Shire Senior Submissions Specialist in Cambridge, Massachusetts

The Regulatory Senior Submission Specialist 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 Submissions Sr. Specialist also represents GRO in special initiatives, process design and validation testing of new and upgraded software.

Responsibilities

% 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 Shire’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 Shire’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

  • 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

  • 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

  • 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

Internal (within GRA)

  • Global Regulatory Operations

  • Strategists

  • Labeling

External (across R&D)

  • Shire IT

  • Marketing Services

  • R&D and Tech Ops functions

Other Job Requirements

  • Domestic and international travel may be required for this position.

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 Shire’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 Shire’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.

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

  • 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

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.