Manager, Aggregate Reports Analyst
4 weeks ago
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
What You Will Achieve
Your strong documentation skills will be an asset for the team. You will help us draft manuscripts on clinical studies and scientific reports for submission to regulatory agencies or in-company use. You will also help with summaries, monographs, comprehensive reviews, scientific exhibits and projects requiring skill in medical communication.
Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.
It is your problem solving ability that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the division.Drive document strategies and messages in a collaborative way with relevant project team subject matter experts.Ensure documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system.Verify accuracy of document content using source documents including clinical regulatory documents and data tables, figures, and listings.Ensure that medical writing deliverables conform to International Conference on Harmonization and other relevant regulatory guidelines.Lead a team of internal or external authors if multiple or complex documents are required for a particular project.Understand relationships and dependencies between documents and analyses produced for regulators.Independently perform Quality Control (QC) review and manage QC projects in accordance with agreed upon timelines.Contribute to the training of colleagues on quality standards and processes.Develop and sustain constructive relationships within other Pfizer lines including country organizations.Record findings and identify appropriate corrections to address findings.
Qualifications
Must-Have
Bachelor's Degree5+ years' experienceDemonstrated experience in document QC and/or medical writing in the pharmaceutical or biotech industryExperience in interacting with cross functional study team membersSolid understanding of medical terminology and clinical trialsExcellent interpersonal and communication skillsAbility to plan, organize, prioritize, and execute multiple tasks within assigned objectivesProficiency with computer applications (MS Office)
Nice-to-Have
Master's degreeExperience with software commonly used to present and analyze data
Other Job Details:
Last Date to Apply for Job: 26 JUNE 2024.Eligible for referral bonus.
Work Location Assignment: Flexible
Flexible colleagues are assigned a Pfizer site within a commutable distance where they work about 2-3 days weekly to connect and innovate with their team face-to-face. However, they also benefit from being able to work offsite regularly when it makes business sense to do so.
The annual base salary for this position ranges from $93,500.00 to $155, In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | ). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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