Postdoctoral Research Fellow, Ironwood Pharmaceuticals-Global Patient Safety & Regulatory Affairs
Location: Boston, Massachusetts
Internal Number: 4605365
Postdoctoral Research Fellow, Ironwood Pharmaceuticals-Global Patient Safety & Regulatory Affairs
About the Opportunity
Northeastern University's Pharmaceutical Industry Fellowship Program is a two-year fellowship designed to advance the education and training of Pharm.D. graduates in various areas of industry pharmacy including regulatory affairs, medical information/affairs, patient safety, outcomes research, and many other areas. The program is a collaboration between Northeastern University and biopharmaceutical industry partners.
Our program provides a dynamic academic environment offering fellows the opportunity for a wide breadth of experiences:
Develop teaching skills through participation in our Teaching and Learning Seminar series
Facilitate small and large group didactic education in partnership with a faculty mentor
Create, present, and publish scholarly research through collaborative industry and university relationships
Engage with faculty who participate in various interdisciplinary
Network with area residents and other Northeastern fellows via professional development programs, teaching seminars, and participation on fellowship committees
In partnership with Northeastern University, Ironwood Pharmaceuticals is offering a two-year Global Patient Safety and Regulatory Affairs PharmD fellowship based in Boston.
Ironwood Pharmaceuticals (Nasdaq: IRWD), an S&P SmallCap 600 company, is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). LINZESS is also approved for the treatment of functional constipation in pediatric patients ages 6-17 years-old. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure (SBS-IF), as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs.
Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, and has operations in Basel, Switzerland.
The purpose of the Global Patient Safety and Regulatory Affairs (GPS/RA) Fellowship is to provide the fellow with training in both functional areas to prepare them to enter an industry role as an individual contributor in safety or regulatory after the end of their 2-year fellowship. The cross-functional collaboration between these two groups is essential to both the development of a therapeutic product and management of that product throughout its life cycle. By gaining experience in both functional areas, the fellow will be able to pursue a career in either function and allow them to have a practical understanding of the other function's responsibilities to enable them to be an optimal collaborator and colleague.
During the first year of the fellowship, the fellow will work within GPS to gain experience in case processing operations, safety database management, compliance, signal detection, signal management, aggregate reports, safety governance, and advanced pharmacovigilance analytics.
During the second year of the fellowship, the fellow will work within regulatory affairs to gain experience in global/regional labeling, maintenance of IND and/or NDA applications, regulatory strategy, regulatory intelligence, Agency meeting management and correspondence, and regulatory operations.
In both functions, the fellow will have the opportunity to work collaboratively with other functional areas within Ironwood including clinical development, medical scientific affairs, program management, data sciences, quality and compliance, nonclinical, medical writing and publications, and chemistry, manufacturing, and controls as well as experience partner interactions and engage in vendor oversight. Additionally, the fellow will have the opportunity to precept students, present guidance reviews, and other opportunities as they arise.
Global Patient Safety (Year 1)
Assist with pharmacovigilance (PV) operational and case management activities for safety reporting.
Participate in the maintenance of PV policies, procedures, and guidance documents to ensure compliance with all applicable regulatory requirements and guidelines, good PV practices and industry best practices.
Perform and/or support proactive safety monitoring and signal detection for assigned products.
Assist in and/or draft response documents to answer internal and/or external requests received by GPS.
Provide support for the cross-functional team responsible for overseeing the safety of Ironwood products
Maintain schedules, minutes, tracking sheets, and ensure follow-up of decisions and assigned tasks for relevant safety activities.
Assist in the preparation and/or presentation of safety governance presentation materials, signal assessments, and supporting documents.
Support the activities related to aggregate report preparation, risk management documents, and reference safety information.
Global Regulatory Affairs (Year 2)
Assist in the planning and coordinating all aspects of regulatory submissions necessary to support clinical trials, product registration, and postmarketing requirements (PMRs).
Assist in the development of regulatory strategies for assigned projects or product(s) across all phases of product development aimed at achieving marketing authorization and appropriate product labeling
Assist in planning, authoring, review and preparation of investigational new drugs (INDs), new drug applications (NDAs) and related annual reports, amendments, supplements, and maintenance of approved products.
Support the preparation for regulatory agency meetings for assigned products including meeting planning, developing briefing books, and ensuring submitted documents are compliant and of the highest quality.
Work with Regulatory Operations team to establish and meet timelines for regulatory submissions.
Keep abreast of and communicate changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictions.
Support and participate in the development of Regulatory Department systems and processes.
GPS/RA Department and Longitudinal Responsibilities
Assist with performance and compliance metrics for internal and external responsibilities.
Collaborate with internal teams and vendors to prepare for inspections and audits.
Precepting PharmD APPE students.
Present and assist in coordinating guidance reviews and other presentations.
Interact with partners and engage in vendor oversight as required.
Participate in fellowship recruitment activities and interviews.
Additional responsibilities to be assigned based on individual interests or as business needs require.
The Successful Candidate Will Provide:
Doctor of Pharmacy (PharmD) from an accredited college or university before the start of the fellowship term.
Extremely motivated to learn new skills and gain experience within both GPS and RA.
Ability to interpret and discuss regulations and guidelines related to drug development.
Ability to interpret and discuss medical, epidemiological, and clinical data and publications.
Ability to perform the assigned activities in full compliance with applicable regulations and internal procedures.
Ability to leverage a deep understanding of oneself through knowing one's strengths and weaknesses, proactively asking for feedback to balance self-perception, and being resilient in order to increase one's effectiveness.
Ability to work cooperatively with colleagues and take initiative to build relationships despite differences in interest, offering support and help to peers without being asked and proactively seeking input from others to solve problems.
Excellent interpersonal skills in order to effectively manage expectations and facilitate collaborative, working relationships.
Ability to recognize opportunities and/or issues and applying analytical and creative thinking to maximize performance.
Excellent written and verbal communication skills as well as organizational and project management skills, ability to multi-task in an extremely fast-paced environment with changing priorities.
Proficiency and experience with Microsoft Office Suite, especially Excel, Outlook, PowerPoint, and Word.
Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce
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 October 31, 2023
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 , 2023. 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 considers factors such as candidate work experience, education and skills when extending an offer.
Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation. Visit https://hr.northeastern.edu/benefits/ for more information.
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.
Founded in 1898, Northeastern University is a private research university located in the heart of Boston. Northeastern is a leader in worldwide experiential learning, urban engagement, and interdisciplinary research that meets global and societal needs. Our broad mix of experience-based education programs?our signature cooperative education program, as well as student research, service learning, and global learning?build the connections that enable students to transform their lives. The University offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in nine colleges and schools.