Document Management Specialist, Regulatory Support - Cambridge, MA | Biospace
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Document Management Specialist, Regulatory Support

Voisin Consulting Life Sciences

Location:
Cambridge, MA
Posted Date:
2/6/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Other
Areas of Expertise Desired:
Biotechnology, Pharmaceutical, Regulatory,

Job Description


Voisin Consulting Life Sciences (VCLS) assists Biotech, Pharma and Medtech manufacturers to develop, register and launch innovative products in North America and Europe. VCLS supports innovative life sciences companies throughout product development, from the design of global development and regulatory strategies, to their implementation and submissions to regulatory agencies and payers.

A team of 130 professionals in Europe (London, UK; Paris & Rennes, France; Lausanne, Switzerland), the USA (Cambridge, MA; Somerville, NJ, San Francisco, CA & Miami, FL), and Bangalore, India, offers numerous career opportunities both to healthcare product developers and support staff.

Our team is our greatest asset. VCLS is constantly looking for talented and motivated people, attracted by the very dynamic work environment of a fast-expanding truly international company.

Responsibilities:
Working in close collaboration with the Global Publishing team and Project teams to provide the following support:

•   Assist in preparation of important deliverables:
1.   Format MS Word documents;
2.   Create eCTD compliant PDFs;
3.   Publish electronic applications;
4.   Dispatch of electronic and CD/paper submissions to Regulatory Agencies (INDs, NDAs, BLAs, MAAs etc.);
•   Document management: filing, archiving;
•   Regularly provide up to date status reports to the Head of Publishing and Project Managers and maintain submission trackers as required;
•   Ensure regulatory submissions are published in accordance with the relevant ICH guidelines and maintain familiarity with ICH and regional eCTD requirements;
•   Ensure quality and timeliness of Client deliverables and submissions;
•   Contribute to Regulatory Intelligence and knowledge sharing within VCLS.

Requirements


•   A good working knowledge of electronic submission production tools, preferably
docuBridge, with 2 or more years of experience in a publishing role.
•   Excellent/advanced MS Office and Adobe Acrobat skills;
•   Knowledge of Document Management System, preferably Sharepoint;
•   Experience with File Transfer Portals (FTPs);
•   Experience with submissions via an Agency portal, i.e. any of the following: FDA’s    ESG, EMA Gateway, CESP;
•   Good understanding of ICH and regional eCTD requirements;
•   Experience in the pharmaceutical industry, or biotech or CRO or Consulting firm.

Personal attributes and skills:

•   Ability to manage multiple projects simultaneously;
•   Excellent communication skills and team player;
•   High motivation and flexibility;
•   Ability to work in a multicultural environment.


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