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Regulatory Submission Specialist

Job Field:
Regulatory and Drug Safety Jobs
Discipline:
Regulatory Affairs Jobs
Country:
India
Region:
India All
Contract Type:
Permanent
Currency:
Unspecified
Salary Description:
Competitive
Posted:
16-Jul-19
Recruiter:
Clintec
Job Ref:
3493

Are you a Regulatory publishing/ Submission Specialist interested in a new challenge with an award-winning, global CRO?

Clintec is a business built around people who strive for excellence, and we currently have an exciting opportunity available for an experienced Clinical Data Manager to join our team in the India supporting various client. The role will be Office based, so we can consider candidates working in Bangalore.

THE ROLE:

Perform a through format check on documents before initiating a publication to ensure they are submission-ready and comply with standards.
Prepare electronic compilations of scientific (clinical/regulatory) documents in accordance with the functional and regulatory requirements on submissions – hyperlinks, bookmarks, pagination, TOCs, validation, eCTD – using appropriate prequalified systems/applications.
Perform a technical/administrative check on publications, before sending off to stakeholders for sign off.
Keep electronic document management system (EDMS) up to date and compliant with internal processes and archiving requirements.
Contribute in preparation of high quality registrations and postings to ensure timely disclosure of accurate, consistent, and complete information of clinical trials on public databases (e.g. clinicaltrial.gov, ENCePP).
Perform marking and redactions of CCI and PPD information inside scientific documents (eg protocols, clinical study reports).

WHY JOIN CLINTEC?

At Clintec, we understand that our people are our biggest asset and we value the hard work and dedication of all our employees.

By joining the Clintec team you can expect:

A competitive salary and benefits package including private healthcare, dental and vision cover, life assurance and flexible benefits
25 days annual leave plus public holidays
Real career development opportunities and a life-long career with an innovative, forward-thinking clinical research company.

​Click Apply Now to send your CV of email us directly on careers@clintec.com for more information!


THE COMPANY

Clintec (an IQVIA company), established for 22 years, is an award-winning, full-service global clinical research organisation with our HQ office based in Scotland, UK. We support key product development and manage clinical trials in over 50 countries worldwide, across all major therapeutic areas, with expertise in Oncology and Rare Disease studies. We differ from other players in the clinical research industry as we combine the agility and flexibility typical of smaller CROs with the global coverage and management associated with large CROs.

Find out more by visiting www.clintec.com

Closing Date:
13/08/2019

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