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Postdoctoral Research Fellow, Ironwood Pharmaceuticals--Global Patient Safety & Regulatory Affairs
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Position Number: 5636778
Location: Boston, MA
Position Type: Business - Management

Postdoctoral Research Fellow, Ironwood Pharmaceuticals--Global Patient Safety & Regulatory Affairs

About the Opportunity

About the Opportunity:

Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm.D. graduates. Critical to the success of the program is our ability to prepare Fellows to meet the ongoing workforce needs in various areas of industry.

Our program gives fellows an opportunity to work with our innovative biopharmaceutical industry partners while collaborating with Northeastern University faculty in professional and career development, service, scholarship, and teaching.

In partnership with Northeastern University, Ironwood Pharmaceuticals is offering a two-year Global Patient Safety and Regulatory Affairs PharmD fellowship based in Boston.

Company Summary:

Ironwood Pharmaceuticals 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), which is the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) and is also indicated 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. With a seasoned GI leadership team at the helm, deep relationships within the GI community, and a proven track record of success, we are poised to unearth new opportunities to create next-generation GI advancements.

Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, with a site in Basel, Switzerland.

Responsibilities:

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, 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.

Qualifications:

Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the US.

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.

Additional Information:

Applicants should submit the following APPLICATION MATERIALS by the priority deadline of October 31st, 2024.

Curriculum vitae (CV), uploaded

Unofficial PharmD transcripts, uploaded

Cover letter, uploaded

Letter of intent describing why the candidate would like to join Ironwood's Fellowship program.

Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 22nd, 2024. 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

Position Type

Research

Additional Information

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.

To learn more about Northeastern University's commitment and support of diversity and inclusion, please see www.northeastern.edu/diversity.

To apply, visit https://northeastern.wd1.myworkdayjobs.com/en-US/careers/job/Boston-MA-Main-Campus/Postdoctoral-Research-Fellow--Ironwood-Pharmaceuticals--Global-Patient-Safety---Regulatory-Affairs_R127564