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4.0 - 8.0 years
0 Lacs
hyderabad, telangana
On-site
You will be leading a team of Clinical Supply Project Leaders within a Disease Area, managing multiple complex projects and ensuring network activities while driving cross-functional teams. Your role involves setting up talents, strategies, and processes to best serve business needs. You will have overall end-to-end responsibility for the assigned GCS Development Unit/Disease Area portfolio, ensuring budget accuracy and representing GCS in various meetings and task forces. Fostering a culture of empowerment, trust, learning, diversity & inclusion, and high performance in the team will be crucial. Additionally, you will hold disciplinary and legal responsibility for the team members. As the Operational Manager, you will lead a team of GCS Clinical Supply Project Leaders, ensuring high standards in objective setting, performance monitoring, and development planning. Your responsibilities include talent acquisition, training, and development aligned with business needs, FTE planning, and performance management. You will oversee Disease Area/Development Unit portfolio management, establish strong business partnerships, ensure supply strategy alignment with clinical requirements, and provide regular project overviews within the team and to other functions. Your experience should include over 8 years of practical experience in the chemical/pharmaceutical industry or more than 4 years in the field of expertise. Recognized expertise in the related field, thorough knowledge of Drug Development and Clinical Supply processes, project management skills, and familiarity with relevant regulations are essential. Strong communication, negotiation, interpersonal skills, as well as proven leadership skills, are required. Ability to work in interdisciplinary and cross-cultural teams is a must. Fluency in English is necessary for this role. Novartis is committed to creating an inclusive work environment and diverse teams. If you are ready to lead a team in managing complex projects and drive cross-functional collaboration to serve business needs effectively, this role is for you.,
Posted 2 days ago
7.0 - 11.0 years
0 Lacs
hyderabad, telangana
On-site
As a Sourcing Manager R&D, Drug Development at Novartis Healthcare Private Limited in Hyderabad, you will be responsible for implementing global category strategy at the local level or sourcing business plan for the area of responsibility. Your role will involve directly deploying global category strategy at the site level. You will oversee the implementation of sourcing plans for the sub-category and deliver sub-category savings targets following engagement in the target setting process. Additionally, you will provide input into the overall category segmentation, identify key supplier relationships, and may directly control purchases with respect to supplier choice, timing, and commercial conditions on a local basis. Managing strategic sub-category supplier relationships, implementing consistent key performance indicators for the sub-category, and reporting on suppliers" performance will be part of your responsibilities. You will collect supplier information and feedback from various divisions, countries, sites, category teams, and business partners. Moreover, you will build, apply, complete, and review major contracts for the sub-category ensuring that negotiated contracts are clearly communicated and consistently applied. To excel in this role, you should have a consistent track record in navigating a global, virtual business environment within large organizations. Deep subject matter expertise of the Comparator's business and global landscape is required. Strong abilities to engage with business, manage partners, and drive vendors globally are essential. Additionally, proficiency in Clinical Supply (Packaging, Labelling, Distribution) would be advantageous. Desirable requirements for this position include a university/advanced degree in Business, Lifesciences, or Pharmaceutical sciences, along with 7+ years of experience in Global Strategic Procurement or related roles within the Pharmaceutical industry. Strong written and spoken English skills are necessary for effective communication. Novartis is dedicated to reimagining medicine to improve and extend people's lives. By joining Novartis, you will be part of a mission-driven organization that values its associates and is committed to creating a brighter future together. If you are looking to contribute to breakthroughs that change patients" lives and collaborate with a community of smart, passionate individuals, Novartis offers a rewarding environment for personal and professional growth. Novartis is an equal opportunity employer and is committed to fostering an inclusive work environment that embraces diversity. If you require any accommodations due to a medical condition or disability during the recruitment process or while performing the essential functions of the position, please contact [email protected] to request reasonable accommodation. Novartis values building diverse teams that represent the patients and communities it serves, and is dedicated to creating an outstanding work environment for all employees.,
Posted 3 weeks ago
5.0 - 8.0 years
4 - 8 Lacs
Hyderabad, Madhapur
Work from Office
Key Tasks & Responsibilities: The IRT Manager assumes responsibility for operational execution of the IRT system used in clinical studies in development phases I to IV within clinical operations development operations The IRT is a critical system in ensuring safety of all patients taking investigational medicinal product (IMP,) and if not set-up correctly, could jeopardize the usability of data obtained within the clinical studies. As an expert in IRT, the Manager leads the set-up and testing of the system, ensuring it meets the requirements of the clinical study protocol and that all associated processes are fully compliant with GxP regulations. Revises / develops the clinical study protocol with particular focus on the attributes of study drugs including comparators, medical devices, randomization and blinding. Ensures appropriate supply of study medication for all patients in a clinical trial by implementing optimal IRT supply strategies. The Manager continues to assume accountability of the IRT during the systems life cycle, implementing all required amendments. Leads the IRT cross-functional sub-team and is accountable for the set-up and maintenance of the IRT System with special attention to the proper and correct supply of study sites with study medication, including the correct drug dispensation according to the study protocol. Responsible for providing guidance and training to study teams. Qualifications & Competencies: Bachelors Degree or equivalent. Pharmacist degree preferred 5 to 8 years of relevant healthcare clinical development experience Profound knowledge in drug development Profound knowledge in setting up Interactive Response (IRT) Systems Profound knowledge in GCP and knowledge of GMP Excellent project management skills Excellent communication skills (including fluent English).
Posted 1 month ago
9 - 14 years
11 - 21 Lacs
Bengaluru
Work from Office
CDMA-Clinical Trials Supply Manager- Job Description 1. Lead & keep oversight independently all aspects of the clinical trial supplies for assigned clinical trials. 2. Evaluation and Selection of vendors/service providers for clinical trial supply management. 3. Oversee set up of IxRS tools, monitor the supply utilization, optimization, resupply, accountability, re-conciliation throughout the trial and destruction processes completed after trial completion. 4. Forecast clinical (Investigational and comparator, other Products) and ancillary (non-drug product) supply requirements. 5. Calculate clinical supply requirements and provide the requirements to internal team for supply readiness proactively. 6. Oversee the procurement of comparator and any additional drug products as required for clinical trials with necessary documents. 7. Co-ordinate and review the packaging & labelling activities including design of Product labels and expiry extension if any and oversee the label design and approval processes. 8. Liaise with internal functions of Biocon and external partners and providers (CRO, others) in driving the clinical supplies shipments and monitor the temperature excursions accordingly. 9. Create or update SOPs required for clinical trial supply management.
Posted 3 months ago
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