PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.
This position is responsible for supporting CSO Project management by enabling the on-time delivery of clinical supplies projects across the Client portfolio. This role is primarily responsible for supporting CSO Project Manager’s by developing and updating Study Supply Plans, managing various work streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.
1. Develops and updates Study Supply Plans in close communication with CSO project Managers.
2. Responsible for the Clinical Label Development process which includes creation of master label text, translations, and label proofs.
3. Manages CMO documentation reviews (i.e, packaging Batch Record) review and approval process with Quality Assurance and other CSO personnel.
4. Works closely with Quality Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.
5. Oversees clinical site and depot inventories through the course of a study and ensures alignment with supply forecast and study requirements. Reviews IRT specifications, participates in UAT as requested and maintains settings in IRT to align with supply plans.
6. Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.
7. Vendor Management –supports Person in Plant (PIP) activities when packaging operations for DSI are in-process. Supports investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to ship
8. Assists in the creation of SOP’s and work instructions specific to CSO Supply Planning as requested.
9. Responsible for updating relevant Trial Master Files (TMF) with CSO-related documents
10. Supports the CSO PM in executing additional operational and logistical duties as discussed and agreed to by management.
11. Acts as point of contact for operational clinical supply matters during the course of a clinical trial including facilitating the review of temperature excursions.
Grow your career within the project management ladder, or develop into a leader. These are just a few career pathways available once you choose to Be with PPD.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.
Join PPD in our relentless pursuit of excellence - apply now!
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities:
- Good understanding of Pharmaceutical Development, Quality Assurance, and Regulatory (domestic and international).
- Solid knowledge of clinical supply planning, manufacturing, packaging, and labeling.
- Experience in managing third-party contract clinical supply operations/CMO’s.
- Experience managing multiple vendors per project required.
- Import/export knowledge desirable.
- Working in a matrixed environment
- Excellent communication, negotiating, and computer skills.
- Strong team orientation.
- Experience with IRT highly preferred
- Excellent problem solving, judgment and decision-making skills
- Strong verbal, written and presentation skills
- Proven organizational and negotiation skills
- Extensive knowledge and proven leadership in project management
- Understanding of basic budgeting and forecasting terms and definitions
- Superior time management, planning, and organizational skills
- Full understanding of laboratory requirements, ICH guidelines, USP requirements and FDA guidance
- Ability to multitask and effectively prioritize workload
- Ability to work effectively with multi-level teams
- Ability to work in a fast-paced undefined environment
- Strong client relationship management skills
Working Conditions and Environment:
- Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
- Occasional drives to site locations, occasional domestic travel.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Exposure to fluctuating and/or extreme temperatures on rare occasions.
- Ability to work in an upright and /or stationary position for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
- Occasional mobility needed.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.