Project/Program Manager

Overview

As an extended team member supporting the unique needs associated with a vaccine brand
and the required processes aligned with the Accelerated Approval status of the brand, the
Program Owner is tasked with the optimization, and execution of the operational processes and
procedures to ensure a compliant and timely submission of promotional materials to APLB.
This also involves working with Stakeholders on their needs and expectations while providing
input to Pre-submission team.

This position is responsible for, but not limited to the following:
Provide process/operational support, assistance with pre-CRT review prep and review,
reference information (pre-submission readiness) and other such items related to the brand
tactics. Included in that is the history and background on the brand why we are in the
Accelerated Approval FDA program and what that means to our promotional review and
submission process.
 Act as the conduit and triage prioritization questions and decisions engaging with Brand
and CAT points as requested by OPAR:
 Work with Brand team and all JOs to improve quality of submissions.  Pre-review
jobs at draft stage (before upload stage) prior to CRT review providing input for
items like DAP creation, template/sample set-up, metadata input, etc.
Work closely with JOs to make all the suggested corrections prior to passing along to CRT for
review.
 Track all new pre-submission jobs coming in and QC metadata to ensure proper
submission pathway
 Pre-CRT Check jobs for Accelerated Approval Tactics
 Manage, update, and generate new resources on the Brand Team
 Manage Pre-sub training decks on REACH
 POST APLB Process; Create and/or update deck for all Job Owners to follow for next
steps to achieve AFD. Assist JO with this process in 1:1's
 Acts as a resource to OPAR and sharing any updates to guidance from OPAR to Job
Owners.
 Acts as a resource to JO and CAT with ongoing assessment of current end-to-end
process:
 Train and onboard new team members, agencies and job owners on refresher
training on updated binder submission process and use of PromoMats
 Provide email communication on updates to brand guidance as needed (i.e.,
references, functional annotations, website access dates, email templates and
citations for unbranded references)

 Attend CRT Review and partner with Brand teams job owners for alignment on guidance
regarding the submissions process or job quality; provide notes on guidelines, rules or
reviewers guidance for each tactic.
 Attend Sprint Review and Sprint Planning sessions on digital engagement teams
 Liaise with Brand and pre-submission team to prioritize binders for OPAR review,
submission and final 2253 submissions. Assist pre-sub team in clarifying CRT review
comments during pre- sub readiness reviews.
 Attend all pre-submissions preparation prioritization meetings to ensure timeline
and relevant consideration of capacity across review processes (CRT) is
manageable
 Assist pre-submission team with any new tactics/updates/anomalies
 Through collaboration with the pre-submission team leads, assist in discussion of
binder jobs for APLB submission readiness at AFP (Approved For Production)
and PFFU (Pending Final Form Upload)

 Identify and inform team of any recommended enhancements of workflows in weekly
email communications

Required Experience and Skills:
 3-5+ years of relevant experience
 Knowledge of Veeva PromoMats, REACH, WorkFront
 Working knowledge of FDA Accelerated Approval Regulatory Requirements
 Working knowledge of Vaccines
 Knowledge of the Promotion Review Team process or general Medical Legal Review
processes
 Training and/or Onboarding of new colleagues
 Strong collaboration skills and proficient in building strong relationships with multiple
stakeholders.
 Experience working in a fast-paced, cross-functional environment
 Experience managing multiple stakeholders
 Experience working on multiple projects at one time
 Excellent interpersonal and communications skills (oral and written)
 Influence without authority (ability to manage up)
 Demonstrated ability to learn quickly

Preferred Experience and Skills:
 Background in Science with experience in Pharma and / or Operations related field
 Stakeholder Management Skills
 Communication, Planning, Project Management, Problem-Solving
 Ability to manage ambiguity and to adapt to changing needs of customers and business
 Agile knowledge
 Experience managing and coordinating with external suppliers

The target hiring compensation range for this role is $85,000 to $90,000. Compensation is based on several factors including, but not limited to education, relevant work experience, relevant certifications, and location. 

Additional benefits offered may include: medical health insurance and dental insurance, life insurance, and eligibility to participate in 401k plan with company match (if applicable).