A Senior Publishing Associate position has arisen at an innovative technology-driven multi-speciality healthcare company based at their site in Buckinghamshire, UK. This multinational biopharmaceutical organisation specialises in research and development, and works to develop an unparalleled level of insight into patients’ needs.
Job Role and Responsibilities:
- Publishes submissions within the EMEA (Europe, Middle East and Africa) Region in line with current national and regional requirements for eCTD, NeeS and Paper applications.
- Responsible for ensuring all published submissions are archived in accordance with internal global and regional SOPs.
- Provides guidance (and where necessary training) to EAME Regulatory Affairs staff on all aspects of submission formats/requirements and publishing related software/tools as and when required.
- Builds and maintains relationships with Regulatory and other staff within and outside of the region to ensure effective communication and efficient implementation of regulatory submission strategy and activities.
Education and Experience:
- Graduate (preferably in a Life Science), and previous experience in a Regulatory Publishing setting.
- Good knowledge of European pharmaceutical regulations and guidelines.
- Experience in publishing CP, MRP and DCP submissions, including eCTD, NeeS, and paper formats.
- Good knowledge and experience of all submission types (MAAs, Variations, Renewals, CTAs, ASRs etc)
- Knowledge/experience in publishing submissions for emerging markets (Middle East, Non EU Europe etc).
Essential Skills and Abilities:
- Excellent written , verbal and interpersonal skills
- Excellent knowledge of submission guidance documents and regulations.
- Ability to independently review and adopt new/changing regulatory guidance into existing processes.
- Strong understanding of the registration and maintenance process
- Ability to identify compliance risks and escalate when necessary
- Computer literate with working knowledge of Adobe Acrobat, Microsoft Word, ISI Toolbox, Documentum/First Doc and Liquent's Insight Publisher necessary to perform specific job functions.
- Ability to multi-task, prioritize, and manage multiple projects and deadlines
- Ability to travel
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.