Clinical Pharmacology Manager Job Opening at Pfizer
Clinical Pharmacology Manager Job. Pharma Medical Manager. Manager Post vacant @ Pfizer. Pfizer 2019 Jobs, Pfizer Medical jobs, Pharmaceutical Science jobs 2019. Pfizer hiring M Pharma candidates for a Sr. Specialist vacancy. Interested and eligible candidate can apply for this post.
Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
Eligibility: M Pharma
Experience:
- 3 years for a Master’s degree preferred
- Strong teamwork and the ability to work effectively in a matrix environment.
ROLE SUMMARY
Serves as the Clinical Pharmacology representative on assigned bioavailability (BA) and bioequivalence (BE) studies needed for global submissions.
• Provides Clinical Pharmacology support for product defense and maintenance activities for addressing regulatory queries and labeling needs.
ROLE RESPONSIBILITIES
Product Maintenance and Defense Responsibilities
- Responsible for conducting literature searches, writing regulatory queries and labeling requests to support defense and maintenance of PEH products.
- Represents Clinical Pharmacology on teams such as Labeling Teams related to Product Maintenance and Defense.
- Providing technical and non-technical QCs of documents required for regulatory submission, including regulatory responses.
- Provides clinical pharmacology support for various regulatory interactions.
BA/BE Study Responsibilities - Works with the multifunctional study team to design, conduct and report the assigned clinical pharmacology studies ensuring that all processes and activities are fully aligned with Pfizer SOPs, guidelines and regulatory requirements.
- Responsible for interfacing with partner lines (e.g. clinical assay group, statistics, pharmacometrics, clinical) to ensure appropriate support for assigned studies.
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