Initial responsibility will be to organize and assist the IgAN team and

Client DRA with Subpart H submission of IgAN materials.

Create a reference list (across all workstreams) of the materials brand

will need "in market for the first 121 days post-launch.

In preparation for when 2253 process is initiated, prioritize materials list

to ensure brand's key materials will be included in the initial batches

submitted to OPDP (websites, patient support materials, sales materials,

medical information, etc.)

-Develop timelines, materials, and communications that will track

according to DRA timelines (from FUSE approval/release to

appropriate Subpart H batch).

-In partnership with DRA, create reference materials, and

conduct training for internal and external agencies/partners

providing guidance for the submission of their content via

Subpart H (timing if batch submissions, required annotations,

etc.)

Support Client Atrasentan Launch Team Lead:

-Organize and spearhead Launch Readiness Meetings for IgAN

launch.

-Schedule LMT meetings including all relevant workstreams.

-Develop meeting agendas & facilitate meeting discussions.

-Provide documentation/minutes.

Help identify and mitigate identified risks that could potentially

impact launch.

-Develop timelines & finalize Day 1 Plan for the launch.

-Utilize knowledge and experience obtained when managing

IgAN SubpartH submissions to OPDP and apply this model to spearhead

the SubpartH submissions for IgAN


#LI-JV1