Postdoctoral Research Fellow
Founded in 1898, Northeastern is a global research university and the recognized leader in experience-driven lifelong learning. Our world-renowned experiential approach empowers our students, faculty, alumni, and partners to create impact far beyond the confines of discipline, degree, and campus.
Our locationsin Boston; Charlotte, North Carolina; London; Portland, Maine; San Francisco; Seattle; Silicon Valley; Toronto; Vancouver; and the Massachusetts communities of Burlington and Nahantare nodes in our growing global university system. Through this network, we expand opportunities for flexible, student-centered learning and collaborative, solutions-focused research.
Northeastern's comprehensive array of undergraduate and graduate programs in a variety of on-campus and online formatslead to degrees through the doctorate in nine colleges and schools. Among these, we offer more than 195 multi-discipline majors and degrees designed to prepare students for purposeful lives and careers.
About the Opportunity:
Vertex Pharmaceuticals Incorporated
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. In addition to clinical development programs in the respiratory, nephrology, pain, and cell and gene therapy disease space, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other rare 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.
At Vertex, we have some of the industry's best and brightest people helping us achieve our mission of discovering transformative medicines to help people with serious diseases. We depend on a talented global workforce to lead the charge as we work toward developing tomorrow's breakthrough medicines. The broad background possessed by a Pharm.D. graduate is highly valued in the Biopharmaceutical Industry, and certainly here at Vertex.
Vertex is offering a 2year Biopharmaceutical Industry Fellowship in Medical Writing Science at the corporate headquarters in Boston, MA. The Medical Writing Science (MWS) department has a critical role in the full lifecycle of our drug products. The department includes Medical Writing Scientists and MWS Operations Specialists, all who have diverse scientific backgrounds. During the fellowship, the Pharm.D. fellow will work closely with Medical Writing Scientists to utilize their knowledge and skillsets to be strategic partners and peers to other departments within Global Medicine Development & Medical Affairs (GMDA), Global Regulatory Strategy, Preclinical Sciences, and Research. The Pharm.D. fellow will utilize their scientific acumen, project management skills, and leadership to develop clinical and regulatory documents in partnership with crossfunctional stakeholders. This training, along with crossfunctional interactions, will provide a cumulative set of skills and a broader understanding of drug development.
Apply scientific knowledge, analytical skills, and strategic thinking to lead the development of clinical and regulatory documents
Develops routine clinical and regulatory documents, including clinical study protocols, clinical study reports, investigator's brochures, and sections of regulatory submissions in partnership with crossfunctional stakeholders
Provide Medical Writing Science expertise to support clinical study execution and closeout
Provide expert review of documents authored by other functions (e.g., protocol deviation plans, statistical analysis plans, clinical pharmacology analysis plans, and clinical study postings)
Review clinical study data and provide recommendations on data presentation to crossfunctional team
Serve as a subject matter expert for data presentation and overall structure of clinical and regulatory documents to ensure adherence with Vertex standards and regulatory guidelines
Provide project management of document timelines and communicate expectations, milestones, and deliverables of document development to crossfunctional team
Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts.
Excellent oral and written communication, time management, and leadership skills, ability to work independently and take initiative on a variety of projects at the industry site and Northeastern.
Applicants should submit the following APPLICATION MATERIALS by the priority deadline of November 1st , 2021:
Curriculum vitae (CV), uploaded
Unofficial PharmD transcripts, uploaded
Cover letter, uploaded
Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 29th, 2021. LOR writers should include the candidate's name and fellowship program(s) in the subject line (e.g. Smith, John - Alnylam, GSK).
Address cover letter and three LORs to:
J. Andrew Orr-Skirvin, PharmD, BCOP
Clinical Professor, School of Pharmacy
Chair, Department of Pharmacy & Health System Sciences
Director of Pharmaceutical Industry Fellowship Program
360 Huntington Ave, 140TF R218
Boston, MA 02115
Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff. Northeastern values and celebrates diversity in all its forms and strives to foster an inclusive culture built on respect that affirms inter-group relations and builds cohesion.
All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.
To learn more about Northeastern University's commitment and support of diversity and inclusion, please see www.northeastern.edu/diversity.
To apply, visit https://careers.pageuppeople.com/879/cw/en-us/job/507799