Project Manager - Pharma

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 Job Owners (JOs), Agency and 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

tactics.

* Act as the conduit and triage prioritization questions and decisions engaging with

Brand and Agency points as requested by OPAR:

o 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 Brand Lead and specific JOs to make all the suggested

corrections prior to passing along to CRT for review.

* Track all new Presubmission jobs coming in and QC metadata to ensure proper

submission pathway.

* Acts as a resource to GMIS (Global Medical CRT Reviewers) with discussions on

approved references and their effect on tactics.

* Acts as a resource to JO and Agency with ongoing assessment of current end-to-

end process:

o Train and onboard new team members, agencies and provide JO

refresher training on updated pre-submission process and use of

PromoMats.

o 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 all teams.

* Liaise with Brand and pre-submission team to prioritize pre-submissions for

OPAR review, submission and final 2253 submissions. Assist pre-sub team in

clarifying CRT review comments during pre-sub readiness reviews.

* Attend any/all pre-submission 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

pre-submission 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.

* Track all new and updated references coming in on Gardasil 9 MS Teams Site

* Manage, update, and generate new resources on Brand Team Site for all users.

* Manage onboarding new Job Owners; disseminate welcome emails to all new

brand members detailing the access, links and information as they need to begin

their job.

* Back up review and Approval Reference Requests for Aquent Reference

Stewards and provide weekly email regarding Reference Requests.

Required Experience and Skills:

* 3-5+ years of relevant experience

* Knowledge of Veeva PromoMats, REACH and 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, 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 w/ experience in Pharma and/or Operations related field

* Stakeholder Management Skills

o 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.