Job Description

A highly reputable biotechnology pharmaceutical corporation is currently hiring for a Clinical Supplies Manager to work in the greater San Francisco Bay area. 

SUMMARY:

• Clinical Supplies Manager will oversee all aspects of clinical supply management including packaging, labeling, monitor inventory levels, and distribution by interacting with internal and external supply partners/vendors to ensure supply of IMP are sufficient at depots and clinical sites.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Proactively drive the labeling, packaging, release, distribution of clinical supplies at external CMO’s for assigned studies, ensuring the project timeline is met or exceeded.
• Ensure domestic and global distribution arrangements are in place with external vendors to allow shipment following availability of technical and regulatory releases.
• In collaboration with relevant partners, create forecasts and packaging design based on study needs to ensure optimized supply plan.
• Partner with key stakeholders (including Quality Assurance and Regulatory Affairs) to ensure supplies are labelled and released for clinical site shipment for global clinical trials.
• Design and/or review label text to meet product requirements and ensure compliance with US and international regulations.
• Represent clinical supplies function at clinical trial team meetings; communicate plan and timelines to internal and external customers and partners.
• Utilize appropriate software and IT systems to effectively manage key project activities.

EDUCATION/EXPERIENCE/SKILLS: 

EDUCATION & EXPERIENCE :

• BS/BA degree in related discipline and at least three years of related experience OR MS/MA degree in related discipline and at least one year of related experience
• 7+ years of related experience and/or combination of education and experience
• Certification in assigned areas is a plus.

KNOWLEDGE/SKILLS/ABILITIES:

• Demonstrate experience with clinical supply management planning, labeling, packaging, and distribution.
• Willingness to work in a fast paced, evolving environment.
• Clinical Supply management experience using contract manufacturing companies strongly preferred.
• Knowledge of GMP batch record development, review, and approval processes. Knowledge of Interactive Voice/Web response systems for use in clinical studies.
• Working knowledge of regulations relating to clinical labeling, packaging and distribution activities.
• Working knowledge of GMP/GCP/GLP regulations required.
• Uses professional concepts and company objectives to resolve moderate to complex issues in creative and effective ways.
• Excellent project management and communication skills.

JOB COMPLEXITY:

• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
• Networks with key contacts outside own area of expertise.

Company Description

Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.