OCATION: Berkeley Heights, NJ and Wayne, NJ (2 positions total)
REQ. SKILLS: Electronic Submission Specialist (Global Regulatory Operations)- eCTD
Notes: Reviewed Nader and Asif, did not think they would be a good fit for this role based on their background. Emphasized communication skills are very important – will be openly communicating with Reg Ops team daily and resume should indicate they’ve done this in the past. Want someone who can hit the ground running with subs, will be trained briefly on the in-house publishing tool eSub livelink, if they have eCTD/electronic doc management systems background should have no trouble getting up to speed. Strong technical background. Comfortable/experienced working in a very busy environment with prior history of hands-on publishing tools experience to generate submissions. Head manager stated they pulled a lot of strings to get us on the list so she expects we will provide good people to her team quickly with a targeted start date of 7/15.
Responsibilities will include, but are not limited to, the following:
- Support Regulatory Affairs personnel in the coordination, preparation, and submission of all INDS/NDAs/MAAs and life cycle management of these submissions in both paper and electronic format.
- Responsible for the creation and compilation of quality Regulatory submissions and lifecycle management submissions. Planning, preparing, tracking, and archiving regulatory documents and submissions.
- Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including MAAs/NDAs, INDs, 510(k)s, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc.
- Responsible for maintenance of all Regulatory and FDA correspondence (distributing, and archiving into electronic document management system) within specified time frames.
- Verification of regulated documents via workflows within client’s electronic document management system (eSub livelink).
- Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
- Liaise with functional source areas (clinical, nonclinical, cmc, regulatory) to ensure documents are compliant with authoring style guide. “Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications”
- Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
- Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
- Close interaction with authoring community to track availability of deliverables.
- Other responsibilities related to the above within client as a whole, as assigned.
- 2 yrs. pharmaceutical industry experience, prior Regulatory Operations experience required
- Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic
- Knowledge of industry trends regarding electronic submissions
- Technical knowledge of electronic publishing systems and software
- Proficiency with MS-Office Suite and Adobe Acrobat applications
- Knowledge of health authority procedures/guidance’s regarding electronic submissions
- Knowledge of Electronic Document Management Systems
- Ability to balance multiple tasks to meet priorities and timelines
- Self-starter with superior time management skills, and ability to work independently or in teams
- Strong attention to detail
START DATE: 7/15/2013 – wants to have people in and ready to go by that date; expects we can have her people by early next week to review/interview
INTERVIEW: phone screen; poss. face-to-face/Skype
DURATION: 6-12 months +