Current jobs related to Associate Director/Director Clinical Regulatory Writing, Cardiovascular, Renal Metabolism - Boston - AstraZeneca
-
Boston, United States AstraZeneca Full timeAre you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us at Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs to get involved in the global regulatory strategies and support the research, development and commercialization of our...
-
Clinical and Regulatory Medical Writing Director
21 hours ago
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob DescriptionVertex Pharmaceuticals is seeking a highly skilled Medical Writing Director to join our team. As a key member of our Medical Writing function, you will be responsible for the management, oversight, operation, and direction of Clinical Regulatory Writing in support of our Pain program.Key Responsibilities:Independently author routine and...
-
Director/Senior Director, Medical Writing
4 weeks ago
boston, United States Meet Full timeDirector/Senior Director, Medical Writing*Remote Opportunity* - hybrid in Boston, MA highly preferred. Remote in EST is also fine.Meet has partnered with an exciting biotech based in Boston, MA that is focused in oncology and immunology. They have a strong development pipeline with programs ranging from P1-P3. They are seeking a Director or Senior Director...
-
Director/Senior Director, Medical Writing
4 weeks ago
boston, United States Meet Full timeDirector/Senior Director, Medical Writing*Remote Opportunity* - hybrid in Boston, MA highly preferred. Remote in EST is also fine.Meet has partnered with an exciting biotech based in Boston, MA that is focused in oncology and immunology. They have a strong development pipeline with programs ranging from P1-P3. They are seeking a Director or Senior Director...
-
Director/Senior Director, Medical Writing
1 month ago
Boston, United States Meet Full timeDirector/Senior Director, Medical Writing*Remote Opportunity* - hybrid in Boston, MA highly preferred. Remote in EST is also fine.Meet has partnered with an exciting biotech based in Boston, MA that is focused in oncology and immunology. They have a strong development pipeline with programs ranging from P1-P3. They are seeking a Director or Senior Director...
-
Associate Director, Clinical Data Management
4 months ago
Boston, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...
-
Associate Director, Clinical Data Management
3 weeks ago
boston, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 3 Days a week in office (2 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...
-
Associate Director, Clinical Data Management
4 months ago
Boston, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...
-
Associate Director, Clinical Data Management
3 weeks ago
boston, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 3 Days a week in office (2 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...
-
Boston, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 3 Days a week in office (2 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...
-
Boston, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 3 Days a week in office (2 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...
-
Director of Medical Writing
2 weeks ago
Boston, United States Boston-Based Biotech Full timeDirector of Medical WritingWe are partnering with a clinical-stage biotechnology company in the Boston area advancing the next generation of oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurological diseases. They are seeking someone who will lead the development of regulatory and clinical documents...
-
Director of Medical Writing
2 weeks ago
Boston, United States Boston-Based Biotech Full timeDirector of Medical WritingWe are partnering with a clinical-stage biotechnology company in the Boston area advancing the next generation of oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurological diseases. They are seeking someone who will lead the development of regulatory and clinical documents...
-
Director of Medical Writing
2 days ago
boston, United States Boston-Based Biotech Full timeDirector of Medical WritingWe are partnering with a clinical-stage biotechnology company in the Boston area advancing the next generation of oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurological diseases. They are seeking someone who will lead the development of regulatory and clinical documents...
-
Director of Medical Writing
1 day ago
Boston, United States Boston-Based Biotech Full timeDirector of Medical WritingWe are partnering with a clinical-stage biotechnology company in the Boston area advancing the next generation of oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurological diseases. They are seeking someone who will lead the development of regulatory and clinical documents...
-
Medical Director
3 weeks ago
Boston, United States Albion Rye Associates Full timeJob Title: Medical Director – Metabolic Disorders BiotechLocation: Boston, MAJob Type: Full-TimeReports to: Chief Medical Officer (CMO) or VP of Clinical DevelopmentIndustry: Biotechnology – Metabolic DisordersPosition OverviewWe are seeking a highly skilled and motivated Medical Director to join our dynamic team in Boston at a leading biotechnology...
-
Medical Director
3 weeks ago
Boston, United States Albion Rye Associates Full timeJob Title: Medical Director – Metabolic Disorders BiotechLocation: Boston, MAJob Type: Full-TimeReports to: Chief Medical Officer (CMO) or VP of Clinical DevelopmentIndustry: Biotechnology – Metabolic DisordersPosition OverviewWe are seeking a highly skilled and motivated Medical Director to join our dynamic team in Boston at a leading biotechnology...
-
Director of Regulatory Affairs
4 weeks ago
boston, United States Blackfield Associates Full timeBlackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...
-
Director of Regulatory Affairs
1 month ago
Boston, United States Blackfield Associates Full timeBlackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...
-
Director of Regulatory Affairs
1 month ago
Boston, United States Blackfield Associates Full timeBlackfield Associates is exclusively partnered with a clinical stage biotech company that is pioneering in the development and approval of rare disease innovative treatments. We are looking to hire a Director, Regulatory Affairs to lead the US regulatory strategy firsthand. Regulatory Director Key Responsibilities:Provide strategic and operational leadership...
Associate Director/Director Clinical Regulatory Writing, Cardiovascular, Renal Metabolism
3 months ago
Are you passionate about science and experience within regulatory affairs and drug development? We are now recruiting a Director, Clinical Regulatory Writing (CReW). In this role you will provide expert leadership to the delivery of the CVRM product pipeline through partnering with senior leaders to define and lead the global communications strategy. You will be a leader for clinical regulatory writing activities within the disease area for cross functional teams and external vendor partners.This opportunity is available at our Boston Seaport, MA (USA) location. We expect employees to be on-site for a minimum of three days per week and are therefore unable to offer remote based working.Director CReW develops communications strategies to guide these programs while advocating and developing best practices for document and accelerated submission delivery, representing strategic communications expertise in business process optimisation and improvement initiatives, and supporting the growth and development of internal talentWhat Youll DoAs a leader in CVRM CReW you will be expected to:Provide expert leadership to deliver submission communication strategies and drive the authoring of large clinical submission packages and other complex clinical documents that are aligned with project development plans, regulatory requirements, and communications best practices.Create robust clinical arguments through strong analytical and communications skills and critically evaluate clinical trial designs.Be a proactive, independent, and innovative leader of large, complex teams.Delegate and empower other internal and external writers, and ensure relevant regulatory, technical, and quality standards are achieved and the appropriate processes and best practice are applied.Effectively influence stakeholders and colleagues at the highest levels of a program to establish best communications practices.Relentless in the pursuit of excellence, driven to improve standards across the business. Recognize opportunities and spearhead improvement initiatives at the TA or company-wide level.Support the growth and development of the CVRM CReW community by actively mentoring less experienced writers and serving as a role model for the function.Manage and prioritize multiple projects in parallel, often working under accelerated timelines to deliver.Essential for the Role:An Advanced Degree (Masters Degree or equivalent) in a scientific field or appropriate subject area.At least 6 years of proven experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or CRO environment.Broad cross-functional understanding of the drug development process from scientific, technical and business perspectives.Experience in leading large, diverse teams.Excellent verbal and written communication skills in English.Conceptual and strategic problem-solving ability with strong networking and influencing skills.Flexibility in adapting to changing circumstances or new information.Desirable Qualifications:Ph.D in a scientific field with 8 years of proven experience.Extensive knowledge of the latest technical and regulatory expectations.Excellent organizational, analytical, decision-making, and interpersonal skills to manage complex projects simultaneously and to handle rapidly changing priorities.Why AstraZeneca?At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means were opening new ways to work, pioneering ground-breaking methods and bringing unexpected teams together. Interested? Come and join our journey.We are eager to know more about you. If you are interested to know more about us, apply nowAs AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move to Kendall Square/Cambridge in 2026. Find out more information here: Kendall Square Press ReleaseDate Posted07-Jun-2024Closing Date31-Jul-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.SummaryLocation: US - Boston - MAType: Full time
