Sanofi Group Periodic Reporting Manager in Cambridge, Massachusetts
The Periodic Reporting Manager will be expected to prepare and review Annual Reports (AR), Annual Report amendments, Periodic Adverse Drug Events Reports (PADER), Global Report Publishing, and other required regulatory documents.
Track and analyze analyses errors to identify root causes and to recommend remediation strategies aimed at reducing error rates
Provide back-up support in the generation of the specified regulatory documents and the candidate will be fully knowledgeable of the process
Provide highest level quality assurance of AR /AR Amendment/PADER documents and assistance in execution of the process for generating these documents.
This role includes quality assessment of both the regulatory documents and the process to ensure the following:
that all studies are appropriately classified for inclusion/exclusion
that all reportable studies sponsored by sanofi are included in the report
that comments in the spreadsheet are accurate
that study synopses for completed clinical studies meet the established standards
validation of all documentation for the ARs and/or amendments, e.g., NDA (New Drug Application), PADER (Periodic Adverse Drug Experience Report), and PMA (Pre-Market Approval) for submission to the FDA.
Interaction with contributors in the planning and publishing of global documentation for inclusion in Regulatory submissions, manage workload and meet deadline requirements.
Bachelor’s Degree in Life Science (referred) or related field, preferred.
Exceptional project management, including managing multiple complex projects from start to completion
Demonstrated involvement in cross-functional teams and capabilities in planning, initiation, executing, and reporting activities.
Demonstrated functional knowledge of Good Clinical Practices, Corporate policies and standard operating procedures as well as knowledge of applicable external regulatory requirements and guidelines
Extensive knowledge of the regulatory requirements for various periodic reports, including knowledge of pharmaceutical clinical trial process and AR documentation requirements.
Ability to work under tight timelines and excellent attention to detail is essential.
Strong skills in Excel, and the ability to work with databases, e-rooms, and clinicaltrials.gov, etc. in an electronic environment. .
Other required skills and attributes
Demonstrated superb organizational, time management and communication skills (verbal and written)
Demonstrated experience working on multiple projects simultaneously
Strong interpersonal skills with the ability to interact with all levels of the organization
Strong problem-solving, follow-through and decision-making skills for assigned programs with minimal supervision
Proven ability to work both independently and in a team setting, and to meet goals by managing timelines
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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