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Senior Manager GRA

Bridgewater, NJ;Cambridge, MA

Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.

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Rewards

  • HEALTH AND WELLNESS PROGRAMS

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • EMPLOYER MATCHING

    Employer matching because Sanofi invests in their employees!

  • PROFESSIONAL DEVELOPMENT

    Sanofi is eager to further your development and expertise in an ever challenging environment.

  • FAMILY SUPPORT

    Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.

  • PAID TIME OFF

    Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!

  • WORK/LIFE BALANCE

    Importance of life outside of the office is valued at Sanofi.

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Responsibilities

With minimal direction from the Sr. Director or AVP, will conduct the independent review of advertising, promotional, medical, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches.As the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects.Mentor less experienced A&P reviewers to help develop talent within the team.Serve as the primary liaison with FDA, for assigned products, on matters related to advertising and promotional compliance matters.

Job Responsibilities

  • Identifies product specific or therapeutic area A&P issues and works with other teams to propose and implement solutions
  • Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters
  • Oversees and bears responsibility for the successful implementation of regulatory strategic objectives and projects with minimal supervision
  • Active participant and Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials, respectively.
  • Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development as well as ultimate promotion, advertising, and reimbursement. Provides input to the Global organization on domestic regulatory strategies for in-line products through life cycle management programs. 
  • Contribute A&P expertise to the development of optimal labeling on new and supplemental new drug applications
  • Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders
  • Performs other duties as assigned

With minimal direction from the Sr. Director or AVP, will conduct the independent review of advertising, promotional, medical, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches.As the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects.Mentor less experienced A&P reviewers to help develop talent within the team.Serve as the primary liaison with FDA, for assigned products, on matters related to advertising and promotional compliance matters.

Job Responsibilities

  • Identifies product specific or therapeutic area A&P issues and works with other teams to propose and implement solutions
  • Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters
  • Oversees and bears responsibility for the successful implementation of regulatory strategic objectives and projects with minimal supervision
  • Active participant and Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials, respectively.
  • Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development as well as ultimate promotion, advertising, and reimbursement. Provides input to the Global organization on domestic regulatory strategies for in-line products through life cycle management programs. 
  • Contribute A&P expertise to the development of optimal labeling on new and supplemental new drug applications
  • Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders
  • Performs other duties as assigned

Education

  • Bachelor’s degree from an accredited four-year college or university
  • Area of specialization:    Life Sciences

Job Related Experience

5-7 Years:

  • Experience within pharmaceutical or medical device Regulatory Affairs
  • Successful track record with ideally 5-7 years relevant regulatory experience
  • Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.

The company reserves the right to consider candidates not possessing these minimum requirements but who possess an equivalent combination of comparable education and experience.   Internal Career Development candidates are one example where minimum educational and job experience requirements may be not be applicable. 

KNOWLEDGE, SKILLS AND EQUIVALENT EXPERIENCE

•           Knowledge and understanding of complex medical and scientific subject matter

•           Ability to work well within cross-functional teams

•           Demonstrates solid oral communication and writing skills

•           Understanding of the U.S. pharmaceutical market place, and familiarity with medical terminology

•           Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution

•           Develops collaborative relationships to facilitate the accomplishment of work goals

•           Develops and proposes innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities

•           Shows ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans

•           Can build networks to obtain cooperation

•           Unquestionable ethics, professional integrity and personal values consistent with the sanofi-aventis values

•           Is able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed

•           Is able to establish priorities and timelines to effectively manage workload. Is able to multi-task well

•           Deals with people in an honest and forthright manner representing information and data accurately

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.

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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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