Local Infusion is seeking a skilled and experienced pharmacist to consult during the pharmacy application process. The consulting pharmacist will provide expertise in administrative and credentialing work, review policies and procedures, and ensure compliance with regulatory and accreditation standards. The majority of this work can be completed remotely, but onsite presence will be necessary.
Job listings
We are seeking a highly experienced Consultant Pharmacist to advise Boulder Care on pharmacy-related challenges and represent our clinical team in external conversations. This role is designed for a seasoned pharmacist with deep experience in independent pharmacy management and regulatory navigation in the MOUD space who can add strategic expertise and credibility as Boulder expands to a national footprint.
Serve as the medical scientific lead responsible for communicating the value of Nuvalentβs clinical and health economics and outcomes data to payer formulary decision makers. Develop and foster relationships while compliantly engaging in peer-to-peer scientific and health economic discussions with customers to optimize patient access to Nuvalent products. As a member of the Medical Affairs team, cultivate strong matrix team partnerships.
The Clinical Care Pharmacist plays a vital role in promoting safe, effective, and appropriate medication use and is responsible for reviewing prior authorization requests, supporting clinical programs, and providing expert guidance to members, providers, and pharmacies. The role combines clinical decision-making with a strong focus on service excellence in a fast-paced, collaborative environment.
Oversight and understanding of all aspects of the assigned productβs safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data. Facilitate Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data.
Reporting to the Senior Director of Medical Affairs, the Director, Medical Affairs Strategy will support the development and execution of Medical Affairs strategy. This role will contribute to cross-functional planning and implementation of medical initiatives, including advisory boards, evidence generation, investigator-sponsored research (ISR), and promotional/medical material review.
Review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. This includes coding, assessment of seriousness, expectedness, and company causality, as well as writing of company comment, follow-up questions and analysis of similar events.
This role provides leadership, direction, and Quality Assurance (QA) oversight of contract manufacturers (CMOs) and service providers for cell bank, drug substance (DS), drug product (DP), packaging and labeling, and distribution of multiple products. The Sr. Director collaborates closely with CMC, Quality Compliance and Analytical Development colleagues to ensure compliance with all relevant cGMP regulations and guidelines as they pertain to manufacturing and supply operations, and ensures staff execute within the companyβs Quality Management System.
Serves as Global Safety Lead and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product. Leads GPSE Safety Team and Safety Management Team for assigned compounds and products. Manages cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.
Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product. Leads GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products. Manages cross-functional assessment of benefit-risk profile and communication of safety information.