Clinical and Regulatory Medical Writing Director
24 hours ago
Vertex 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 complex clinical and regulatory documents
- Advises development teams on the content and optimal presentation of documents to facilitate achievement of submission objectives
- Provides strategic input into program-level and therapeutic area plans, including defining the direction of the clinical development program or regulatory strategies
- Optimizes interdisciplinary understanding and synergy within group(s) and integrate activities with those of other department and project teams
- Manages resource plans for projects within their oversight ensuring appropriate staff are available to meet program goals
- Provides coaching and mentorship for junior staff members
- Plans strategically, anticipates problems, and recommends process improvements to address current and future needs
- Provides expert review of policies and procedures for the department
- Innovates and leads process improvements with high cross-functional impact
- Ph.D. (or equivalent degree)
- Typically requires 10 years of work experience and 3 years of mentorship/supervisory experience, or the equivalent combination of education and experience
- Opportunity to work with a global biotechnology company
- Collaborative and dynamic work environment
- Competitive salary and benefits package
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Regulatory Affairs Director
1 week ago
Boston, Massachusetts, United States Fairway Consulting Group Full timeJob Title: Director, Regulatory AffairsWe are seeking a highly experienced Director, Regulatory Affairs to join our team at Fairway Consulting Group. As a key member of our team, you will be responsible for providing strategic regulatory leadership and guidance to project teams, ensuring clinical trials are designed to meet regulatory requirements, and...
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Regulatory Affairs Director
2 weeks ago
Boston, Massachusetts, United States Fairway Consulting Group Full timeDirector, Regulatory AffairsFairway Consulting Group is seeking a seasoned Director, Regulatory Affairs to join our team. As a key member of our client's organization, you will play a critical role in shaping the company's regulatory strategy and ensuring compliance with global regulations.Key Responsibilities:Develop and implement global regulatory...
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Regulatory Affairs Director
4 weeks ago
Boston, Massachusetts, United States Fairway Consulting Group Full timeJob Description:Job Title: Regulatory Affairs DirectorCompany: Fairway Consulting GroupJob Type: Full-timeLocation: RemoteJob Category: Healthcare, Life SciencesAbout Us: Fairway Consulting Group is a leading executive search firm specializing in healthcare and life sciences recruitment.Job Summary: We are seeking an experienced Regulatory Affairs Director...
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Regulatory Affairs Director
2 weeks ago
Boston, Massachusetts, United States Fairway Consulting Group Full timeDirector, Regulatory AffairsFairway Consulting Group is seeking a seasoned Director, Regulatory Affairs to join our team. As a key member of our client's organization, you will play a critical role in supporting global regulatory strategy and execution on development programs.Key Responsibilities:Supports global regulatory strategy and execution on...
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Clinical Services Director
3 weeks ago
Boston, Massachusetts, United States A.P.R., Inc. (AlphaProTemps) Full timeJob OverviewWe are seeking a highly skilled Clinical Services Director to join our team at A.P.R., Inc. (AlphaProTemps). This is a unique opportunity to leverage your expertise in clinical pharmacology and pharmaceutical sciences to drive strategic leadership and technical oversight in the review, analysis, and interpretation of study results.Key...
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Medical Director Clinical Science Lead
7 days ago
Boston, Massachusetts, United States Sobi Full timeJob Title: Medical Director Clinical ScienceSobi is seeking a highly skilled Medical Director Clinical Science to lead our clinical development activities and serve as a scientific and medical expert on matters relating to our assigned development program.Key Responsibilities:Provide clinical, scientific, and strategic input to clinical development plans and...
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Regulatory Labeling Director
2 weeks ago
Boston, Massachusetts, United States ProClinical Full timeDirector, Regulatory LabelingProclinical is collaborating with a pioneering pharmaceutical company to find a Director of Regulatory Labeling to lead the delivery of cutting-edge labeling for key products in the US and major global markets.Key Responsibilities:Develop and execute US/major market labeling, including submissions to Health Agencies.Collaborate...
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Regulatory Affairs Director
1 week ago
Boston, Massachusetts, United States ProClinical Full timeSenior Director, Regulatory Affairs **Job Summary:** Proclinical is seeking a seasoned regulatory professional to lead our vaccine development programs. As Senior Director, Regulatory Affairs, you will be responsible for driving regulatory efforts and ensuring compliance across major markets. **Key Responsibilities:** * Develop and execute regulatory...
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Boston, Massachusetts, United States AbbVie Full timeJob SummaryWe are seeking a highly skilled Medical Director to lead our Oncology Clinical Development team. As a key member of our organization, you will be responsible for overseeing the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs.Key ResponsibilitiesManage and...
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Podiatrist - Medical Director Services PC
4 weeks ago
Boston, Massachusetts, United States Medical Director Services PC Full timeJob Summary:Medical Director Services PC is seeking an experienced Podiatrist to provide professional and medical podiatric services to patients with conditions affecting the foot, ankle, and related structures in skilled nursing facilities throughout Massachusetts. Inquire about availability in other states as well.Key Responsibilities:Provide essential...
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Clinical Scientist Director
4 days ago
Boston, Massachusetts, United States TEEMA Full timeJob DescriptionTEEMA is seeking a highly motivated and experienced Clinical Scientist Director to lead clinical development activities for our Pharmaceutical company specializing in GI diseases. The successful candidate will work closely with the Global Clinical Development Lead to design, execute, and interpret clinical trials and the clinical development...
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Regulatory Affairs Director
2 weeks ago
Boston, Massachusetts, United States Vertex Full timeJob OverviewVertex is seeking a highly skilled Associate Director of Chemistry Manufacturing Controls to execute global regulatory CMC strategies for investigational and marketed products. This role will lead the preparation and filing of regulatory CMC submissions, manage interactions with Health Authorities, and provide regulatory guidance to...
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Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob SummaryVertex Pharmaceuticals is seeking an experienced Senior Medical Director to lead clinical development in the area of inflammation. The successful candidate will work closely with cross-functional teams to define disease strategy and clinical trials strategy, design, and execution.Key ResponsibilitiesDevelop and execute clinical development plans...
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Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob SummaryThe Senior Medical Director, T1D will lead the development of translational strategies for T1D and be accountable for delivering key milestones. This role will work closely with cross-functional teams to define overall translational strategy, clinical trials strategy, design, and execution.Key ResponsibilitiesDevelop and implement clinical...
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Regulatory Affairs Director
2 weeks ago
Boston, Massachusetts, United States The Steely Group Full timeJob SummaryThe Steely Group is seeking a highly experienced Regulatory Affairs Director to lead our regulatory strategy and ensure compliance with global regulations. As a key member of our team, you will be responsible for establishing and communicating regulatory strategies, managing regulatory activities, and providing strategic direction to staff.Key...
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Boston, Massachusetts, United States Planet Pharma Full timeAbout the RoleWe are seeking a highly skilled and experienced Director of Global Regulatory Strategy and Development to join our team at Planet Pharma. As a key member of our regulatory affairs team, you will play a critical role in developing and implementing global and US regulatory strategies for our unique and technologically complex products serving...
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Boston, Massachusetts, United States Boston Medical Center Full timeMedical Director for Addiction Services Clinical PsychiatristBoston University Chobanian & Avedisian School of Medicine is seeking a Medical Director for Addiction Services Clinical Psychiatrist to join our faculty. As a clinical psychiatrist with a passion for program development and strategic planning, you will oversee out-patient addiction services and...
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Medical Director
1 week ago
Boston, Massachusetts, United States Medicorp Inc Full timeJob Title: Medical Director - MassachusettsMedicorp Inc is seeking a highly skilled Medical Director to lead our Primary Care Site in Massachusetts.Job Summary:The Medical Director will be responsible for overseeing the daily operations of the site, managing a team of healthcare professionals, and ensuring the delivery of high-quality patient care.Key...
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Director, Regulatory Affairs, Advertizing
4 weeks ago
Boston, Massachusetts, United States Piper Companies Full timePiper Companies is seeking a seasoned professional to lead the Neurology Regulatory Affairs team as Director of Regulatory Affairs (Ad & Promo). Key Responsibilities:• Develop and implement regulatory strategies for advertising and promotional materials• Collaborate with cross-functional teams to create compliant labeling, advertising, and promotional...
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Regulatory Affairs Specialist
2 weeks ago
Boston, Massachusetts, United States Foundation Medicine Full timeAbout the RoleThe Senior Specialist, Regulatory Affairs plays a critical role in supporting the regulatory submissions process by developing regulatory strategies and submitting materials to health authorities such as the FDA for approval of novel platforms. This position provides regulatory guidance to internal development teams and prepares document...