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CMC Submissions Lead

Employer
Takeda
Location
Boston, Massachusetts
Start date
Nov 30, 2023

View more

Discipline
Science/R&D, CMC
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job Title: CMC Submissions Lead

Location: Cambridge, MA

About the role:

You will manage the Global CMC Regulatory Submissions preparation for Marketing Applications (e.g. NDA, MAA, BLA, JNDA) and Post-Approval Changes. You will work with cross-functional stakeholders in Regulatory, Global Manufacturing Sciences subject matter experts, Quality representatives, and other contributing functions to set up the framework for submissions in the Electronic Document Management System (EDMS) and support the submission preparation team members in its use. This is a hybrid role that reports to the Submissions Team Lead.

How you will contribute:
  • Maintain submission preparation timeline and manage submission readiness, finalization, and archiving of submisisons.
  • Receive Reg-CMC strategy and submission details sufficient to create timeline.
  • Collaborate with Reg-CMC and Content owners to prioritize and align deliverables.
  • Establish document structure in Electronic Document Management System (EDMS).
  • Create binders and applicable templates and maintain up to date during submission preparation
  • Support author management, content verification, and final quality check.
  • Provide support and lead meetings for kickoff, roundtables, content / data reconciliation, and follow-ups, as well as support RTQ process (e.g., Rapid Response Team).
  • QC, formatting, uploading, filing history, headers / footers, linking, and folder / vdoc structure.
  • Document management and legalization.
  • Support issue resolution and mitigation planning activities.
  • Initiate approval workflows and provide submission ready docs to publishing.

What you bring to Takeda:
  • BS/BA Degree in a Scientific Discipline required
  • Minimum 4 years experience in pharmaceutical or medical device industry in a relevant field, e.g. Regulatory CMC, Pharmaceutical Development, Analytical Development, Production, Quality Assurance.
  • Familiarity with global regulatory guidelines and experience in regulatory submission (CMC Module 3 information and QOS documents)

What Takeda can offer you:
  • Comprehensive Healthcare: Medical, Dental, and Vision
  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs and company match of charitable contributions
  • Family Planning Support
  • Professional training and development opportunities
  • Tuition reimbursement

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

  • Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
  • Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
  • Work in a cold, wet environment.
  • Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
  • Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

#GMSGQ #ZR1 #LI-MA1 #LI-Hybrid

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Company

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

For more information, visit https://www.takeda.com.

Stock Symbol: TAK

Company info
Website
Location
650 East Kendall Street
Cambridge
MA
02421
United States

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