Regulatory Disclosures Manager in Welwyn Garden City - Roche

Job Overview

Welwyn Garden City, England
Job Type
Full Time
Date Posted
9 days ago

Additional Details

Job ID
Job Views

Job Description

The PositionRegulatory Disclosures ManagerRoche are at the forefront of developing ground-breaking new medicines and consistently pushing the boundaries of conventional thinking and embracing innovation across our business. With a strong pipeline, we are looking for people to support global teams to develop and gain approvals for medicines in Europe and Rest of the World countries.We are currently looking for an experienced Disclosures Manager in the Regulatory Function who can join our team.We have a Permanent and a Fixed Term Contract option available. Primary Responsibilities and AccountabilitiesResponsible for the accurate and timely posting of applicable Roche and Genentech clinical trial protocols, protocol amendments and study results onto the public registries ( (CT.Gov) and EudraCT).Identify and accurately assess clinical trial studies required for registry and results postings, including applicable clinical trials for results posting on CT.Gov.Liaise with clinical study teams and other applicable groups/stakeholders (e.g. biostatisticians, medical writers, clinical operations, clinical scientists) to ensure that they understand responsibilities, disclosure registry requirements, timelines and deadlines and to ensure timely review and approval of documentation for registry and results records.Coordinate registry and results record creation with contract medical writing personnel, providing documentation, contacts and work prioritization when necessary; facilitate adjudication of comments between clinical study teams and medical writers.Track and monitor workflows for registry and results entries to ensure timely completion of activities; track correspondence within Roche and Genentech via a shared global inbox and ensure applicable responses are provided in a timely manner.Operate applicable systems to complete the necessary uploads; trouble-shoot system issues with teams and technical support.Actively contribute to the development and maintenance of policies and/or Standard Operating Procedures on clinical trial registry and clinical trial results database processes.Actively contribute to Team Knowledge Sharing meetings and to company initiatives as required.Professional and Technical RequirementsQualifications and Experience:Previous direct regulatory disclosures experience required.Solid experience with (CT.Gov) registration, maintenance and results posting activities and/or EudraCT results posting activities along with the use of disclosures management systems e.g. PharmaCM.Well versed with the CT.Gov (FDA) and EudraCT (EMA) registry legal requirements and deadlines; familiarity with other public and local registries (e.g. EU PAS; ISRCTN) desired.Demonstrated pharmaceutical/biotechnology industry experience including experience in interacting with stakeholders globally along with working closely with Vendors/CROs.Graduate degree in Life Sciences or equivalent (life sciences disciplines preferred).Experience with medical writing or editing; familiarity with Protocol Documents and Clinical Study Reports.Understanding of the drug development process; understanding of the regulations, processes and systems related to clinical trial registries and disclosure, particularly CT.Gov.Fluency in English, excellent communication skills, both verbal and written; ability to interface with senior staff in other groups.Robust knowledge of Microsoft office applications (Word, Excel, PowerPoint); organized and methodical approach to work, accuracy and attention to detail.Solid understanding of IT processes and systems, especially clinical trial management systems as well as document and workflow management systems.Desire and ability to work under minimal supervision.Strategic thinking along with analytical and conceptional skills. Solution oriented team player.Able to multitask and effectively handle multiple activities at the same time, with tight and competing timelines and deadlines for completion. If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you. We will provide all the support you need to further your career here in ways you might never have considered. Best of all, you are going to work with some of the most inspiring and friendliest people you could hope to meet.Good luck with your application.Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions. Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK. Roche is committed to creating a diverse & inclusive environment. The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche.The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.SummaryLocation: WelwynType: Full time

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