Vice President-Chief Medical

2 weeks ago

Petersburg VA, United States Civica Rx Full time

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.
Today, more than 55 health systems have joined Civica. S. hospital beds. Department of Veteran's Affairs, the U.Department of Defense and the U.Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.
Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients." Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.
To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
(
The Vice President, Regulatory Affairs will join the Civica, Inc. ("The Vice President, Regulatory Affairs:

Leads Regulatory Affairs for sterile injectable, non-sterile, and biologic/biosimilar product development (including biologic/device combination products), review, submission, and FDA approval of Civica's medication portfolio.
Is accountable for the delivery of all regulatory milestones for generic and biosimilar products including assessment of the probability of regulatory success together with risk mitigation measures.
Provides regulatory leadership as needed in product in-license / due diligence review, product divestment and product withdrawal.
Leads the regulatory team in the development and compilation/publishing of documentation for U.FDA investigational new drug (IND), European Medicines Agency clinical trial application (CTA)/investigational medicinal product dossier (IMPD), Abbreviated/New Drug Applications (A/NDA), and biologics license application (BLA) submissions, FDA meeting requests, and correspondence and responses to questions from regulatory authorities, including FDA.
This role offers a flexible remote work style with travel to Civica's Petersburg, Virginia manufacturing facility and Lehi, Utah office as needed.
Lead the Regulatory CMC function to support the CMC portfolio goals with proven track record of successfully building and leading teams.
Lead global CMC regulatory strategies for projects in development and marketed products, including risk mitigation strategies to ensure approvals and maintenance of product licenses.
Leads and represents Civica in regulatory meetings.
Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
Exercise expertise in the interpretation and implementation of FDA guidelines with a goal of an approved/ harmonized regulatory control strategy.
Ensure regulatory conformance & consistency for assigned products in compliance with regulatory requirements and internal procedures.
Oversee regulatory affairs operations including the VEEVA regulatory information management (RIM) platform, and the artwork management system for both Civica owned and private label distribution products.
Partner across the CMC functions in the company, and other functional groups at Civica to support opportunities for regulatory innovation / promote the use of novel approaches within project teams to resolve issues and problems.
A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD.
Application of sound and accurate judgment to make timely decisions.
Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., Demonstrated success in leading complex groups to support operational goals and contribute to the development of global regulatory initiatives.
Strategic thinking capability with business acumen to allow an understanding of how the parts impact the enterprise
Direct support of the submission and approval of regulatory applications, amendments and changes including resolution of information requests
Large scale quality management experience including the design and implementation of effective and compliant quality processes, procedures and tools
Exceptional problem-solving skills to foster the development and implementation of risk-based compliant solutions to business and regulatory challenges
Providing quality and regulatory input across the development and product lifecycle
Process and analytical development and commercial knowledge to facilitate root cause analysis and effective solutions and corrective measures
Building and maintaining complex collaborative relationships capable of influencing the delivery of aligned compliant solutions and decisions
Building consensus and impact outcome without always having line authority
Ability to travel in the U.S. and internationally, as needed, for contract manufacturing oversight and Civica manufacturing site. Travel of up to 20% may be required.

Keywords: VP Compliance, Location:

  • Vice President, Regulatory Affairs

    2 months ago

    Petersburg, United States Civica Rx Full time

    About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They...

  • Vice President, Safety

    1 month ago

    Falls Church, VA, United States HITT Contracting Full time

    Every day, our team members do amazing things in pursuit of our shared purpose to build trust with our clients, partners, subcontractors, and teammates. No matter your background, education, or career path, if you share our vision to create extraordinary experiences, you belong at HITTVice President, SafetyJob Description:The Vice President of Safety will...

  • Vice President-Chief Medical

    1 month ago

    Saint Petersburg, FL, United States Fisher Investments Full time

    Calling all financial professionals looking for a role 100% focused on sales! Take advantage of our well-defined promotion opportunities where qualified leads are provided and there is no cold calling. Join our privately-held, multi-billion dollar, global investment firm to put our clients first and better the investment universe. The Opportunity: You will...

  • Vice President, Contracts

    2 weeks ago

    Herndon, VA, United States Constellis Full time

    POSITION SUMMARYThe Vice President, Contacts is responsible for dynamic market screening, leadership, demand creation, opportunity identification, development, and selection of opportunities that support the business development campaign strategy. The position will also act as a facilitator of cooperation between business development, operations, and...

  • Canadian Client Development Vice President

    2 weeks ago

    Saint Petersburg, FL, United States Fisher Investments Full time

    Are you a financial professional who enjoys building new and expanding current client relationships? As a Canadian Client Development Vice President, you will provide holistic financial planning and portfolio analysis services. Join our privately held, multi-billion dollar, global investment firm to put our clients first and better the investment universe....

  • Assistant Nurse Manager

    1 month ago

    Petersburg, VA, United States Albany Medical Center Full time

    Petersburg, NY, United States Department/Unit: Post Surgical PRN Work Shift: Night (United States of America) The Assistant Nurse Manager performs coordination, planning, administrative management, financial and operational duties in collaboration with the Administrative Nursing Supervisor, Nurse Manager and Assistant Vice President of Specialty Nursing...

  • Canadian Client Development Vice President

    2 weeks ago

    Saint Petersburg, FL, United States Fisher Investments Full time

    Are you a financial professional who enjoys building new and expanding current client relationships? As a Canadian Client Development Vice President, you will provide holistic financial planning and portfolio analysis services. Join our privately held, multi-billion dollar, global investment firm to put our clients first and better the investment...

  • Canadian Client Development Vice President

    1 month ago

    Saint Petersburg, FL, United States Fisher Investments Full time

    Are you a financial professional who enjoys building new and expanding current client relationships? As a Canadian Client Development Vice President, you will provide holistic financial planning and portfolio analysis services. Join our privately held, multi-billion dollar, global investment firm to put our clients first and better the investment...

  • Vice President, International Business Strategy and Planning

    1 month ago

    St Petersburg, United States Raymond James Financial Incorporated Full time

    Job SummaryRaymond James Financial Incorporated is seeking a highly skilled and experienced Vice President, International Business Strategy and Planning to lead the continued strategic development and enhancement of key aspects of our Cross Border/International program. This role will utilize extensive knowledge and critical analytical skills to support the...

  • Albany Medical Center | Assistant Nurse Manager | petersburg, ny

    3 days ago

    petersburg, United States Albany Medical Center Full time

    Petersburg, NY, United States Department/Unit: Short Stay SurgicalWork Shift: Night (United States of America)The Assistant Nurse Manager performs coordination, planning, administrative management, financial and operational duties in collaboration with the Administrative Nursing Supervisor, Nurse Manager and Assistant Vice President ofSpecialty Nursing...

  • Assistant Nurse Manager: E5: Pulmonary/Renal

    3 weeks ago

    Petersburg, United States Albany Medical Center Full time

    Petersburg, NY, United StatesDepartment/Unit:Medical/Surgica Pulmonary Renal Hospitalist - E5Work Shift:Night (United States of America)The Assistant Nurse Manager performs coordination, planning, administrative management, financial and operational duties in collaboration with the Administrative Nursing Supervisor, Nurse Manager and Assistant Vice President...

  • Assistant Nurse Manager: E5: Pulmonary/Renal

    4 weeks ago

    Petersburg, United States Albany Medical Center Full time

    Petersburg, NY, United StatesDepartment/Unit:Medical/Surgica Pulmonary Renal Hospitalist - E5Work Shift:Night (United States of America)The Assistant Nurse Manager performs coordination, planning, administrative management, financial and operational duties in collaboration with the Administrative Nursing Supervisor, Nurse Manager and Assistant Vice President...

  • Assistant Nurse Manager: E5: Pulmonary/Renal

    1 month ago

    Petersburg, United States Albany Medical Center Full time

    Petersburg, NY, United StatesDepartment/Unit:Medical/Surgica Pulmonary Renal Hospitalist - E5Work Shift:Night (United States of America)The Assistant Nurse Manager performs coordination, planning, administrative management, financial and operational duties in collaboration with the Administrative Nursing Supervisor, Nurse Manager and Assistant Vice President...

  • Assistant Nurse Manager: E5: Pulmonary/Renal

    1 month ago

    Petersburg, United States Albany Medical Center Full time

    Petersburg, NY, United StatesDepartment/Unit:Medical/Surgica Pulmonary Renal Hospitalist - E5Work Shift:Night (United States of America)The Assistant Nurse Manager performs coordination, planning, administrative management, financial and operational duties in collaboration with the Administrative Nursing Supervisor, Nurse Manager and Assistant Vice President...

  • Assistant Nurse Manager

    4 weeks ago

    Petersburg, United States Albany Medical Center Full time

    Petersburg, NY, United StatesDepartment/Unit:Neurosciences & Epilepsy Monitoring Unit (EMU) - D5NWork Shift:Day (United States of America)The Assistant Nurse Manager performs coordination, planning, administrative management, financial and operational duties in collaboration with the Administrative Nursing Supervisor, Nurse Manager and Assistant Vice...

  • Assistant Nurse Manager

    1 month ago

    Petersburg, United States Albany Medical Center Full time

    Petersburg, NY, United StatesDepartment/Unit:Neurosciences & Epilepsy Monitoring Unit (EMU) - D5NWork Shift:Day (United States of America)The Assistant Nurse Manager performs coordination, planning, administrative management, financial and operational duties in collaboration with the Administrative Nursing Supervisor, Nurse Manager and Assistant Vice...

  • Assistant Nurse Manager

    1 month ago

    Petersburg, United States Albany Medical Center Full time

    Petersburg, NY, United StatesDepartment/Unit:Neurosciences & Epilepsy Monitoring Unit (EMU) - D5NWork Shift:Day (United States of America)The Assistant Nurse Manager performs coordination, planning, administrative management, financial and operational duties in collaboration with the Administrative Nursing Supervisor, Nurse Manager and Assistant Vice...

  • Assistant Nurse Manager: Pulmonary/Renal Department Lead

    4 weeks ago

    Petersburg, United States Albany Medical Center Full time

    Pulmonary and Renal Hospitalist - E5Department/Unit:Medical/Surgical Pulmonary RenalWork Shift:Night (United States of America)The Assistant Nurse Manager performs coordination, planning, administrative management, financial and operational duties in collaboration with the Administrative Nursing Supervisor, Nurse Manager and Assistant Vice President of...

  • Assistant Nurse Manager

    1 week ago

    petersburg, United States Albany Medical Center Full time

    Petersburg, NY, United StatesDepartment/Unit:Post Surgical PRNWork Shift:Night (United States of America)The Assistant Nurse Manager performs coordination, planning, administrative management, financial and operational duties in collaboration with the Administrative Nursing Supervisor, Nurse Manager and Assistant Vice President ofSpecialty Nursing Division....

  • Chief Medical Officer

    1 month ago

    Prentice Dr, Dulles, VA , USA, United States All HealthCare Staffing, LLC Full time

    Chief Medical Officer Opportunity in the Shenandoah ValleyWe are seeking a highly skilled and experienced Chief Medical Officer to join our team at All HealthCare Staffing, LLC. This is a unique opportunity for a Family Medicine physician with a strong background in both clinical and administrative work.Key Responsibilities:Supervise and manage a team of...