MAA Submission Project Manager
- Employer
- Barrington James
- Location
- Remote working - no travel required
- Salary
- Competitive Rate
- Start date
- 1 Mar 2021
- Closing date
- 31 Mar 2021
View more
- Discipline
- Project Management, Regulatory Project Management
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
I am currently supporting a BioPharma Consultancy who specialises in CMC development, GMP Manufacturing, Regulatory Affairs, Quality Assurance and CDMO Search and Management. My Client is seeking a MAA Submission Project Manager to work with them on freelance basis for at least 12 months with a full FTE. This Consultant is required immediately and will be supporting a cross-functional MAA Submission team lead by the Client. This position is fully remote working and has no travel required.
Responsibilities include:
- Will partner with the Clients submissions team leader to manage business deliverables associated with the MAA submission and ensure compliance and on-time delivery of the agreed tasks according to the plan
- Will be accountable for developing and maintaining overall project timelines and MAA submission plans, monitoring and tracking team progress with the MAA documents and deliverables
- Will be facilitating team and sub-team meetings, and ensuring communication within the team ensuring results-oriented meetings and positive team dynamics – including sending out agendas and minutes on a timely basis
- Needs to communicate effectively with team members, senior leaders, and key stakeholders on assigned program/task progress, issues, risks and mitigation plans
- Builds and maintains a positive and dynamic working relationship with the submissions team leader, team members, other external stakeholders, and especially the client
- Applies project management expertise and methodologies based on world-class program management combined with regulatory expertise and experience
- Shall organize and channel all communication for maximum efficiency, full transparency, and positive team dynamics
- Shall organize and maintain all MAA documentation current and available for all team members
- Prepare regular updates, status reports and metrics for the MAA submission project for submission team, leadership and client
Requirements:
- BSc or MSc in Science or Pharmacy
- Project Management education and certification such as CPM, PPM, MPM
- 10+ years pharmaceutical regulatory affairs experience in the pharmaceutical industry, regulatory agency or consulting company
- 5+ years of previous IND/IMPD, BLA, NDA, and MAA submission experience
- Previous MAA and other submission Project Management experience
- Good understanding of regulatory guidance as pertaining to MAA submissions
- Desirable: good understanding of eCTD and submission publishing
I specialise in recruiting Regulatory Affairs professionals throughout Europe, if you would like to speak to me regarding the above position then please call me today on +44 (0)1293 77 66 44 for a confidential discussion.
Alternatively you can reach me on Linked In or e-mail me on JASmith@barringtonjames.com.
If you are interested in discussing any of my other vacancies, or simply want to be made aware of opportunities as they arise then please contact me or have a look at available jobs on the Barrington James Website.
I look forward to hearing from you soon!
Jasmine Smith
Contract Consultant ~ Regulatory Affairs
+ 44 (0)1293 77 66 44
Company
We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.
Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB
Get job alerts
Create a job alert and receive personalised job recommendations straight to your inbox.
Create alert