Senior Project Manager, Clinical Supply

AbbVie Inc.; North Chicago (IL); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a qualified professional to influence protocol design and packaging workflows for clinical supplies in a fast-paced environment. The role focuses on translating study designs into compliant labeling and logistics plans, coordinating with Third Party and QA teams to ensure supply readiness.

You will forecast needs, manage risks, and contribute to cross-functional initiatives while aligning with regulatory standards and project milestones.

Qualifications

• Bachelor’s Degree required in a physical science, math, engineering or pharmacy.
• 3 years total experience in pharmaceutical industry preferred.
• Experience in Drug Discovery/Development, Clinical Operations, Supply Chain or Quality Assurance.
• Ability to apply compliance in a regulated environment and improve processes.

Responsibilities

• Translate clinical study design into packaging design and labeling sections.
• Develop protocol specific labeling compliant with global regulations.
• Identify, plan and track timelines, activities, logistics and milestones.
• Create protocol specific manufacturing and packaging work orders with vendors and QA.
• Forecast protocol specific bulk drug product requirements and supplementary items.
• Collaborate across functions as a drug subject matter expert and lead improvement initiatives.

Skills

Strong problem solving

Project management

Communication skills

Cross-functional collaboration

Regulatory understanding

Education

Bachelor’s Degree

Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient ulizaon of supply chain resources. Translates clinical study design into packaging design. Authors the study medicaon and labeling secon of the clinical protocol. Develops protocol specific labeling compliant with applicable global regulaons. Idenfies, develops, communicates and tracks project melines, acvies, logiscs and milestones. Responsible for creang appropriate protocol specific manufacturing and packaging work orders in concert with Third Party and IRT vendors, quality assurance, clinical team partners, etc. to ensure myriad availability of clinical supplies. Responsible for protocol specific clinical supplies scenario analysis, risk management and conngency planning. Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies and commodies, including overages. Parcipates in cross funconal iniaves as drug subject maer expert. Leads in funcon improvement iniaves.

Qualifications

Bachelor’s Degree required, preferably in physical science, math, engineering or pharmacy. 3 years total experience in Pharmaceucal industry preferred, but not required. Must have experience in one of the following areas: Drug Discovery (e.g. Process Chemistry, Analycal Chemistry), Drug Development (e.g. formulaon), Clinical Operaons (e.g. Clinical Project Management), Supply Chain (e.g. Clinical Supplies Project Management), Quality Assurance. Proficient in the applicaon of standard business requirements (for example SOPs, Global Regulaons, OEC,). Must have understanding of importance of compliance in a regulated environment and be capable of applying this knowledge to improve current processes. Capable of represenng CDSM as parcipant in and contributor to cross funconal iniaves. Ability to work collaboravely across departments/funcons and interact in a tacul, professional and effecve manner. Ability to manage and priorize mulple tasks under ght deadlines and high pressure. Strong problem solving and Project Management skills. Strong communicaon skills (both wrien and oral).

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html