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Sr Manager, Global Regulatory Intelligence & Analysis

Employer
Pfizer
Location
Collegeville, Pennsylvania
Start date
Sep 22, 2022

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work
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Job Details

Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

You will be an integral part of the Global Regulatory Intelligence & Analysis (GRIA) team, located within the Global Regulatory Policy & Intelligence (GRPI) function. GRIA has a business-critical mission to provide Pfizer regulatory strategy teams with a competitive advantage by delivering industry leading regulatory intelligence, analysis, and tools that are optimized to inform innovative patient-centric strategic regulatory decisions.

As a Senior Manager, in GRIA, you will be responsible for the monitoring and delivery of global regulatory competitive intelligence and analysis for assigned focus areas (e.g., therapy areas, asset teams, special projects). You will also be expected to optimize the value derived from Pfizer intelligence tools and from the wider Pfizer global competitive intelligence network. The position will have lead responsibilities for certain projects, while acting in a support capacity for others.

The successful applicant will apply and expand their broad background and skill set, including knowledge of drug development, understanding of the evolving regulatory environment and diverse pharmaceutical business experience including prior experience in several areas within global regulatory affairs to provide intelligence and insight that advances regulatory strategies.

Reports to Senior Director or Director, GRPI

How You Will Achieve It

  • Delivery of Strategic Regulatory Competitive Intel & Analysis

  • Apply regulatory knowledge to conduct the proactive monitoring, capture, and impact analysis of disease area specific emerging competitive regulatory intelligence to Pfizer regulatory strategies for assigned therapy area(s) and projects. This work will be done with input from Director/Sr Director GRIA, where the sophistication of the analyses and ability to work increasingly independently will increase over time.

  • Analyze the strategic significance of recent past and forthcoming regulatory events for trends and their potential impact on the Pfizer portfolio and therapy area regulatory environment. This is a combination of proactive analyses and delivery of timely responses to regulatory queries from stakeholders.

  • Develop strong internal networks with other Intelligence groups and cross-functional partners, and work closely with them to identify, integrate, and disseminate relevant, targeted Regulatory insights/learnings that inform therapy area regulatory strategy and policy/advocacy strategies.

  • Strategic Management & Utilization of Reg Intel Assets

  • Optimize content, usability, and reach, of the Regulatory Intelligence (RI) platforms and RI distribution channels to maximize efficiency and use by GRPI stakeholders.

  • Optimize collection and archiving of external intel

  • Share/Input data into systems/tools to enable effective knowledge management of country level intelligence data (i.e., support Pfizer’s ability to tap into internal sources of regulatory intelligence across the company)

  • Lead optimization and governance of RI tools (internal & external)

  • Support development and deployment of new technologies (e.g., automation, natural language processing, machine learning, artificial intelligence) in partnership with other technical groups, to increase regulatory intelligence capabilities

  • Represent GRIA on cross-functional teams/projects dedicated to governance and continuous intel improvement/efficiencies and ensure GRIA needs are voiced and incorporated into Pfizer Divisional and enterprise solutions.

Qualifications

Must-Have

  • Minimum BS degree or equivalent in a scientific discipline.

  • Minimum 7 years combined industry experience in regulatory intelligence and regulatory strategy.

  • Solid understanding of how competitor activities and the evolving global regulatory environment can be used to shape and impact regulatory strategy.

  • Expert ability to effectively navigate, identify, extract, analyze, and communicate targeted intelligence from a wide range of sources (e.g., subscription databases, health authority websites, other systems, etc.).

  • Expert ability to evaluate utility/value of external resources for collecting regulatory intelligence.

  • Highly adept posting to, organizing, and retrieving material from wide range of databases and web-based tools; proficiency in archival information systems (e.g., SharePoint).

  • Customer focused and adaptable, with the ability to seamlessly balance and manage multiple projects from multiple stakeholders to time and quality.

  • Strong strategic thinking, project management, and problem-solving skills (e.g., issue identification, method/tool selection).

  • Strong attention to detail and ability to deliver in a fast-paced environment with rapidly changing priorities.

  • Strong written and verbal communication skills (ability to clearly synthesize intel from multiple sources, and to communicate the most important aspects in clear, concise, effective manner).

  • Proven ability to collaborate with others.

  • High functioning as both a team player & individual contributor.

  • Demonstrated success in negotiating the environment of a highly matrix-based organization.

  • Digital and computer literacy (e.g., Excel, Word, Power Point, etc.).

Nice-to-Have

  • Advanced life science degree

  • Competitive intelligence and/or clinical development experience

  • Experience in Immunology & Inflammation, Internal Medicine, or Hospital Products drug development preferred. (Rare Disease or Vaccine experience also beneficial)

  • Proficient interacting with technical experts to support the development, launch, and use of artificial intelligence (AI), natural language processing (NLP) and other innovative tools and approaches. Note, having awareness of the potential for how these technological advances could transform Reg Intel is beneficial; however, specific technical expertise of AI, NLP, etc. is not needed.


Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PHYSICAL/MENTAL REQUIREMENTS

Nothing specific beyond qualifications and requirements above

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Most work is expected to be conducted virtually or at a Pfizer site, but some travel for intel collection (e.g., conference and health authority meeting coverage) team meetings and training will be required (~10-15 days/year). These may require overnight stays, with most travel being domestic, but some international travel may be required.

Relocation assistance may be available based on business needs and/or eligibility.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

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 work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Regulatory Affairs

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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