SENIOR SPECIALIST, REGULATORY PUBLISHING

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives.
At Alexion AstraZeneca Rare Disease, people living with rare and devastating diseases are our Guiding Star.
We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives.
We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is what you will do.
The Senior Specialist, Regulatory Publishing is accountable for managing and coordinating the publishing activities within GRO for routine and non-routine submission tasks including publishing, scheduling, submission compilation, QC, validation, dispatch and archiving of electronic and paper submissions (when needed) for company portfolio.
The Senior Specialist, Regulatory Publishing is responsible for publishing and preparation of high quality global submission dossiers, ensuring Alexion delivers compliant submissions to global health authorities within required timeframes.
The Senior Specialist, Regulatory Publishing, 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 Specialist, Regulatory Publishing, will also support the Submission Operations Lead and/or Submission Manager, in activities related to setting standards, best practices, KPI collection, developing new procedures and work instructions, lessons learned dissemination and will assist in other activities as needed.
It is expected that Sr.
Specialist, Regulatory Publishing, will be significantly involved in publishing activities and will also contribute to archiving activities.
You will be responsible for.
Publishes both routine (eg, CSRs, IBs, PSURs) and also more complicated publishing projects (eg, datasets, CRFs, regional documents) for eCTD, NeeS and paper submissions;  Compiles submissions and dispatches through Electronic submission gateways; Ensures acceptable format of documents received in Submission Operations;  Participates in compliant and timely archiving of regulatory submissions and correspondences for Alexion products;  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, regulatory submission project managers and publishers; Participates in cross-functional project teams to provide publishing strategies and timelines, As a global publishing expert, ensures the submission project team has sufficient awareness and knowledge on the application of e-submission (eCTD, NeeS, etc.) requirements and lifecycle management concepts and communicates regional differences (general formatting, template adherence, submission standards and procedures and version control) for their specific submission, within the context of global submission preparation; Assists with other Regulatory Operations activities.
You will need to have.
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 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 verbal and written communication and presentation skills.
Strong interpersonal skills and ability to work effectively and build relationships with cross-functional teams.
Self-motivated and results-oriented with high energy drive Knowledgeable of eCTD templates and structure of Modules (1-5) Strong knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (e.
.
ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools.
Solid experience and knowledge of SharePoint technology and RIM systems  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 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.
The duties of this role are generally conducted in an office environment.
As is typical of an office-based role, employees must be able, with or without an accommodation to.
use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
AstraZeneca embraces diversity and equality of opportunity.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be.
We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.