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SpringWorks Therapeutics

Senior Regulatory Operations Publisher

SpringWorks Therapeutics, Stamford, South Dakota, United States,


Job Description

Job Description

About SpringWorks TherapeuticsSpringWorks 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:The Senior Regulatory Operations Publisher will be responsible for hands-on day-to-day global submissions support, as well as ensuring the timely and accurate publishing and submission of regulatory documents to health authorities. This role requires a strong understanding of regulatory publishing standards, attention to detail, multi-tasking, ability to collaborate with cross-functional teams.They will be responsible for all communications to and from global health authorities, partners, and CROs are logged and archived to the appropriate databases, systems, and/or repositories. In addition they will be responsible for participation in development of processes and tools to support all Regulatory activities and compliance.Key Responsibilities:Supports daily early-stage and post-marketing US and ex-US submissions activities, including (but not limited to) document formatting, PDF publishing, assembly and submission of Regulatory submissions to global health authorities.Supports cross-functional collaboration and resolve complex document issues.Provides oversight and participates in the maintenance of Regulatory Archiving activities. Duties include, but not limited to, archiving all health authority communications and submissions received from/to global health authorities (either directly or from SpringWorks Therapeutic affiliates).Contributes toward the development and implementation of department-wide SOPs, policies and/or work processes to streamline all submission activities and standardize interactions with other departmentsDevelop and provide training on Regulatory Operations processes and tools.Assists in formatting, editing, proofing, creating and manipulating complex tables, converting text and graphics, scanning, bookmarking and hyper linking.Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approvalPerform other duties and responsibilities as assignedQualifications:

Education: Bachelor's degree and/or equivalent work experience5+ years of Regulatory Operations, including publishing

IND/CTA/NDA/BLA/MAA/sNDA

eCTD and NeeS experience.Day-to-day use and knowledge of Regulatory systems (e.g., eCTD software, Veeva RIM, MS Word, MS Excel, SmartSheets, Adobe Acrobat / DXC Toolbox.Project management, decision making, problem solving, multi-tasking, working under shifting priorities and deadlinesEmbody 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.Compensation:The expected salary range for this position is $85,902.00 - $113,000.00. 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 also offer a comprehensive benefits package for our team of SpringWorkers and their families, including competitive compensation, annual cash bonuses and equity grants, 401K matching, fully covered medical, dental, and vision plans, and a full week of holiday break at year end. It's the right thing to do – and helps us be healthy, happy, and at our best for the people who need us.At SpringWorks, we believe in fostering a culture of belonging. Our Employee Resource Group's (ERG) mission is to boldly live the SpringWorks values, provide resources, and deeply engage SpringWorkers and the communities we serve to foster a culture of belonging. Ensuring diversity, equity, and inclusion are integral to our organization's DNA.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.GDPR Statement:

When you apply to a job on this site, the personal data contained in your application will be collected by SpringWorks Therapeutics ("Controller"), which is located at 100 Washington Blvd, Stamford CT 6902 and can be contacted by emailing

hr@springworkstx.com

. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards under the standard contractual clauses. You can obtain a copy of the standard contractual clauses by contacting us at

hr@springworkstx.com.Your personal data will be retained by Controller for as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.

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