Hired by Matrix, Inc. Direct Hire - Senior Associate, Report Publishing in Woodcliff Lake, New Jersey

Direct Hire - Senior Associate, Report Publishing

Job Type:Perm

Job Location:Woodcliff Lake

New Jersey

Job Description:

Job Summary

  • 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.

Key Deliverables

  • 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.

Responsibilities

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

  • 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

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

Qualifications

Education/Experience

  • 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.

Experience Required

  • 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

Skills

  • 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

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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