PRA Health Sciences Director, Global Publishing and Submission Support - Boston, MA or Deerfield, IL in Boston, Massachusetts

Job Description

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 a Director Publishing and Submission Support, 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 a Director Publishing and Submission Support, you will be an experienced Regulatory Operations professional with strong leadership, clear vision, practised at setting global strategies and demonstrated ability to lead, motivate and drive high performing global teams to exceed delivery and efficiency targets.

Fluent with end to end submission life cycle management in a pharmaceutical setting, this leader will be expert in translating regulatory dossier requirements for global submission types and experienced in managing these multiple agency requirements to achieve global simultaneous submissions for initial applications and post-approval dossiers worldwide.

With expert awareness of the current vendor landscape as it pertains to Regulatory document management and publishing applications, this leader will have a proven track record of leveraging such tools to drive business efficiencies and consistent delivery in the Regulatory publishing arena.

As a highly experienced manager of diversely talented and geographically distributed regulatory publishing staff, this role will have a strong focus on performance management, enabling delivery of a customer-centric service, as well as adherence to exceptional compliance and quality standards.

As a member of the Submissions and Information Management Leadership team, this role will set global budgets, manage workload forecasting, resource balancing and ensure optimal utilisation across one or more clients. Being practiced at creating and working with KPIs in the Regulatory publishing sector, this role will suit an individual who thrives in an environment of continuous improvement and change.

  • Enables effective relationships with external publishing vendors/contractors and software providers as appropriate to facilitate effective processing of the Regulatory submission workload and fit for purpose solutions
  • Establishes and assures adherence to budgets, schedules, work plans and performance requirements (KPIs).
  • Makes decisions on administrative and operational matters and ensures the publishing team effectively achieves its objectives
  • Contributes to the development and deployment of strategic solutions for the optimal capture, storage and workflow of all regulatory documents, contributing components and processes to ensure dossier delivery, submission publication, and regulatory submission filings
  • Maintains fluency with regulatory agency submission publishing and validation standards to ensure compliant, valid dossiers in core regions and emerging markets
  • Ensures the creation of processes and formatting requirements to support all submission types to meet the diverse business needs of multiple clients; promotes a culture of document re-use where appropriate.
  • Promotes partnerships with Project/Program Teams to ensure that the company meets all key submission milestones. Provides leadership and change management for full implementation of the eCTD (Electronic Common Technical Document) and worldwide e-submission filings.
  • Drives the submission process; creates and supports the electronic management of regulatory submissions from clinical trial application (IND, CTA) to marketing approval (NDA, MAA).
  • Accountable for setting global publishing strategies and supervises logistics for the effective preparation, quality assurance, and delivery of valid regulatory submissions in accordance with Regulatory agency requirements, company standards, and timelines
  • Responsible for maintaining and strategies for improving Regulatory Affairs systems/processes for the efficient publishing and archiving of regulatory submissions
  • Oversees the collaboration with Regulatory Affairs and contributing functional areas to create submission project plans as well as identify and allocate internal and external resources (including vendors/CROs).
  • As a representative of PRA, interacts with internal and external executive management requiring skillful negotiations of complex matters to influence decisions or authority guidance
  • Resolves significant conflicts and disputes within and/or across departments.
  • Negotiates win/win scenarios for organizational productivity and efficiency
  • Analyzes trends and evaluates the impact of changes in Regulatory Agency requirements for e-submissions; communicates changes to appropriate areas and implements required changes to submission filings to ensure compliance with required standards.
  • Ensures appropriate development and training programs according to Regulatory and submission project team needs or individuals development needs

  • As global leader of Publishing and Submission Support, responsible for the personal and professional development of the professionals based in London, Deerfield and Cambridge and adheres to performance management processes, respecting local requirements.
  • Facilitates recruitment, and is responsible for the coaching/mentoring, development, retention and performance reviews of direct reports
  • Sets team strategy and ensures alignment with SIM, GRA, PRA vision and goals
  • Prepare and monitor budgets for the group as appropriate.
  • Active member of SIM Leadership Team

Environmental Awareness
  • Is globally aware of changes to relevant agency guidelines / regulations and assesses impact to company systems / existing business processes; is accountable for inputting to related decision making/strategy and delivery of any associated business process change
  • Maintain an expert, current knowledge of GxP, Annex 11 and 21 CFR Part 11 validated systems
  • Represent PRA at relevant Industry Forums or End User/Software user groups
  • Maintain appropriate professional memberships e.g. TOPRA, DIA

Qualifications: What do you need to have?

Education: Bachelor's degree and 10+ years pharmaceutical experience
  • A minimum of 10 years leadership/management experience may be required with demonstrable experience of remote management in a global setting
  • A minimum of 8 years hands-on Regulatory Affairs/Operations experience and knowledge of pharmaceutical regulatory submission requirements for global filings (FDA and/or EMA, etc.) is required.
  • Extensive knowledge of European, US and international pharmaceutical regulations, guidelines, legislation in the context of Regulatory Submissions
  • Proven extensive experience of managing multiple customer interfaces and ensuring customer satisfaction
  • Demonstrated global leadership experience of setting effective global strategies and vision to deliver business objectives
  • Proven ability to manage the professional development of resources in a global pharmaceutical setting
  • Significant experience managing and implementing projects
  • Demonstrated experience of setting data quality standards and KPIs and measuring/reporting/improving compliance
  • Extensive experience of direct and matrix management of resources with operational responsibilities across disciplines and across multiple regions/countries
  • Expert awareness of regulatory publishing and electronic document management systems
  • Previous experience of interacting and operating within an industry forum and influencing the external environment
  • Extensive experience of delivering/overseeing/evolving user facing publishing services
  • Significant experience in prioritizing own and others workload in a global setting and managing good/poor performance
  • Strong skills in written and verbal communication (English)
  • Experience of setting and overseeing effective training programs and monitoring compliance
  • Experience in the maintenance of GxP, Annex 11 and 21 CFR Part 11 computerized systems
  • Advanced IT skills
  • Team player with excellent interpersonal skills
  • Self motivated and ability to work autonomously and within a team
  • Confidence interacting with all levels of management
  • Flexible - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.
  • Communication - ability to express oneself clearly and concisely to a variety of audiences

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

Company Description Health Sciences is seeking the best and brightest, nothing less will do. Who we are: We are 11,000 employees operating in 85 countries committed to saving lives, operating in unison. We are the best at what we do and always strive to be better. We are subject matter and therapeutic experts and each realize that every big change in history has begun with a single step. The impact is real and significant, we see it every day. We are making a difference and bringing lifesaving drugs to market faster than ever before and getting them into the hands of the men, women and children who need them. When there is a team of 11,000 moving forward together with a common goal, given the support, tools and technology needed, that single step becomes a movement. Interested? Come join the movement and discover YOUR PRA. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities