At Pfizer, your ideas will help power a new generation of medicines - the breakthroughs that will make life a little easier to live for people everywhere. Whether you work with technology, finance or face-to-face with doctors and healthcare providers, everything you do impacts everything we do. This is your career at Pfizer - a career unlike any other.
Medical Director/Sr. Medical Director- Established Products BU Job in New York City 10001, New York US
Description:
Provides medical and operational oversight and leadership on key activities for this portfolio
- Responsible for all US-based regulatory and safety activities related to their portfolio in collaboration with the Portfolio Medical Leads
- Provides a critical review of Medical Education Grants and Investigator Initiated Research proposals
- Collaborates with Medical Information and serves as key point of contact with country/regional medical and regulatory colleagues
- Implement adapted revitalization plans including re-conceptualization of existing data, data mining, guidance for new formulation and packaging, clinical plan etc.
- Provide medical support for CTRD and clin.gov.com initiatives
- Provide subject matter expertise and strategic leadership on reformulation efforts, abbreviated and supplemental submissions (aNDAs, sNDa, MMAs, aMMAs) and rapid response teams to assure appropriate support for US business deliverables
- Provide medical leadership in the management of safety issues and safety letters
- Partner with WPM, Pharm Sci, Clinical R&D in the coordination of clinical oversight of FDA-mandated post marketing studies
- Lead US Publications Steering Committee and ensure publication plan is consistent with Pfizer policies
- Provides a critical review and medical input into promotional materials
- Partner with finance on budget planning and management
- Ability to set up effective knowledge transfer processes and to synthesize large amounts of data/product information during the transition of products from PFE Therapeutic Area teams or from external acquisitions.
Is compliant with all required SOPs and training
Qualifications:
MD, PhD, or PharmD, with 3+ years experience in a pharmaceutical environment. This position requires a proactive, pragmatic, flexible person with excellent leadership qualities, strategic thinking, communication & presentation skills, broad expertise in medical and strong experience with regulatory and/or safety risk management issues. The US Medical Director will collaborate with internal and external stakeholders in a professional and enthusiastic manner, and must work well on multiple tasks and effectively prioritize to meet personal and team goals in a matrixed team environment. He/she will contribute to ongoing efforts to enhance team effectiveness through involvement in continuous improvement initiatives.
Technical Skill Requirement
Ability to analyze and interpret bodies of data.
Search appropriate data bases/systems for clinical data and/or information.
Develop verbal and/or written arguments in a logical and cogent manner.
Salary/Benefits: Salary commensurate with experience
Throughout our 153 years, a legacy of caring for
others has been at the heart of everything we do
at Pfizer. This commitment is no less important
when it comes to our employees. Pfizer wants to
ensure that employees have resources to help them
develop and succeed both in their careers and
personal lives. One way we can achieve this is
through our comprehensive benefits program, which
offers employees and their eligible dependents the
variety and flexibility to help address their
needs at different stages in life.
Job Location: New York, NY
Job Number: 83309
Company URL: http://www.pfizer.com
Company Profile:
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site. Pfizer may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer.
Provides medical and operational oversight and leadership on key activities for this portfolio
- Responsible for all US-based regulatory and safety activities related to their portfolio in collaboration with the Portfolio Medical Leads
- Provides a critical review of Medical Education Grants and Investigator Initiated Research proposals
- Collaborates with Medical Information and serves as key point of contact with country/regional medical and regulatory colleagues
- Implement adapted revitalization plans including re-conceptualization of existing data, data mining, guidance for new formulation and packaging, clinical plan etc.
- Provide medical support for CTRD and clin.gov.com initiatives
- Provide subject matter expertise and strategic leadership on reformulation efforts, abbreviated and supplemental submissions (aNDAs, sNDa, MMAs, aMMAs) and rapid response teams to assure appropriate support for US business deliverables
- Provide medical leadership in the management of safety issues and safety letters
- Partner with WPM, Pharm Sci, Clinical R&D in the coordination of clinical oversight of FDA-mandated post marketing studies
- Lead US Publications Steering Committee and ensure publication plan is consistent with Pfizer policies
- Provides a critical review and medical input into promotional materials
- Partner with finance on budget planning and management
- Ability to set up effective knowledge transfer processes and to synthesize large amounts of data/product information during the transition of products from PFE Therapeutic Area teams or from external acquisitions.
Is compliant with all required SOPs and training
Qualifications:
MD, PhD, or PharmD, with 3+ years experience in a pharmaceutical environment. This position requires a proactive, pragmatic, flexible person with excellent leadership qualities, strategic thinking, communication & presentation skills, broad expertise in medical and strong experience with regulatory and/or safety risk management issues. The US Medical Director will collaborate with internal and external stakeholders in a professional and enthusiastic manner, and must work well on multiple tasks and effectively prioritize to meet personal and team goals in a matrixed team environment. He/she will contribute to ongoing efforts to enhance team effectiveness through involvement in continuous improvement initiatives.
Technical Skill Requirement
Ability to analyze and interpret bodies of data.
Search appropriate data bases/systems for clinical data and/or information.
Develop verbal and/or written arguments in a logical and cogent manner.
Salary/Benefits: Salary commensurate with experience
Throughout our 153 years, a legacy of caring for
others has been at the heart of everything we do
at Pfizer. This commitment is no less important
when it comes to our employees. Pfizer wants to
ensure that employees have resources to help them
develop and succeed both in their careers and
personal lives. One way we can achieve this is
through our comprehensive benefits program, which
offers employees and their eligible dependents the
variety and flexibility to help address their
needs at different stages in life.
Job Location: New York, NY
Job Number: 83309
Company URL: http://www.pfizer.com
Company Profile:
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site. Pfizer may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer.
Join the company that is touching more lives in more ways than you ever thought possible. Visit our web site for more information about our different business groups, our products and our plans for the future. Expect more from your career. Explore the opportunities at Pfizer.
Pfizer is an Equal Opportunity Employer.
Additional Information
Salary:
Salary commensurate with experience
Salary commensurate with experience
Position Type: Full Time, Employee
Ref Code: 83309.1290
