MakroCare | A MakroGroup Company |
MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region
MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)
Job Description & Responsibilities
This role will be responsible for supporting Clinical Supply Chain, by contributing to various work streams with key service providers and supporting special projects/continuous improvement initiatives as Every effort has been made to identify the essential functions of this However, the role is not limited to the duties highlighted to perform the
- Works closely with Clinical Supply Chain in the review, interpretation and implementation of supply forecast
- Participates in Clinical study team meetings where Clinical supply representation is
- Supports the clinical product label development process which includes the creation of master label text, translations, and label
- Coordinates the activities around temperature excursion management and disposition, to update impacted inventory in IRT and other related
- Supports investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to
- Oversees clinical site and depot inventories through the course of a study and ensures alignment with supply forecast and study
- Reviews IRT specifications, participate in UAT as requested and maintains settings in IRT to align with supply
- Write study-specific ancillary plan based on a review of equipment manuals, specifications, and certificates as well as make recommendations on global capabilities and strategy
- Supports IP training/information sharing of DEA Form 222 process inclusive of tracking of 222s and associated
- Responsible for updating relevant Trial Master Files (TMF) when
- Performs close-out activities including returned goods reconciliation, inventory destruction processing, and file ;
- Performs other duties as
Qualifications:
- Bachelor s degree or equivalent required (pref BTech/B Pharma/M Pharma - Life Science with MBA or Management background)
- Working knowledge of standard business software including MS Excel, PowerPoint and Project
- Highly motivated and organized individual with good communication skills
- Team player, able to work well in a group setting as well as independently in a fast-paced
- 4+ years of industry experience
- Prior experience in Clinical Supply Chain Management and ability to work cross-functionally with Clinical Operations, CMC, Quality and CMOs, to ensure seamless execution
- Experience interacting with and managing third-party operations like vendors, CMOs and logistics providers
- Experience with Interactive Response Technology (IRT) systems
- Knowledge of cGMP and other relevant FDA and EU Regulations
Skills :