PRAHS

2017-41562

- | US-MA-Boston
2 weeks ago
Title
Associate Director, Global Submission Management - Boston

Overview

Do you want to watch clinical development change, or do you want to be the one to shape it?

 

Because we’re hoping you’re here for the latter.

 

Who are we?

We Are PRA.

 

We are 13,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.

 

Who are you?

You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be an Associate Director, Global Submission Management, you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

 

Still here? Good. Because if this is you, we’d really like to meet you.

Responsibilities

What will you be doing?

 

As an  Associate Director, Global Submission Management, you will be responsible for the daily management and oversight of local/regional staff, as well as the personal and professional development of Global Submission Managers (GSMs). The Associate Director will be responsible for ensuring alignment with the core competencies of the GSM role, and for measurement of performance against functional goals and expectations.  The Associate Director retains flexibility to participate in projects as a GSM in addition to assuming leadership responsibilities for the GSMs at their site or region.  The Global Submission Manager (GSM) works effectively with global/regional cross functional teams to plan, monitor and deliver compliant regulatory submissions. The GSM introduces flexibility within and across therapeutic areas (development and marketed products) to provide broad regulatory submission support to ensure all submission and business deliverables are met in a timely manner. In collaboration with key members from global and local regulatory affairs, the GSM will compile and execute submission strategy plans for new marketing authorisations as well as submission strategies for the maintenance of existing drug licenses.

The GSM promotes a global e-working environment in collaboration with Submission and Information Management personnel (SIM), this includes regulatory systems, tools and e-submission expertise. The GSM strives to drive efficient, standardized best practices for regulatory submission documentation necessary for applications via the end-end submission model to approval, through product launch and beyond.  The GSM continually monitors, interprets and validates evolving agency submission standards/policies and assesses the potential impact to business process to ensure compliance and efficiency in the delivery of submissions.  The GSM contributes to solutions with respect to regulatory submission issues by ensuring potential risks are identified and mitigation plans are put in place. This position also contributes to continual process improvement and change management procedures and may coach other members of the GSM team.

The above will be carried out according to regulatory guidelines as well as PRA relevant SOPs. This position will also ensure that PRA is aware and responsive to external guidelines, regulations, changes in the marketplace and other information relating to global regulatory submission management.

 

The GSM will act in a manner befitting PRA core values.

 

  • Develops a ‘service minded and customer focused’ Global Submission Management team, maximizing the global capacity of the team to optimize partnership with global team members across multiple time zones and continuously monitoring customer satisfaction.
  • Demonstrates visionary leadership - drives continuous submission process improvements to enable efficient and effective submission planning and execution
  • Provides the GSM leadership team with subject matter expertise in order to build strategic and operational business models
  • Ensures the development of core competencies and measurement of performance against business and departmental goals and expectations
  • Builds strong relationships with key Regulatory submission stakeholders within the region or site
  • Maintains an environment that attracts, develops and retains high quality employees

 

Supervisory Responsibilities:

  • Support GSM Head with respect to planning, directing and overseeing the GSM operations and health of the group
  • Identify training opportunities and coach, mentor and develop staff, including overseeing new employee on boarding and providing career development opportunities in accordance with their role and responsibilities.
  • Manage and develop work systems, procedures, and policies that enable and encourage the optimum performance of local staff.
  • Partner with GSM Global Head to identify resourcing needs and appropriate allocation of GSMs to projects.
  • Work with Global Head of GSM and local Human Resources staff to select, interview, and employ an agreed number of employees.
  • Foster a spirit of teamwork and unity among SIM department members.

 

GSM Responsibilities:

  • Management of the cross-functional global submission teams in the delivery of compliant submission components according to agreed requirements, timelines and processes. This includes planning and co/hosting and presenting at ‘kick-off’ meetings and preparing appropriate materials to facilitate team discussion, timeline mapping and submission strategy.
  • Creation of standard project management tools such as submission risk, issue, escalation and communication plans (as appropriate) for larger/more complex submission types.
  • Identify appropriate submission KPIs in order to track project progress and present to cross functional submission teams.
  • Proficient in creating submission work breakdown structures and scheduling plans via the use of network diagrams and GANTT charts. This includes identifying and tracking critical path activities.
  • Firm understanding of submission deliverable dependencies and ability to reflect this in MS-Project in order to create and maintain detailed submission schedules as MS-Project tasks.
  • Conduct regular lessons learnt sessions to encourage process improvement and efficiencies within and across submission project teams.
  • Creation and maintenance of a submission forecast for functional/resource planning, in alignment with the Global Regulatory Plan.
  • Champion embedded processes and best practices within the global and local cross functional team in the creation of global submission ready documents and agrees and manages realistic dates for document handover in collaboration with the publishing group.
  • Facilitate the development of a global submission document plan (TOC) which specifies source submission content and tracks document creation through to approval and publishing. This includes familiarity with core dossier concepts and global document reusability.
  • Proactively escalates any timeline concerns, risks and issues that may impact the project and engages appropriate representatives to manage/mitigate outcomes.
  • Recognition of the internal and external interdependencies among submission activities that could have an impact to the schedule or quality of a submission and manage to ensure that submission goals are achieved on time and to the highest quality.
  • As a global submissions expert, ensures the project team has sufficient awareness and knowledge of e-submission principles and lifecycle management and understands, represents and communicates regional differences as appropriate within the context of global submission preparation.
  • Awareness of industry submission trends and ensuring changing policies and best practices are continually reflected in submission planning, monitoring and control.

Qualifications

What do you need to have?

 

Education:  Bachelor’s degree (or significant proven experience in a pharmaceutical environment)

Skills: 

  • Master knowledge of regulatory procedures and a wider understanding of patient safety and commercial registration status.
  • Expert working experience of CTA’s, INDs, orphan drug applications (ODA), CTD dossiers for MAAs, national submissions, MRP/DCP and centralized procedures. Including post marketing submissions such as variations, renewals, labeling etc.
  • Line Management experience
  • Proven experience working within Global Regulatory Affairs, Regulatory Operations





PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

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