Non-Clinical Medical Writer
- Employer
- Hobson Prior
- Location
- Walloon Brabant, Belgium, Braine-l'Alleud
- Salary
- £72288.80 - £77710.46 per annum
- Start date
- 20 Nov 2020
- Closing date
- 18 Dec 2020
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- Discipline
- Clinical Research, Clinical Development
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Hobson Prior are currently in search for a Non-Clinical Medical Writer to join a global biopharma organisation who are focused on changing the lives of patients living with severe diseases. This role will be based in Braine L'Alleud on a permanent basis.
Job Responsibilities:
- Accountable for the preparation of complex documents such as integrated CTD summaries and IBs, and other core medical writing deliverables. May act as primary author or be available to assist the primary authors where necessary.
- Ensures all documents are authored according to regulatory requirements, internal standards, and with adherence to team expectations.
- Integral member of the global submission team and will participate on multiple cross-functional teams. May act as nonclinical representative. Ensures appropriate and effective collaboration with all key submission contributors.
- Assumes responsibility for adhering to timelines agreed within the global submission team and must demonstrate organisational and project management skills to effectively manage all nonclinical contributions.
- Assumes responsibility for the availability of high-quality SEND datasets as required by the Regulatory Agency.
- Acts as an expert in the use of the organisation's authoring tools ensuring accordance with the organisation's writing styles and regulatory submissions specifications, and as expert in the organisation's Electronic Content Management Systems.
- Ensures maintenance of the Nonclinical Medical Writing trackers via a network of internal and external partners.
Key Skills:
- A meticulous eye to detail.
- Prove ability to organize/execute multiple projects in parallel, prioritize work and meet milestones/deadlines.
- Service mindset.
- Demonstrate creative yet analytical problem-solving skills to find effective solutions.
Requirements:
- You have a PhD, MSc or BSc in a relevant pharmaceutical development science.
- You have demonstrated awareness (5+ years in an equivalent role) of regulatory requirements for the conduct of nonclinical studies including Good Laboratory Practices and ICH guidelines, relevant regulatory submission guidance documents, and SEND requirements.
- You are proficient in the use of standard software including Microsoft® Excel, Word, PowerPoint, authoring tools (ideally StartingPoint and PleaseReview), and in Electronic Content Management Systems.
- You are confident taking the lead on projects.
Apply now:
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
Company
Providing recruitment solutions across the life sciences industry
Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.
Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.
Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.
We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.
Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.
Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.
Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.
Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.
Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.
Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.
- Website
- http://www.hobsonprior.com/
- Telephone
- 01892 612 612
- Location
-
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom
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