Global Delivery Senior Manager job in Berkshire, England

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Publishing & Submissions

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

An exciting opportunity has arisen for a Senior Global Delivery Manager at a multinational biotechnology company in Berkshire. The bright individual will be able to step up and grow organically within the company which is perfect for an individual who is looking for a career development.

Job Responsibilities

Responsible for global electronic submissions and documents meeting regulatory agency and internal submission standards and technical requirements.
Demonstrates expert knowledge of submission or technology-related Global Health authority guidelines/regulations.
Oversees publishing deliverables and vendor activities on a day to day basis to ensure successful execution of operational activities for assigned products.
Internal influencing, socializing and communication of changes.
Responsible for understanding and communicating impact of Industry / Agency changes relevant to submission sciences, in partnership with vendor and driving innovative process change for improved efficiency.
Coordinates and tracks delivery of required content with content owners for routine / maintenance submissions in all markets.
Maintain current regulatory knowledge and keep abreast of regulatory procedures and changes related to the electronic Common Technical Document.
Interprets, implements, and ensures compliance with relevant revised and new FDA/ICH/global eSubmission regulations.
Acts as a liaison between members of submissions and other functional areas in order to ensure timely submission of regulatory-compliant, quality documents.

Skills and Requirements

6 to 8+ years pharmaceutical and regulatory experience (biotech products preferred)
4 to 6+ years regulatory operations experience
SME in eCTD
SME in regulatory operations processes
Strong communication and project management abilities in global and virtual teams
Competent in the use of electronic document management and submissions publishing tools.
Flexibility, proactive, attention to detail, demonstrated accountability for deliverables, and proven ability to work independently is expected
Bachelor's Degree (life sciences preferable, IT/Business acceptable)

To Apply

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 contact Alex Czuprynski, alex@proclinical.com or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

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