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Regulatory Publishing Specialist III
Ref No.: 18-02658
Location: Cambridge, Massachusetts
Position Type:Contract
Start Date / End Date: 05/07/2018 to 11/15/2018
Position Title: Regulatory Publishing Specialist III
Job Location: Cambridge, MA
Job Duration: 6 Months
   

Primary Duties
Provide a brief summary describing the major role, responsibility and purpose of the job. Summarize
key areas of accountability and budget responsibility, if applicable.
The Regulatory Publishing Specialist III is responsible for the planning, publishing (paper, NeES, eCTD), review and delivery of regulatory submissions to global Health Authorities within required timeframes. The primary accountability for this role is focused on the lifecycle submissions portfolio, but there is additional support for major/complex submissions. The Regulatory Publishing Specialist III also represents GRO in special initiatives, process design and validation testing of new and upgraded software.

Responsibilities
Describe the essential daily job functions and include % of time spent on each.
% of Time Job Function and Description
75%
  • Primarily responsible for the planning and publishing of the lifecycle submissions portfolio, with accountability of monitoring the submission forecast and ensuring timely submission of high quality, compliant and valid submissions to global health authorities within required timeframes.
  • Liaise with GRA and R&D authoring groups to ensure paper and electronic submission requirements and timelines are mutually understood and in line with corporate standards. Manage deliverable and submission timelines to ensure on-time delivery to regional markets.
  • Collaborate with GRO submission teams to ensure the submission portfolio is properly supported and work in a matrix environment to meet client's business needs.
  • Interpret regulatory guidelines to produce regulatory submission business requirements and ensure that those requirements are implemented internally.
  • Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues
  • Stay current with new electronic submission and regulatory documentation practices issued from global health authorities.
  • Define and implement regional and global processes for paper and electronic submission publishing, including the evaluation of current processes.
  • Provide Subject Matter Expertise for technical publishing tools and provide efficiency/enhancement proposals for the publishing tool suites.
  • Review R&D documents to ensure compliance with client's submission ready standards guidelines.
25%
  • Contribute to new and updated process and standards.
  • Participate in validation testing and requirements gathering of new and upgraded software.
  • Responsible for the accuracy of information for submission-related metrics for senior management.
  • Participate in GRA special initiatives.
Education and Experience Requirements
Include educational requirements or equivalency, required years and type(s) or experience, and
necessary licenses or certificates. Specify which are required and which are preferred. For UK,
please do not use years of experience due to UK Legislation
  • Bachelor's degree or equivalent work experience is required. Scientific and/or computer science field preferred.
  • 3-5 years of pharmaceutical experience in a global regulatory environment, including experience with document management technology and electronic publishing software (e.g. Documentum, FirstDocs, ISI Toolbox, eCTDXpress, etc.).
Key Skills, Abilities, and Competencies
Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be
made to enable individuals with disabilities to perform the essential functions.
  • Proficiency in publishing paper, NeES, and eCTD submissions and using related tools.
  • Strong understanding of global regulatory requirements and submission processes.
  • Understanding of Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines.
  • Applicable knowledge of the drug development process.
  • Proficiency working in MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required
Complexity and Problem Solving
Describe the decisions made by the incumbents on a regular basis. Include decisions within the
Incumbent's authority to make as well as those decisions that must be referred to a higher level.
  • Self-starter, who motivates, has tact, diplomacy, leadership skills and a flexible and positive approach.
  • Ability to identify and understand complex issues and propose creative and achievable solutions. Determines the causes and possible solutions to the problem.
  • Strong attention to detail and accuracy.
  • Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization.
  • Ability to cultivate internal and external relationships.
Internal and External Contacts
List contacts this job advises, consults, or coordinates with on a regular basis. Describe to whom the job is accountable. Indicate each Contact category (Internal, Vendor, Customer, or Other) and provide examples.
Internal (within GRA)
  • Global Regulatory Operations
  • Strategists
  • Labeling
External (across R&D)
  • client IT
  • Marketing Services
  • R&D and Tech Ops functions
Other Job Requirements
List any other job requirements, including travel, physical abilities required, etc.