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Sunovion Global Regulatory Affairs Intern in Marlborough, Massachusetts

This summer internship will offer college and university students an outstanding opportunity to gain hands on experience within the pharmaceutical industry. This program allows students to work closely with business leaders while acquiring industry insight. Interns will be tasked with both individual and group projects. The Sunovion Internship Program will offer additional workshops and seminars for your career and professional development. We are seeking dedicated individuals within multiple areas across the organization.

Specific Internship Description:

This internship will be crafted with the business need and candidate interest in mind but could include any of the following:

  • Understand all aspects of Global Regulatory Affairs

  • Help plan, process, and review Regulatory submissions prior to dispatch to the health authority

  • Learn the process used to write and publish clinical documents

  • Be exposed to the strategies used when interacting with the health authorities for clinical trial applications (INDs, CTAs) and marketing approvals (NDAs, MAAs).

  • Compile, publish, and validate submissions in accordance with regulatory agency specifications and standards

  • Work with Global Regulatory Leads in the assessment of clinical trial and marketing approval applications (INDs, NDAs, CTAs, MAAs, etc.)

  • Write and edit medical writing deliverables across multiple phases of clinical research

Learning Goals:

  • The intern would be provided with exposure to three groups within Sunovion's Regulatory department: Regulatory Affairs, Regulatory Operations and Medical Writing.

  • Gain insight into the Regulatory side of the pharmaceutical industry

  • Enhance communication skills by working with vendors and cross-functional team members

  • Develop familiarity with the electronic common technical document (eCTD)

  • Develop project management skills by planning submissions to health authorities

  • Understand the basic fundamentals and concepts of the Regulatory Operations publishing process

  • Publish and QC clinical documentation used in Regulatory Submissions and applications

  • Gain expertise in the processing of promotional materials to the office of Prescription Drug Promotion (OPDP)

  • Learn about the software and systems used in processing Regulatory submissions (e.g. Veeva, Adobe)

Minimum Requirements:

  • Enrolled in PharmD degree program

  • Must have completed their second year (P2) of study by Summer 2023

  • Authorization to work in the U.S. without requiring sponsorship

  • Experience using Microsoft Office (Excel, PowerPoint, Word.)

  • Strong communication skills and passion for continued development

  • Covid-19 Vaccinations are required

Program Details:

  • Position will begin on Monday June 5, 2023

  • Position is located remotely in the US

  • Position is full-time Monday through Friday – up to 40 hours per week

  • Candidates should be available to commit to 10 weeks

Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious Central Nervous System (CNS) conditions. Sunovion’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. The Company has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with Central Nervous System (CNS) conditions.

Health and Safety: To maintain the health and safety of our employees, patients, and affiliates, as well as comply with the vaccination requirements of our partners, employees are required to be vaccinated against COVID -19. Candidates hired must provide proof of vaccination against COVID-19 within 5 days post hire as a condition of employment. In accordance with Equal Employment Opportunity laws, exemptions for religious and medical reasons will be considered.

Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.

Mental/Physical Requirements : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer

Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

For more information about EEO and the Law, please visit the following pages:

Equal Employment Opportunity is THE LAW (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEO is the Law Poster Supplement

Pay Transparency (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

Lead the way to a healthier world by putting patients at the center of everything we do

We are focused on developing innovative therapies and transforming the lives of people with serious medical conditions. We are creating innovative psychiatric, neurological and respiratory therapies that help transform people's lives, while at the same time we are playing an increasingly active role in the future of global health.

Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer. Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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