Vertex Pharmaceuticals

Vertex Pharmaceuticals Boston, MA, USA
May 12, 2019
Full time
Job Description The Sr. Manager is responsible for developing and implementing innovative regulatory strategies in support of various projects and sub-teams. As a Regional Regulatory Lead, the Sr. Manager is responsible for planning and coordinating all aspects of regulatory submissions necessary to support clinical trials, product registration and life cycle management in their region and is the main point of contact for Regulatory Authorities for an assigned project. KEY RESPONSIBILITIES: • Responsible for specified regulatory deliverables for multiple development programs, working with the Global Regulatory Lead, cross-functional stakeholders and consultant(s), as needed • Represent GRA on cross-functional teams, such as study execution teams, clinical development task-forces and commercial sub-teams, as the regulatory subject matter expert for that region • Develop, drive and coordinate regulatory timelines, working closely with the Global Regulatory Lead and other key stakeholders • Work with the Global and Regional Labeling Lead to support the development of the regional labeling strategy • Prepare, review and/or approve regulatory submission documents and regulatory authority communications • As the Regional Regulatory Lead, serve as the main point of contact with regulatory authorities, and lead region-specific regulatory authority interactions • Ensure compliance of regulatory strategies and submissions with current regulations and guidance • May serve as point of contact with contractors and corporate partners, where relevant, for specific projects • Contribute to the continuous improvement of existing department processes and strategies, providing recommendations in their area of expertise MINIMUM QUALIFICATIONS: • Bachelor's degree in relevant scientific discipline, higher degree desirable PREFERRED QUALIFICATIONS: • Ph.D. (or equivalent degree) and 4+ years of relevant work experience, or • M.S. (or equivalent degree) and 6+ years of relevant work experience, or • B.S. (or equivalent degree) and 8+ years of relevant work experience • Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance - preferably from at least both US and EU • Regulatory knowledge in a number of therapeutic areas and with drug-device combination products • Ability to effectively collaborate with internal and cross functional colleagues at all levels of the organization to achieve business objectives • Strong written and oral communication, listening, and non-verbal communication skills • Able to provide regulatory leadership on a cross-functional team and work effectively in a matrix environment • Capable of strategic thinking and proposing innovative solutions to regulatory problems • Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development • Actively pursues innovation and excellence and is able to motivate others to pursue these values. • Capable of leading significant general projects for the function, including due diligence activities Company Information Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit . Vertex 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, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. 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 make a request to the recruiter or hiring manager, or contact Talent Acquisition at . Req ID 10527BR
Vertex Pharmaceuticals Boston, MA, USA
May 01, 2019
Full time
We seek an accomplished and innovative scientist ideally with expertise in the field of hemoglobinopathies. Both a scientific and strategic leader, this individual will drive the internal Vertex research strategy towards the discovery of therapies to treat sickle cell disease and beta-thalassemia. Specifically, the ideal candidate will serve on the cross-functional Disease Strategy Team overseeing internal research and development programs as well as external collaborations with industry and academic partners. The ideal candidate will have broad experience in both small molecule and nucleic acid therapeutics for the treatment of hematological disorders, however this is not a requirement. This position will report directly to the Head of Boston Research. Key Responsibilities: Provide creative and innovative leadership to the Disease Strategy Team to drive the overall approach both strategically and scientifically Advise cross-functional teams supporting the disease area including early research, preclinical and development Ensure effective interaction & communication between the Disease Strategy Team and the program teams, Executive Committee and other key stakeholders Minimum Qualifications : PhD or MD/PhD in Biology, Hematology or equivalent with >10 years experience in area of expertise Willingness to learn and master new areas of disease biology Experience in both small molecule and nucleic acid therapeutics is a plus but not required An extensive track record of presentations, publications, and patents Proven success in driving cross functional teams toward a common goal and deliverables A high degree of self-motivation, organization, communication, and presentation skills; high competence in solving complex problems, as well as the ability to navigate a fast-paced cross-functional and collaborative work environment A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston's Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 2,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry's top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards. For additional information and the latest updates from the Company, please visit . Vertex 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, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. 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 make a request to the recruiter or hiring manager, or contact Talent Acquisition at .
Vertex Pharmaceuticals Boston, MA, USA
May 01, 2019
Full time
Vertex is seeking a talented individual to join our Analytical Development - Process Analytical Technology group in Boston, MA. As a member of the Process Analytics and Control team, this individual will also be a member of the industry leading continuous drug product manufacturing team supporting drug development programs at Vertex. The role will focus on both on-site support of GMP continuous manufacturing and PAT model development. Specific responsibilities include compliance to cGMPs, the development and validation of Process Analytical Techniques (PAT) methods and data models, statistical data analysis including the justification for sampling plans, Monte Carlo simulations, etc., and the evaluation of new technology to support Formulation Development, Continuous GMP Manufacturing and Real Time Release Testing (RTRT). Leading and executing GMP activities in continuous manufacturing is critical to the role. Key Responsibilities: Supporting the development and validation of automation control software related to continuous manufacturing. Supporting GMP continuous manufacture. Presenting to cross functional teams and effectively communicate critical issues and solutions Developing PAT methods (NIR, Raman, particle size) and data models to support unit manufacturing operations. Implementation of PAT methods/models for real time in-process controls and real time release testing Interfacing with key CMOs to generate PAT data during early development for key unit operations (blending, drying, etc). Transfer and validation of methods/models for unit operations to allow for application to continuous manufacturing. Authoring and reviewing documents required for a cGMP environment. Minimum Qualifications : Ph.D. degree in the physical sciences, mathematics or engineering or equivalent experience Minimum Experience: 0 - 5 years (PhD). Pharmaceutical Industry experience is an asset, but is not required. Experience with statistics, chemometrics, programming and data modeling packages such as Matlab, Unscrambler, Eigenvector PLS Toolbox, etc. Experience with programming (SQL, .Net, XML, C#, etc.), automation, databases, configuring SQL reports is a plus but not a requirement The ability to work successfully in both a team/matrix environment as well as independently is essential The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects is essential Excellent written and verbal communication skills as demonstrated by symposia presentations and research publications in peer reviewed journals are essential Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston's Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 2,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry's top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards. For additional information and the latest updates from the Company, please visit . Vertex 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, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. 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 make a request to the recruiter or hiring manager, or contact Talent Acquisition at .