healthcare Cash Plan (6 months service)
• Enhanced Maternity Adoption and Paternity Schemes
• Employee Assistance Programme 24/7 confidential
• Health and Wellbeing Programmes
• Worldwide career opportunities
• We also have in place rewards recognising the great work our employees deliver their dedicated service and celebrating special life events.

What Happens Next
Our people are the backbone of what we do so its incredibly important we find the right individuals to join us. As a potential new recruit youll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and its requirements this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths. 
 
Your data 
As part of any recruitment process the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.
 
Closing Date
We reserve the right to close or extend this position depending on application numbers. Therefore we would urge candidates to submit an application as early as possible.
 
Due to the high volume of applications we receive please be aware that if you do not receive a response within 4 weeks of the vacancy expiry date unfortunately on this occasion your application has been unsuccessful. 

We support your development! Do you feel you dont match 100% of the requirements Dont hesitate to apply anyway! Eurofins companies are committed to supporting your career development.

We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression race nationality age religion sexual orientation disability and everything else that makes employees of Eurofins companies unique.

Sustainability matters to us! We encourage our laboratory leaders to make sustainable changes at their local level and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal!

Find out more in our career page:  Work :

No