Senior Manager of Medical Writing Delivery and Excellence
4 weeks ago
The Senior Manager of Medical Writing Delivery and Excellence is a critical role that requires a high level of expertise in medical writing and regulatory affairs. As a key member of the clinical development team, you will be responsible for delivering high-quality clinical and regulatory writing, from planning and coordination to final draft delivery.
Key Responsibilities
* Develop and manage comprehensive document plans for clinical and regulatory submissions
* Oversee the timely and efficient progress of medical writing deliverables, ensuring all deadlines are met
* Collaborate with cross-functional teams to ensure alignment and integration of clinical and regulatory documents
* Ensure all written documents comply with regulatory, industry, and corporate guidelines and standards
* Interpret and present clinical data and other complex information
Requirements
* Advanced degree (preferred) with a minimum of 4 years of relevant experience OR bachelors degree with a minimum of 9 years of relevant experience
* Proven experience in clinical development, regulatory affairs, or medical affairs
* Proven experience in writing and editing clinical and regulatory documents for submission to global regulatory authorities
What We Offer
* Highly competitive and inclusive medical, dental, and vision coverage options
* Flexible Spending Accounts for medical expenses and dependent care expenses
* Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
* Family care benefits, including subsidized back-up care options and on-demand tutoring
* Free premium access to fitness, nutrition, and mindfulness classes
* Exclusive preferred pricing on Peloton fitness equipment
* Adoption and family-planning benefits
* Dedicated care coordination support for our LGBTQ+ community
* Generous paid time off, including vacation, sick time, and holidays
* Volunteer time to participate within your community
* Discretionary year-end shutdown
* Paid sabbatical after 5 years; every 3 years thereafter
* Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
* 401k match and Financial Planning tools
* Moderna-paid Life, LTD, and STD insurance coverages, as well as voluntary benefit options
* Complimentary concierge service, including home services research, travel booking, and entertainment requests
* Free parking or subsidized commuter passes
About Moderna
Moderna is a leading biotechnology company that is pioneering the development of messenger RNA (mRNA) therapeutics and vaccines. We are committed to revolutionizing the field of medicine and improving the lives of patients worldwide. Our team is passionate about innovation, collaboration, and making a meaningful impact. If you are a motivated and talented individual who shares our vision, we encourage you to apply for this exciting opportunity.
-
Cambridge, Massachusetts, United States KalVista Pharmaceuticals, Inc. Full timeAbout the RoleAs a Senior Manager, Medical Information and Communications, you will be responsible for developing, reviewing, and updating local medical information content. This role will oversee the day-to-day implementation of the global Medical Information strategy, ensuring the delivery of evidence-based information to both internal and external...
-
Senior Manager, HCP Marketing Specialist
4 weeks ago
Cambridge, Massachusetts, United States Biogen Full timeJob OverviewThe Senior Manager, HCP Marketing position at Biogen offers an extraordinary opportunity to join a growing and evolving rare disease franchise in a therapeutic area with high unmet needs. This role is responsible for building and leading HCP engagement activities, including congress and peer-to-peer strategy. The ideal candidate would have...
-
Senior Marketing Manager, HCP
1 month ago
Cambridge, Massachusetts, United States Biogen Full timeAbout This RoleAs a Senior Manager, HCP Marketing, you will be responsible for building and leading HCP engagement activities and initiatives, including key omnichannel programs, for a recently launched product in the Postpartum Depression market. You will focus on enabling branded HCP engagement opportunities and disease state education through well-planned...
-
Senior Data Analyst
4 weeks ago
Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full timeJob Title: Senior Data AnalystJob Summary:We are seeking a highly skilled Senior Data Analyst to join our team at the Massachusetts Institute of Technology. The successful candidate will be responsible for owning data analysis and reporting, providing actionable insights and recommendations to several teams, and building strong analytics systems using...
-
Senior GxP Operations Manager
4 weeks ago
Cambridge, Massachusetts, United States Ipsen Pharma Full timeJob SummaryWe are seeking a highly experienced Senior GxP Operations Manager to join our Quality Assurance team at Ipsen Biopharmaceuticals Inc. This role will be responsible for managing local Training programs, documentation management, and quality events, ensuring compliance with regulatory requirements and company policies.ResponsibilitiesDevelop and...
-
Senior Design Engineer
4 weeks ago
Cambridge, Massachusetts, United States Oxford Global Resources Full timeJob Summary:Oxford Global Resources is seeking a highly skilled Senior Design Engineer to support senior staff in the initiation, design, and delivery of projects. The ideal candidate will have strong engineering skills and practices to gather user requirements and translate them into technical documentation for execution.Key Responsibilities:Employ basic...
-
Cambridge, Massachusetts, United States Pyramid Consulting, Inc Full timePyramid Consulting, Inc. is seeking a highly skilled Senior Scientific Medical Communications/Project Manager to join our team. This is a 03+ Months Contract opportunity with long-term potential.Key Responsibilities:Reporting to the Global Scientific Director, this key role will ensure successful development and execution of medical communications &...
-
Senior Design Engineer
4 weeks ago
Cambridge, Massachusetts, United States Oxford Global Resources Full timeJob SummaryWe are seeking a highly skilled Senior Design Engineer to join our team at Oxford Global Resources. As a key member of our engineering team, you will be responsible for supporting senior staff in the initiation, design, and delivery of projects, particularly method development and experimental design.Key ResponsibilitiesEmploy basic engineering...
-
Senior Design Engineer
4 weeks ago
Cambridge, Massachusetts, United States Oxford Global Resources Full timeJob Summary:As a Design Engineer at Oxford Global Resources, you will support senior staff in the initiation, design, and delivery of projects, focusing on method development and experimental design. This role involves employing basic engineering skills and practices to gather user requirements and translate them into technical documentation for...
-
Senior Capital Project Manager
1 month ago
Cambridge, Massachusetts, United States City of Cambridge Massachusetts Full timeAbout the RoleThe City of Cambridge is seeking a highly skilled and experienced Senior Capital Project Manager to join our team in the Capital Building Projects Department. As a key member of our team, you will be responsible for overseeing the design and construction of large-scale building projects, including new construction and renovation of existing...
-
Senior Finance and Operations Manager
4 weeks ago
Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full timeJob Title: Senior Finance and Operations ManagerJob Summary:We are seeking a highly skilled Senior Finance and Operations Manager to join our team at the Abdul Latif Jameel Poverty Action Lab (J-PAL). The successful candidate will be responsible for supporting J-PAL's mission to efficiently translate research into actionable poverty alleviation policies...
-
Senior Project Engineer
4 weeks ago
Cambridge, Massachusetts, United States DPS Group LLC Full timeJob Title: Senior Project Engineer - Construction and Equipment ManagementWe are seeking a highly skilled Senior Project Engineer to join our team at DPS Group LLC. As a Senior Project Engineer, you will be responsible for managing construction and equipment projects from start to finish, ensuring they are completed on time, within budget, and to the highest...
-
Senior Finance and Operations Manager
4 weeks ago
Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full timeJob Title: Senior Finance and Operations ManagerJob Summary:We are seeking a highly skilled Senior Finance and Operations Manager to join our team at the Abdul Latif Jameel Poverty Action Lab (J-PAL). The successful candidate will support J-PAL's mission to efficiently translate research into actionable poverty alleviation policies around the world.Key...
-
Senior Contracts Manager
4 weeks ago
Cambridge, Massachusetts, United States Draper Labs Full timeJob Summary:The Senior Contracts Manager at Draper Labs will oversee and support a contracts administration team, ensuring internal and external customer satisfaction and driving business results through a team approach. This role involves life cycle oversight of contract administration, utilizing metrics to monitor performance and risk across a diverse...
-
Senior Contract Manager
4 weeks ago
Cambridge, Massachusetts, United States Draper Labs Full timeJob Summary:The Senior Contract Manager will oversee and support a contracts administration team, ensuring internal and external customer satisfaction and business results. This role involves life cycle oversight of contract administration, utilizing metrics to monitor performance and risk across a diverse portfolio of US Government Contracts.Key...
-
Senior Administrative Assistant
1 month ago
Cambridge, Massachusetts, United States City of Cambridge Massachusetts Full timeAbout the Department:The Department of Human Service Programs (DHSP) is a vital part of the City of Cambridge's commitment to enhancing the quality of life for its residents. With a focus on creating and coordinating services that meet the needs of the community, DHSP's extensive programs and services touch every sector of the city, from newborns to senior...
-
Pharmacy Delivery Specialist
4 weeks ago
Cambridge, Massachusetts, United States BrightSpring Health Services Full timeJob SummaryWe are seeking a skilled Pharmacy Delivery Specialist to join our team. As a key member of our logistics team, you will be responsible for delivering pharmacy goods to our clients in a timely and efficient manner.Key ResponsibilitiesLoad and unload materials, goods, and equipment between various destinations as assigned.Manage time and routes for...
-
Senior Manager, HCP Marketing Lead
4 weeks ago
Cambridge, Massachusetts, United States Biogen Full timeJob OverviewWe are seeking a highly skilled Senior Manager, HCP Marketing to lead our HCP engagement activities and initiatives. This role will focus on building and executing omnichannel programs to drive a successful product launch and brand growth.Key ResponsibilitiesDevelop and execute strategic HCP marketing initiatives to drive product adoption and...
-
Benefits Manager
4 weeks ago
Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full timeJob Summary:As a key member of the Human Resources team at the Massachusetts Institute of Technology, the Manager, Benefits Services will oversee the delivery of high-quality benefits services to approximately 20,000 members of the MIT community. This includes managing a team of senior benefits specialists, a client service team, and a Tuition Assistance...
-
Global Senior Specialist, Publishing
4 weeks ago
Cambridge, Massachusetts, United States Moderna Full timeJob SummaryThe Regulatory Operations Senior Publishing Specialist is responsible for planning, creating, and submitting regulatory submissions. In collaboration with the Regulatory Lead, you will plan and prepare high-quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner....