Company: Pharmalink Consulting
Location: Sandwich, Kent
Closing Date: 10 Nov 16
Salary (£): Competitive
Genpact Pharmlink is a highly specialized Regulatory Affairs Consultancy with a successful history. We have grown and developed our service offering through building relationships, listening to our clients’ needs and adapting our ways of working to meet the changing needs of regulatory markets around the world. It is this flexibility and adaptability that we look for in all of our Consultants.
Location: Sandwich, Kent, UK
Fixed Term Contract: 2 years
The Submissions Publisher performs assigned publishing activities in support of the Regulatory Operations\Affairs function. Supports submissions publishing and document preparation activities for functional areas (Regulatory, CMC and Clinical). This role will be responsible for the timely preparation of component documents and the compilation of submissions for original applications and marketed product life-cycle management. They will produce electronic and paper regulatory submissions in accordance with defined global and local standards, and ensures the timely creation submissions by working with other operational team members. May participate on small or large submission projects and must demonstrate the ability to work independently and manage multiple simultaneous submission activities.
Summary of Key Responsibilities: •Submission compilation/publishing of paper, hybrid and fully electronic submissions: review, assembly and publishing of submission documents through HA dispatch.Can include pre-IND/NDA/MAA submissions, original IND/NDA/MAAs and life-cycle sequences (including Annual Reports, Amendments, and Supplements) as well as Clinical Study Reports
•Performs submission build activities, including, but not limited to, ensuring submissions are built with submission-ready documents, creating inter-document links, performing quality check and validating compiled submissions, and finalizing submission by required dispatch date.
•Will review documents for submission-readiness and conformity to FDA regulations and guidelines.
•May provide formatting support for documents to ensure consistency within and between documents and with document templates.
•Adherence to governmental regulations, company SOPs, local working instructions and role specific training relevant to Regulatory Operations.
Training & Education Preferred: •BS or BA (preferable science or systems background) with submissions publishing experience and/or document management, or equivalent technical experience.
•Minimum of 3-5 years’ experience working within the pharmaceutical industry (Biotech, pharmaceutical or clinical research organization)
Prior Experience Preferred: •Knowledge of the Drug Development Process.
•Knowledge of global regulatory requirements with a strong focus on US, EU, ICH requirements
•Solid experience with document management and electronic publishing systems
•Solid experience with electronic filing submissions (eCTD) is required (Experience with both paper and electronic submissions preferable).
•Ability to manipulate large and complex documents required for submissions.
•Good interpersonal, communication, organizational and follow-up skills.
•Demonstrated personal initiative, responsibility and flexibility.
•Ability to work under limited supervision
•Ability to work under pressure and meet critical deadlines;
•Attention to detail with the ability to manage multiple projects.
Desired Skills and Abilities: •Solid experience with submission publishing tools (e.g. Liquent, Extedo, eCTD Express) and document management systems
•High level of expertise in Microsoft Suite of products (required), Adobe (required) and ISI Toolbox (preferable).
Vanwall Business Park
|Tel:||+44 (0) 1628 860300|
|Fax:||+44 (0) 1628 860400|
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