Alexion Pharmaceuticals Senior Associate, Submission Operations in Boston, Massachusetts
The Senior Associate, Submission Operations, is accountable for managing the routine and non-routine submission activity for Alexion’s portfolio. The Senior Associate, Submission Operation, in collaboration with the Regulatory Lead, designs and executes high quality global submission plans, ensuring Alexion delivers compliant submissions to global health authorities within required timeframes. The Senior Associate Submission Operations, provides technical expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation and delivery of regulatory submissions, and will act as the primary point of contact for project and/or submission teams when significant planning effort and oversight is required. The Senior Associate Submission Operations, will also support the Submission Operations Lead and/or Submission Manager, in activities related to setting standards, best practices, KPIs collection, developing new procedures and work instructions, and lessons learned dissemination and will assist in other activities as needed. It is expected that Sr Associate Submission Operations, will be significantly involved in publishing activities and will also contribute to archiving activities of the Group.
Provides operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications (IND, BLA, MAA, etc.), updates, amendments, and variations to global regulatory agencies.
Monitors the development of new regulatory requirements or guidances, and provides advice to Global Regulatory Operations and product teams of the impact on the business.
Involved in development and implementation of standards for dossier management, publishing, archiving and submission process for global regulatory authorities
Participates in validation activities for the implementation of electronic Regulatory Document Management systems
Participates in compliant and timely archiving of regulatory submissions and correspondences for Alexion products
Involved in regulatory submission process improvements activities and establishing repeatable processes utilizing key technologies, tools and processes
Manages the activities related to obtaining CPPs and other similar certificates
Responsible for management of the cross-functional global submission teams in the delivery of compliant submission components according to agreed standards, requirements, timelines and processes. This includes planning and presenting at project ‘kick-off’ meetings and preparing appropriate materials to facilitate team discussion, timeline mapping and submission strategy.
Participates and shares lessons learnt sessions to encourage process improvement and efficiencies within and across submission project teams.
Negotiates and agrees on realistic dates for document handoffs in collaboration with the authors and publishers.
Performs publishing and dossier compilation of routine and non-routine eCTD and other submissions, as needed (and as assigned)
In collaboration with the regulatory lead, manages the development and maintenance of a global submission content map, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval and publishing.
As a global submissions expert, ensures the project team has sufficient awareness and knowledge of e-submissions (eCTD, NeeS, etc.) and lifecycle management concepts and communicates regional differences as appropriate within the context of global submission preparation.
Assists the Submission Operations Lead in updating and disseminating the Global Submission Planner and Tracker information.
A minimum of 4 years of experience in regulatory affairs/operations within the pharmaceutical industry.
Strong verbal and written communication and presentation skills. A strong training skill is a plus.
Strong interpersonal skills and ability to work effectively and build relationships with cross- functional teams.
Self-motivated and results-oriented with high energy drive
Very knowledgeable in CTD/eCTD structure and requirements and a good understanding of submission requirements for global submission types (e.g. IND, BLA, MAA, NDS, CTA, PSUR etc.).
Solid experience in publishing and compilation of eCTD submissions for US and EU filings is required and experience publishing electronic submissions in other regions is desirable.
Strong knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (e.g. ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools. Solid experience and knowledge of SharePoint technology is desired.
In-depth knowledge of StartingPoint templates.
Demonstrated project management, organizational and planning skills.
Ability to multi-task, pay close attention to detail, and follow projects through to completion to meet deadlines.
Ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities.
Must be able to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines.
Good understanding of submission deliverable dependencies and ability to reflect this in project plan in order to create and maintain detailed submission schedules (as MS-Project tasks).
Good understanding of the internal and external interdependencies among submission activities that could have an impact on the schedule or quality of a submission and manage to ensure that submission goals are met on a timely manner and to the highest quality.
Experience with core dossier concepts and global document reusability is desirable.
Prior publishing and archiving experience is highly desirable and preferred
A minimum of a Bachelor’s degree in a scientific or technical discipline is required; equivalent experience may be accepted.
A minimum of 4 years pharmaceutical or other related industry experience with 1-3 years of regulatory submission management experience
Excellent experience and familiarity with electronic publishing (eCTD) software, Regulatory Information Management, and content/document management tools.
Familiarity with submission and drug/biologic development dossier concepts;
A firm grasp and understanding of the global eCTD.
Good organizational and project management skills.
Good knowledge of quality control procedures and methods related to processing of electronic and paper submissions, when needed.
Solid experience in the organization and management of electronic (and paper) archival file records for correspondence with regulatory agencies, formal submissions, etc.
Great interest and ability for training
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer