August 20, 2016

Global Publishing Manager

Seqirus - Cambridge, MA

View Job Summary View Job Summary
  • Company
    Seqirus Seqirus
  • Location
    Cambridge, MA
  • Job Type
  • Job Classification
    Full Time
  • Experience
    Entry Level (0 - 2 years)
  • Company Ref #
  • AJE Ref #

Job Description

Job Purpose:

* The position is responsible for the timely publishing of Regional as well as Global work-sharing publishing tasks world-wide to maximize efficiency of global publishing resources.

* Drives optimization of publishing systems, publishing best practices and global submission standards in accordance with regulatory requirements world-wide and the implementation, maintenance and continuous improvement of publishing systems and processes striving for publishing excellence.

Major Accountabilities:

* Ensures timely creation of high quality submission packages (i.e. e-CTD, NEES, Paper) related to drugs under investigation, marketing authorization applications, lifecycle management applications, and post approval applications (e.g. NDA, BLA, IND, CTA, PSUR, Variations) in accordance with health authority requirements

* Supports major submissions across the sites in close co-operation with other Global Publishing Managers; discusses planned business critical filing and publishing timelines and addresses local capacity issues, as required

* Support the implementation and maintenance of global publishing systems (including system testing and validation) and processes

* Ensures close collaboration with the relevant stakeholders (e.g. regulatory specialist, regional/local regulatory colleagues, source document authors, etc.)

* Monitors regulatory bodies on regulatory publishing requirements and brings these new requirements to the attention of the Global Publishing Managers; supports the implementation of these new publishing requirements as needed

* In collaboration with the Global Regulatory Compliance Manager, generates and maintains training materials and SOPs/Work Instructions for GRA and authors of source documents and provides training, as required.

Minimum Requirements:

* A degree in computer information systems, life sciences or equivalent

* Previous experience in a regulatory operations role or related

* Familiarity with health authority dossier standards and requirements of the main markets (e.g. EU, US, AU) and ICH guidelines on CTD /eCTD requirements

* Understanding publishing practices and related issues

Preferred Qualifications/Experience:

* Previous direct experience in a regulatory publishing function

* Understanding of publishing systems and IT system validation and testing practices

Essential Skills, Knowledge & Attributes:

* Excellent planning, organizing and time management skills

* Excellent problem solving, attention to detail and customer service skills

* Ability to handle multiple projects simultaneously and prioritize work independently

* Ability to work in a matrix organization

* Ability to work with a multicultural group

* Ability to deal with rapid change

* Ability to work well under pressure

* Ability to build and maintain relationships across organizational boundaries with broad variety of stakeholders

* Computer literacy.

Seqirus is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.