PDR Disclosures Coordinator

Key People

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Job ID :

15300


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Hertfordshire,Hertfordshire,


Key Skills :

PDR Disclosures Coordinator, Registry, CSRs, GxP, GCP, FDA, EMEA, NICE, Clinical Development, CFR Pr


Salary :

£25.00 - £35.00 per hour


Date Posted :

18 Sep, 2019



Company Name :

Key People


Location1 :

Hertfordshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

My client, a large highly successful pharmaceutical company, is currently looking for a PDR Disclosures Coordinator on a 12 month contract basis based in Hertfordshire. This will be a full time role paying up to £35p/h.

Responsibilities Overview:

· Taking group meeting minutes
· Data entry for the registration, maintenance, and results for ClinicalTrials.gov, EudraCT, and EU PAS registries
· Participates in site and/or regional PD Regulatory Disclosures departmental meetings
· Stays abreast of internal and external developments, trends and other dynamics pertaining to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for Roche therapeutic areas and product development projects. Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics
· Obtains and applies detailed knowledge of Roche and regulatory guidelines, procedures and best practices
· As required, provides regulatory disclosures expertise to cross-functional teams and various groups
· Contributes to development and maintenance of policies and/or Standard Operating Procedures (SOPs) on clinical trial registry and clinical trial results database processes
· Identifies studies neccessary for registry and results postings, including relevant trials for results postings on relevant external websites. Ensures that responsible PDR management and staff are aware of timelines, deadlines and other requirements
· Tracks missing/late registry entries and Clinical Study Reports (CSRs) and communicates with PDR teams regarding dates of new product or line extension approvals
· Works with cross-functional team members to gather data, reviews and approvals needed for completion of registry and results entries on internal and external websites
· Oversees workflows for registry and results entries to make sure of timely and on-target completion
· Completes document and data uploads in applicable systems
· Ensures protocol information is included in the registry as soon as the study design is completed and first ethical/regulatory approval is received
· Ensures that study results are uploaded into results databases within neccessary timeframes
· Tracks correspondence with cross-functional teams and departments via departmental mailboxes and ensures suitable responses are provided in a timely manner

· Participates in routine and ad hoc departmental meetings and other business reviews or meetings to remain, at all times, fully up to speed with evolving internal and external needs and requirements. Expected to share best practices within the department and cross-functionally, identify and relay opportunities for departmental enhancements and efficiencies
· Consistently complies with all governing laws, regulations, SOPs and other guidelines

If the above may be of interest and you feel you have a suitable profile, please apply and get in touch with Ross Wilson at rwilson@keypeople.co.uk


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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