Location: Ireland Dublin
Closing Date: 25 Oct 16
Type: Full Time
Salary (£): On Application
Job Summary Do you want to work for a Global Pharmaceutical company where you will get recognised for your hard work and commitment? Novartis is currently recruiting for a Medical Writer to join the Dublin team. ...
Do you want to work for a Global Pharmaceutical company where you will get recognised for your hard work and commitment? Novartis is currently recruiting for a Medical Writer to join the Dublin team.
The Senior Regulatory Medical Writer is responsible for protocol and related documents (patient inform consent form, amendments, study concept sheet) development, ensuring the review/reporting of quality trial data, and study reporting/publishing in compliance with Novartis processes, GCP/ICH and regulatory requirements.
• Protocol Development ( and protocol related documents: inform consent form, amendments, study concept sheets, as appropriate).
• Lead the clinical trial protocol development process in collaboration with CPO/Region representative (Medical Advisor, statistician, regulatory, etc...) or external expert recommended by customer.
• Translating the approved trial concept sheets into executable clinical pro-tocol (and Inform Consent Form) ready for customer "Protocol Review Committee" review/approval.
• Translate study scientific and operational elements into a high quality concept sheet for review and approval by Head Quarters as appropriate.
• Responsible, in collaboration with the clinical trial team for preparation of high quality clinical study reports. Participate in planning of analysis, meetings and data presentations to be used in study report.
• Responsible for clarification of requirements from customer prior to start protocol/concept sheet/ study report development.
• Incorporate input from experts (Medical Advisor, Statistician, safety, DRA as appropriate) while ensuring that feasibility at site level, patient safety and trial objective (i.e. publication) are considered when developing the document(s).
• Coordination of the protocol, study report versions reviews and approval processes in collaboration with key contributors and customers.
• Liaise with MedCom Medical Writers to review, further expand bibliography (list of publications) supporting protocol rationale. Ensure document quality check performed prior to release every version (draft and final)
The Novartis Global Service Center (NGSC), Dublin, was set up in 2013 and is located in a state-of-the-art facility on the Merrion Road in Ballsbridge. The center, one of five around the world, delivers a broad variety of services to the Novartis divisions and organizations worldwide. Services offered by the Dublin team include scientific and commercial services, IT, HR Operations and Procurement. There are currently several hundred associates employed at the site with 32 nationalities speaking 28 languages.
The operation is continuing to grow rapidly and has a number of exciting vacancies for experienced high-calibre candidates who are interested in working as part of an international team delivering services globally. Novartis offers a rewarding career and a comprehensive benefits package.
Novartis is a world-leading healthcare company that provides innovative solutions to address the evolving needs of patients and societies. Headquartered in Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. Novartis Group companies employ approximately 120,000 full-time-equivalent associates and its products are available in more than 180 countries around the world.
Benefits of Working for Novartis
Competitive salary; Annual bonus
Pension scheme; Share scheme
Health insurance; 25 days annual leave
Flexible working arrangements
Subsidized dining facilities
Employee recognition scheme
‘I came for the job, I stay for the culture’
#LI-P Minimum requirements Requirements
• Advanced degree or equivalent education/degree in life science/healthcare is required. Fluent English (oral and written).
• At least 6+ years operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization. Experienced in protocol and study report development.
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process. Including protocol and trial regulatory documentation development ( clinical study report)
• Demonstrates excellent scientific writing skills, experienced medical writer a plus.
• Proven ability to work independently, with multidisciplinary trial team in a complex matrix environment (including remote).
• Expert skills to facilitate/optimize contribution of team members.
• Strong interpersonal, communication and diplomatic skills. Rigorous, details oriented.
• Ability to work under tight timelines
• Ability to resolve issues with minimal supervision and understand when to escalate.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons
Novartis Pharmaceuticals UK Limited
Frimley Business Park
|Tel:||+44 (0)1276 692255|
|Fax:||+44 (0)1276 692508|
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