Kelly Services Sr Global Submissions Specialist in Cambridge, Massachusetts
Sr. Global Submissions Specialist in Cambridge, MA
(9 month W2 contract)
Kelly Services is currently seeking a Sr. Global Submissions Specialist for one of our top clients in Cambridge, MA.
As a Sr. Global Submissions Specialists placed with Kelly Services, you The Global Submission Manager (GSM) is accountable for the timely delivery of compliant global submissions. The position promotes a global e-working environment and drives efficient, standardized best practices for regulatory submission document management. Assigned to a specific global project and partnering with the Global Regulatory Lead, as manager of cross-functional submission team, will plan and manage regulatory submissions and author and execute submission strategy to introduce efficiencies by promoting re-use of documents, adopting global dossier principles and standardizing processes to enable simultaneous compilation and publication of submissions.
Additional Job Responsibilities:
• Oversee the local GSMs but with strong emphasis on global team identity and continuity in project team support. • Identify training opportunities and provide mentoring to ensure GSMs are appropriately developed in accordance with their role and responsibilities. • Manage, develop and ensure strong performance of staff. • Partner with GSM Global Lead to identify resourcing needs and appropriate allocation of GSMs to projects. • Responsible for ensuring appropriate GSM support on given projects. • Manage the cross-functional submission team in the delivery of compliant submission components according to agreed timelines and processes. • Leads a global/local publishing team to coordinate timely, compliant submissions, prepared for global regulatory agencies, in accordance with the worldwide regulatory submission plan. • Sets the submission publishing strategy, including timelines and resource projections according to submission type. • Maintains a 2 year submission projection for functional planning, in alignment with the Global Regulatory Strategy Plan. • Ensures the publishing strategy maximizes document re-use and introduces efficiencies and learnings from other project and accounts for other planned registration activities. • Plans and manages detailed submission timelines as MS-Project schedules • Liaises with global and local cross functional areas in the creation of global submission ready documents and agrees dates for document handover • Develops a global submission tracker which specifies source submission content and tracks document approval and publishing progress against the overall submission table of contents. • Proactively raises any timeline concerns, risks and issues that may delay/impact the project and engages appropriate representatives to manage outcomes. • Understands the interdependencies among activities on a submission that could have an impact on 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 understanding of eCTD principles and lifecycle management and understands, represents and communicates regional differences as appropriate within the context of global submission preparation. • Provides recommendation for formatting standards and granularity of submission documents. • May support the GRL in the entry of specific data in the registration tracking system. • May be assigned to other types of non-submission projects for e.g. name change projects.
• Bachelor’s degree • Extensive experience working within Regulatory Operations environment and fluent understanding of submissions publishing process and requirements • Comprehensive document management experience • Extensive experience of working within Regulatory and/or Regulatory Operations in a pharmaceutical industry experience • Modest first line management experience • Experience in prioritizing own and others workload • Proven experience in developing and implementing novel technological solutions or new processes and leading the implementation of change • Qualified project management experience • Fluent with the drug development process and evidence of working with Regulatory Agencies supporting regulatory dossier submission, review and approval processes • Experience in leading cross-functional teams within a matrix environment • Solid understanding of document management systems and concepts • Experience of multitasking in a dead-lined controlled and highly regulated environment • Master’s Degree • Experience of introducing new systems and procedures based on interpretation and application of regulatory agency guidance documents and mandated legislation such as eCTD. • Is fluent with drug development and regulatory submission process • Our Client’s Operations - understands (or capable of understanding) the company’s operating structure and methods including a good knowledge of the parent company
With Kelly®, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 99 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies Career guides, information and tools to help you successfully position yourself throughout every stage of your career Access to more than 3,000 online training courses through our Kelly Learning Center Weekly pay and service bonus plans Group- rate insurance options available immediately upon hire*
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place.
Let Kelly fuel your career—connect with us today.
*Available for purchase and administered by a designated third-party vendor
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, and Gender Identity, and is committed to employing a diverse workforce.
Why Kelly®? With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
About Kelly Services®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.]]