Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, 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 Manager, Regulatory Project Manager (RPM) is the RPM Lead for identified projects and can be assigned to a Regulatory Sub Team (RST) to project manage RST activities. When assigned to an RST, the Senior Manager, RPM is the operational strategic partner of the Global Regulatory Lead (GRL), the RPM RST Roles and Responsibilities (R&R) are outlined in the RST Playbook. When assigned to a major project the RPM Lead coordinates Submission Sub Team (SST) meetings and develops timelines to support regulatory filings. Creates and maintains the Submission Project Plan and Content Plan through cross functional project team discussions and, prepares timeline visuals highlighting the critical path to submission. The Senior Manager, RPM also supports the development and maintenance of RPM processes and tools
You will be responsible for:
As RPM Lead for identified projects, you will be responsible for:
Developing Timelines for preparation and submission of Global Regulatory Filings including initial INDs, responses to questions (RtQs), Briefing Packages, BLAs/ NDAs/ MAAs and maintenance submissions;
Creating and maintaining Submission Project Plans, Content Plans and Responsibility Matrices through cross functional discussions;
Proactively monitoring timelines for key program activities and tracking submission deliverables to maintain target submission dates;
Preparing the Regulatory Submission Timelines and Visual Overview, highlighting documents on a Critical Path;
Coordinating Submission Subteam (SST) meetings in conjunction with the GRL and Submission Leads, to discuss and align on activities, timelines, progress and resolution of issues;
Identifying potential issues that could impact the target submission date and lead cross functional discussions to reach consensus around a solution;
Providing a weekly/ monthly outlook on upcoming submission activities to Project Teams (deliverables and review timelines);
Oversight of Content Planning process;
Coordinating submission documents through the review cycles;
Managing overall completeness of the Content Plans I the applicable information management systems;
Cooridnating with the RegulatoryOperations (RegOps~) Lead on submission timelines and document status.
Managing Health Authority requests to ensure responses are submitted within the requested agency timeline while keeping relevant stakeholders in the loop.
Acting as the Point of Contact for Strategy, Program and Portfolio Management (SPPM) to ensure Regulatory Information in PLANIT is up to date and aligned within RA;
Providing RPM support to the RST aligned to RPMs R&R outlined in the RST Playbook;
Involved in regulatory submission process improvement activities and establishing repeatable processes utilizing key technologies, tools and processes;
Supporting the RPM team in setting standards to ensure alignment across programs;
Supporting the development of Project Management tools to be used by the wider GRA organization;
Supporting any other assigned RPM activities as directed by the head of RPM.
You will need to have:
A minimum of 5 years pharmaceutical or other related industry experience with 3+ years of direct Regulatory Project Management (project management) experience;
Strong verbal and written communication and presentation skills;
Strong project management, organizational and planning skills;
Strong interpersonal skills and ability to work effectively and build relationships with cross-functional teams;
Good understanding of submission deliverable dependencies and ability to reflect this in project plans in order to create and maintain detailed submission schedules (as MS-Project tasks), knowledge of One Pager Pro and/ or Office Timeline Pro is a plus;
In-depth understanding of the internal and external interdependencies among submission activities that could have an impact on the schedule or quality of a submission to ensure that submission goals are met in a timely manner and to the highest quality;
The ability to multi-task, pay close attention to detail, and follow projects through to completion to meet deadlines;
The ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities;
The ability to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in project timelines;
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; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
|Occupational Category||Senior Manager|
|Job Type||Full Time|
|Posted at||2023-05-26 3:43 am|