Manager Regulatory Operations- Submission Sciences
Company: Biogen Idec
Location: Somerville
Posted on: January 12, 2021
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Job Description:
Job DescriptionThe Delivery Manager is responsible for the
coordination of all publishing deliverables, in line with the
strategic direction of their assigned programs/products. Acts as
the primary point of contact for regulatory functions (i.e. GEM,
CMC, Development, and Labelling) as appropriate in the products
lifecycle. Partners with planning and tracking to ensure submission
deliverables are incorporated and visible to all stakeholders.
Ensures hand offs and deliverables from authoring community are on
time and in line with the submission standards and expectations of
quality. Drives deliverable timelines with RSM and authoring
community and sets appropriate standards and expectations of
quality. Identifies and assesses impact of agency guidance updates
relevant to submission sciences, and drives innovative process
change for improved efficiency.Principal Accountabilities:Driving
change, responsibility for a wide range of initiatives /
relationships, as well as process efficiency / improvements.
Primary point of contact with vendor for all operational activities
(e.g., allocate and track publishing, GEM operational activities,
formats, templates, technical requirements).Oversee publishing
deliverables on a day to day basis to ensure successful execution
of operational activities for assigned productsCoordinates and
tracks delivery of required content with content owners for routine
/ maintenance submissions in all marketsAssist functional
leadership to --- analyzing and assess performance of
vendor-related activities against defined targets (e.g. collect and
measure KPIs, performance metrics data). Driving new concepts for
analyzing data / promoting awareness of Regulatory Information
Management strategies.Internal influencing, socializing and
communication of changes.Driver of quality of submission build, set
submission standards and ensure vendor compliance with
standards.Responsible for understanding and communicating impact of
Industry / Agency changes relevant to submission sciences, in
partnership with vendor and driving innovative process change for
improved efficiency.QualificationsBachelor---s Degree (life
sciences preferable, IT/Business acceptable)4 years pharmaceutical
and regulatory experience (biotech products preferred) with 2 to 4
years regulatory operations experience.Strong communication and
project management abilities in global and virtual teamsSME in
regulatory operations processesVendor management experience
beneficialSME in eCTDProject management qualification
preferableAdditional InformationPosition is based in Cambridge,
MA.SummaryType: Full-timeFunction: Quality Assurance
Keywords: Biogen Idec, Somerville , Manager Regulatory Operations- Submission Sciences, Executive , Somerville, Massachusetts
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