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Job opening for Direct Hire - Senior Associate, Report Publishing in Woodcliff Lake, NJ
Ref No.: 18-25399
Location: Woodcliff Lake, New Jersey
Start Date / End Date: 05/21/2018 to 08/20/2018
Job Title: Senior Associate, Report Publishing
Location: Woodcliff Lake, NJ
Duration: Permanent

Job Description:  

The Senior Associate, Report Publishing position is expected to have a good knowledge of report publishing processes and requirements in the global market place. Strong background knowledge of the various report types (e.g. DSUR, PSUR, IMPD, CSR, etc.) is a key requirement for success. The senior associate is also required to act as an SME for report publishing processes and systems while maintaining accountability for high quality output.
Communication, attention to detail, and time management are some of the skills that the senior associate will utilize on a daily basis.
Key Deliverables:
1. Provide report publishing expertise and general back up support to the global Report Publishing group.
2. Provide expertise for RP in archiving and maintenance of departmental documentation.
Responsibilities
1. RP global report publishing activities
·         Manages complex report publishing projects
·         Ensures availability of submission-ready documents in appropriate quality for lifecycle submissions
·         Uses specialist knowledge, analytical skills, judgment and broad conceptual and practical experience to solve complex problems and to contribute to process improvements within RPS
·         Interact with our strategic partners for publishing
·         Communicate processes, timelines, and document standards to document authors
·         Support execution of regulatory report publishing strategy under mentorship and direction of manager
2. RP process management
·         Ensures consistency of standards in systems and/ or processes in RP
·         Manage workflow processes to maximize the re-use of documents across dossiers
·         Works with substantial independence and uses best practice and knowledge to improve RPS deliverables
·         Act as report publishing super user and provide expertise to colleagues
3. Back-up assistance as required by RP global publishing team
·         File preparation and trouble-shooting during report publishing activities as power user
·         Maintenance of RP electronic archive
·         Provide technical training on the report publishing process as needed to key functions as instructed by manager
4. Provide cross functional support
·         Collaborate with various cross functional stakeholders in the generation and maintenance of SOPs, work instructions, templates and training materials
·         Provide back-up submission level publishing for critical path submissions as required
Job Qualifications
- BS (Life Science or related discipline) with minimum 3 years of industry experience, or BA with minimum 5 years of report publishing experience in pharma industry
- Excellent knowledge of written and spoken English
- Good knowledge (or capability) of electronic software programs and processes applied by Regulatory Operations as well as key processes of Regulatory Affairs
- In-depth understanding of ICH guidelines and eCTD submissions
- Excellent working knowledge of Word, Excel and PowerPoint software
- High attention to detail, strong organizational/project management skills, work independently, self-motivated and proactive
- Strong customer focus
- Strong communication skills
- Strategic thinker
Must haves:
1. eCTD experience, bookmarking hyperlinking, utilizing ISI toolbox
2. SME's with templates and the ability to convert document to quick capture
3. Ability to communicate effective with various groups - CRO's, Reg Affairs, Med Affairs
4. Understanding of ICH guidelines

Interested candidates can send their updated resumes on mayank.sharma1@artechinfo.com and you can also reach me at 973-967-3431.