CMC Project Manager
Description :
• Bachelor’s degree in life sciences or related scientific discipline. 
• Sound knowledge of worldwide CMC regulatory requirements for biopharmaceutical products.
• Detailed knowledge of biopharmaceutical drug development and manufacturing/supply processes.
• Minimum of 5 years’ experience in pharmaceutical or biotechnology drug development, with direct involvement in CMC-related activities and functions

·         Experience in CMC regulatory affairs is preferable. 
• Experience with biopharmaceutical products (e.g., monoclonal antibodies and therapeutic proteins) is preferable.
• Ability to manage and lead multiple projects/teams simultaneously.
• Global CMC Regulatory experience with biopharmaceuticals (e.g., monoclonal antibodies and therapeutic proteins).
• Continued professional growth in global regulatory affairs, including communication of evolving trends and policies.
• Broad knowledge base of regulatory functions to understand wider implications of emerging issues across projects.
• Experience in influencing and negotiating with technical personnel in a variety of settings.
• Strong technical writing skills and attention to detail.
• Strong verbal communications skills and demonstrated ability to work in a matrix/team environment. 
• Ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines. 
• Strong computer skills in Microsoft Office applications with the ability to learn new applications quickly and easily.
• Experience with preparation of CMC submissions (INDs, IMPDs, amendments, BLA/MAA, supplements, variations) is preferable 
• Expert knowledge and hands-on experience in at least one area related to CMC Biopharm product development (e.g. analytical or process development, manufacturing, quality control).

·         Apply now

Category Manager
Description :
·         Bachelor's Degree
3+ years industry experience in procurement.
Proficiency with MS Office, especially Excel and Access

Qualifications :
 Advanced Degree
*       Procurement experience in R&D, Supplier innovation and/or marketing categories
• Strong interpersonal and influencing skills
• Problem solving
• Strategic thinking
• Proven ability to work remotely and successfully in global complex organizations
• Managing fast, efficient and transparent information flows

Cash Manager Dealer
Description :
• CertICM or AMCT or equivalent Finance qualification
• Experience of Global Cash Management in a multinational corporate environment. 
• Money market and FX dealing experience
• Good understanding of cash management techniques
• Understanding of financial loans, investments and foreign exchange

Insight Director
Proven application of high quality strategic analysis and ability to develop global strategic / commercial recommendations 
• Thorough conceptual understanding of the vaccines development and commercialization process.
• Credible in a global matrix environment, across a range of functions, seniority, and geographical locations.
• Ability to lead the delivery of multiple task / assignments to demanding deadlines with minimal direction / leadership.
• Ability to manage a team of direct reports

PhD, MSc or Batchelors’ degree in biochemistry, biology, biomedicine, chemistry, pharmaceutical sciences or a related Quantitative Pharmacology or DMPK discipline. 

Deep experience of using mathematical models to integrate available data and applying these to answer practical questions that have a positive impact on programme direction (e.g. PBPK, PKPD).

Good working knowledge of software packages to enable PKPD and PBPK modelling e.g. WinNonLin/Phoenix, GastroPlus, R and Nonmem.

Must possess a high level of drug discovery, ADMET/PK/PD expertise across a variety of delivery routes.

Ability to work across a variety of therapeutic areas covering a range of modalities e.g. NCE’s, Biopharmaceuticals and Cell and gene therapy approaches.

Demonstrated track record of innovation and successful delivery of contributions to projects, for example in lead optimisation phases, including candidate selection, and provision of clear translation strategies and/or into early clinical studies.

Clinical Research Associate
- Perform site evaluations and provide recommendations on site selection, study initiation, data monitoring and collection, patient recruitment and retention evaluation and site close-out activities for assigned sites.
- Partner with Study Management and other relevant stakeholders to ensure optimal study conduct at assigned investigator sites in order to deliver on study objectives.
- Proactively manage the Trial Master File and Country File to required SOP and regulatory standards.  Ensure compliance with inspection readiness requirements.
- Cultivate and maintain strong working relationships and communication with investigators, sites and GSK personnel.
- Identify, escalate and resolve all monitoring and regulatory issues in partnership with investigator, site personnel and study teams.
- Play a role in the development and implementation of efficient and effective approaches to study site management characterised by process standardisation, best practice sharing and continuous improvement, including taking over the “function of an expert”.
- Participate in monitors meetings, trainings relating to monitoring, GCP, SOPs, indications and technologies

Next Post »


Click here for comments
Sajan Bhatti
June 7, 2017 at 12:19 AM ×


Congrats bro Sajan Bhatti you got PERTAMAX...! hehehehe...