Hired by Matrix, Inc. Direct Hire - Senior Associate, Report Publishing in Woodcliff Lake, New Jersey
Direct Hire - Senior Associate, Report Publishing
Job Location:Woodcliff Lake
Our Client, a human health care pharmaceutical company, is seeking a Senior Associate, Report Publishing possessing a good knowledge of report publishing processes and requirements in the global market place.
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.
Provide report publishing expertise and general back up support to the global Report Publishing group.
Provide expertise for RP in archiving and maintenance of departmental documentation.
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
RP process management
Ensures consistency of standards in systems and/ or processes in RP
Manage workflow processes to maximize the re-use of documents
Works with substantial independence and uses best practice
and knowledge to improve RPS deliverables
Act as report publishing super user and provide expertise to
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
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
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
Strong background knowledge of the various report types (e.g. DSUR, PSUR, IMPD, CSR, etc.) is a key requirement for success.
eCTD experience, bookmarking hyperlinking, utilizing ISI toolbox
SME's with templates and the ability to convert document to quick capture
Ability to communicate effective with various groups - CRO's, Reg Affairs, Med Affairs
Understanding of ICH guidelines
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
Please submit your resume for consideration. Once submitted, feel free to contact Amy at 201-226-3507 for additional information.
Approx. Duration: Perm
About Hired By Matrix
Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.
As the staffing industry evolves, Hired by Matrix continues to develop and grow. By combining our expertise with a keen understanding of each client’s needs we are able to source for the most qualified candidates. Our commitment to servicing our clients corresponds with our commitment to finding the perfect match between our clients and candidates and maintaining our relationships long term.
Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.Equal Opportunity EmployerWBENC CertifiedWOSB Certified*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.
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