About SpringWorks Therapeutics:
SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.
About the Role:
Regulatory Information Management (RIM) Director is responsible for overseeing, improving and managing Veeva RIM system. This role involves leading the strategy of managing regulatory submissions, tracking product lifecycle data, and optimizing the use of regulatory system. The Director will collaborate closely with internal and external teams, including Regulatory, IT, Quality, Safety, Biometrics, Clinical and others.
Location Classification – Remote:
Officially classified as working full-time from employee’s home office within the United States or respected region, with the expectation to travel to SpringWorks Therapeutics offices or other locations on occasion as business needs
Key Responsibilities:
- Drive all Veeva RIM features enhancements and work closely on the business needs with Regulatory Operations team lead.
- Oversee Veeva RIM Releases. Work closely with Veeva Manage Services (MS).
- Develop and execute comprehensive training for the global teams. Write SOPs and training materials for Veeva RIM.
- Provide daily support to Veeva RIM users.
- Drive new implementations that improve efficiency and compliance.
- Provide document-level support to ensure documents development and archive goes smoothly.
- Collaborate with IT, QA and external vendors to enhance system capabilities and resolve issues. Perform technical tasks as needed.
- Ensure that Veeva RIM works properly for regulatory submissions and archive.
- Stay informed of industry trends and global regulatory technology advancements to implement the best practices.
- Perform other duties and responsibilities as assigned
Qualifications:
- Education: Bachelor’s Degree or relevant years of experience
- 9+ years related industry experience with a Bachelors’ degree; or 7 years of experience with a Master’s degree; or 4 years of experience with a PhD
- Experience managing Veeva RIM and EDMS required
- Knowledge and demonstrated experience in relevant US/EU/ICH Regulations (e.g., eCTD format, GxP regulations), Regulatory publishing tools, and IT/EDMS systems (e.g., maintenance and/or implementation)
- Experience in 21 CFR Part 11 compliance/other electronic registration systems requirements
- Should have intermediate knowledge of Veeva PromoMats and Quality. Other Veeva suites are a plus. Microsoft Office 365, Azure (top level), FileZilla, SmartSheets, Adobe Acrobat, and other EDMS systems
- Experience working with managed services and/or offshore teams
- Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams’ performance.
- Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
- Ability to travel occasionally including overnight stay driven by business need.
- This position must be able to work East Coast hours. #LI-Remote
Compensation:
The expected salary range for this position is $184,164.00 - $242,500.00. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.We offer best-in-class benefits for our team of SpringWorkers who work with urgency on behalf of patients suffering from devastating diseases. Interested in learning more, review additional information here Benefits.
SpringWorks Leadership Principles:
- Change Steward - Recognize that change is essential; set goals that align to the Company’s strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever changing requirements
- Excellence Driver - Drive high performance and ownership through an open dialog; recognize performance, empower teams and create accountability for results
- Growth Coach - Set clear expectations, provide frequent feedback, coaching, and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers
- Community Builder - Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse, inclusive, and psychologically safe environment
DE&I:
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DE&I
EEO Statement:
SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks’ Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.
This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.
For more information see our Privacy Policy - Springworks (springworkstx.com)
