- Vacation, sick time and holidays
- Volunteer time to participate within your community
- D iscretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
-
Gilead Sciences Boston, United StatesFor Current Gilead Employees and Contractors: · Please log onto your · Internal Career Site · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to dev ...
-
Director, Regulatory Labeling
1 week ago
Insmed Incorporated Bridgewater, United StatesCompany Description: · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicate ...
-
Regulatory Labeling Strategy
3 weeks ago
LanceSoft Cambridge, United StatesRemote EST, 8-5pm · Provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders for successful development of Company Core Data Sheets (CCDSs) and global labeling, i.e., US and EU (CP, MRP, and DCP). E ...
-
Usa - regulatory labeling strategy
3 weeks ago
Randstad Cambridge, United Statesjob summary: · As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of ...
-
usa - regulatory labeling strategy
1 week ago
Randstad Cambridge, United Statesusa - regulatory labeling strategy. · cambridge , massachusetts (remote) · posted 5 days ago · job details · summary · $155 - $167.06 per hour · contract · bachelor degree · category life, physical, and social science occupations · reference47972 · job details · job su ...
-
Associate Director, Global Regulatory Labeling
3 weeks ago
Moderna, Inc. Cambridge, United States Full timeThe Role: · Moderna Therapeutics is seeking an Assoc. Director of Regulatory Labeling to support current and existing programs to be based in its Cambridge headquarters. This is a newly created role intended for a forward-looking, creative regulatory professional able to anticipa ...
-
Associate Director, Regulatory Affairs, Labeling
3 weeks ago
Gilead Sciences, Inc. Boston, MA, United StatesAssociate Director, Regulatory Affairs, Labeling page is loaded · Associate Director, Regulatory Affairs, Labeling · Apply locations United States - Massachusetts - Boston time type Full time posted on Posted 4 Days Ago job requisition id R For Current Gilead Employees and Con ...
-
Associate Director, Regulatory Affairs, Labeling
4 weeks ago
Gilead Sciences, Inc. Boston, United States Paid WorkFor Current Gilead Employees and Contractors: · Please log onto your Internal Career Site $) to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – wor ...
-
Director, Regulatory Labeling
1 week ago
Insmed Incorporated Bridgewater, United States Full time· Company Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedica ...
-
Regulatory Affairs Labeling Specialist
1 week ago
Compunnel, Inc. Andover, United StatesJob Description · Job Description · Description:Laptop will not be issued. Operates complex equipment and analytical tools, processes, state of the art 12'' silicon wafers in a clean room environment, which requires appropriate gowning. Technicians are owned in a gore suit that c ...
-
TalentBurst Andover, United StatesTitle: Regulatory Affairs Specialist - Labeling - Junior · Location: Andover, MA · Shift: M-F, 8AM to 5pm · Duration: 12+ months · Job Description: · Role Overview - · include specific internal and external relationships, product focus, regulatory requirements, physical demands, ...
-
Associate Director, Cmc Regulatory
2 weeks ago
Sarepta Therapeutics Cambridge, United StatesCo-lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the interface with multiple internal and external stakeholders, including partners. · Works as Global Regulato ...
-
Scholar Rock Cambridge, United StatesScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and ...
-
Takeda Pharmaceutical Cambridge, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I subm ...
-
Medical Director, Translational Medicine
2 weeks ago
Novartis Cambridge, United States**About the Role**: · This position can be located in Cambridge, MA or Basel, Switzerland and will not have the ability to be located remotely. · About the role: · 2 Billion plus people are affected by diseases of the nervous system having a dramatic impact on patients and famili ...
-
Medical Director, Neuroscience Translational
2 weeks ago
Novartis Cambridge, United States**About the Role**: · This role is located at our Cambridge, MA site and will not have the ability to be located remotely. · L1-Hybrid · About the role: · More than a billion people are affected by diseases of the nervous system having a dramatic impact on patients and families a ...
-
General Manager
2 weeks ago
The Boston Garden Dispensary Cambridge, United StatesGeneral Manager Job Description · The General Manager (GM) will work closely with leadership to coordinate and facilitate day-to-day operations; overseeing business progress. The GM will lead the success of the storefront by implementing SOPs, supervising staff, tracking and meas ...
-
AstraZeneca Boston, United States**Head of US Advertising and Promotional Compliance** · **This is what you will do**: · The Head of US Advertising and Promotional Compliance, will direct and conduct the regulatory affairs aspects of review and approval of promotional materials and marketing activities for all p ...
-
Sterilization Specialist
2 weeks ago
Pennsylvania Enterprise Boston, United States**Job Overview**: · **Roles & Responsibilities**: · - Manage and execute serialization processes to ensure compliance with regulatory standards. · - Develop and oversee artwork for labelling on bottles and packaging materials. · - Validate and verify serialization and packaging p ...
-
Supervisor of Port Operations
3 weeks ago
Stericycle Boston, United States**About Us**: · Stericycle is a U.S. based business-to-business services company and leading provider of compliance-based solutions that protects people and brands, promotes health and well-being, and safeguards the environment. Since our founding over 30 years ago, we have grown ...
Associate Director, Global Regulatory Labeling - Cambridge, United States - Moderna
Description
The Role:
Moderna Therapeutics is seeking an Assoc. Director of Regulatory Labeling to support current and existing programs to be based in its Cambridge headquarters.
This is a newly created role intended for a forward-looking, creative regulatory professional able to anticipate and address the challenges involved in swiftly delivering labeling for products to new markets.
The Associate Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory labeling, especially the generation of new US prescribing information and changes to existing labeling, and submission of labeling information to Health Agencies.
Here's What You'll Do:
Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed.
Develops labeling content, format and accountability for regulatory submissions (BLAs/MAAs) and related supplements and amendments. Ensure that new labeling text meets regulatory labeling requirements.
Interface with Project Teams to ensure consistency of labeling processes and local compliance with CCDS.
Direct submission of labeling materials and supporting documentation to regulatory agencies in accordance with submission requirements.
Serve as a Labeling expert in Regulatory Affairs sub-teams for activities related to the development of labeling for regulatory submissions.
Effectively communicate the regulatory labeling strategy, risks, mitigations and overall plans to the Regulatory Affairs Management Team, Project Development Team and senior management, as relevant.
Partner with the Global Regulatory Lead to develop Target Label Profiles to support all phases of clinical development (Phase 1-4).
Liaise within the pharmaceutical/biotech industry to maintain knowledge of evolving/emerging industry standards and trends; and influence the industry environment regarding medical writing and labeling.
Here's What You'll Need:
BA/BS degree in a scientific discipline required, Masters or PhD preferred.
10+ years of experience in the Pharmaceutical industry
6+ years of experience in Regulatory labeling
Strong knowledge of current US and EU regulations, including specifically: e.g. vaccine development regulations and registration pathways.
Strong experience with CTD format and content regulatory filings
Exceptional written and oral communication
Experience dealing with a broad range of stakeholders at all levels internal and external to the company
Delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA, etc.)
Here's What You'll Bring to the Table
Experience facilitating meetings and driving consensus and results.
Excellent leadership, communication (verbal and writing) and collaboration skills.
Proven ability in medical/technical writing.
Labeling experience (CCDS, US, EU) in infectious diseases or vaccines or other relevant industry experience related to developing regulatory documentation is desirable.
Integrity:
overriding commitment to integrity and high standards in self and others.
Achievement or Result Orientation:
a concern for working well or for surpassing a standard of excellence.
Strategic orientation:
the ability to link visions and daily work
Communication:
ability and intend to effectively explain, describe or convey information to a variety of audiences.
Specifically, interacts effectively as a member of the Regulatory sub-team, communicates effectively strategies to the Global Labeling Committee and collaborates with business partners, including affiliates and third parties.
Develops others:
involved in a genuine intent to foster the development of others; mentoring
Flexibility/adaptability:
ability to adapt to, and work effectively within a variety of situations and with various individuals or groups.
Relationship building, teamwork and cooperation:
builds or maintains friendly relationships with people and demonstrates a desire to work.
Problem-solving and analytical Thinking: understand a situation by breaking it apart into small pieces or tracing the implications of a situation in a step-by-step way.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
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:
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
Location-specific perks and extras
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team.
We believe in giving our people a platform to change medicine and an opportunity to change the world.By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.
Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visitto learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.
Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society.
We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at. (EEO/AAP Employer)
#J-18808-Ljbffr
