Job description
About SpringWorks Therapeutics:
SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany, is a commercial-stage biopharmaceutical company dedicated to improving the lives of patients with rare tumors.
We developed and are commercializing the first and only FDA and EC approved medicine for adults with desmoid tumors and the first and only FDA and EC approved medicine for both adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN).
At SpringWorks, we are committed to finding answers people with rare tumors need. We thrive in an atmosphere of passion and tenacity, fueled by the excitement of the possibilities science may unlock and driven to work with urgency because of the importance of our work. We value authenticity because diverse backgrounds, cultures, styles and abilities can only help us find the answers that people with rare tumors are looking for .
Your Role:
The Senior Medical I Writer will have the primary responsibility for leading the preparation of all clinical trial documents including protocol synopses, full protocols, and clinical study reports, as well as clinical and nonclinical summary modules for INDs, NDAs, regulatory documents such as briefing books etc. May also develop scientific publications and other external documents such as scientific abstracts and manuscripts. Leads execution of medical writing projects coordinating the contributions of the cross functional team, managing timelines, Veeva flows to ensure the timely and efficient delivery of study documents.
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. #LI-Remote
Essential Duties and Responsibilities:
- Leads development of clinical and nonclinical documents that are submitted to regulatory authorities including but not limited to investigator brochures, study protocols, model informed consents, interim and final clinical study reports (CSR), module 2 documents, and regulatory documents such as briefing books etc.
- Produces complex clinical or scientific documents, such as, IBs, and sections of INDs, NDAs, CTDs, and dossiers.
- Responsible for positioning information and data for presentation of clinical, pharmacokinetic, pharmacodynamic and statistical written materials. Leads compilation of CSR appendices including data displays and clinical narratives.
- Provides detailed medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
- Ensures document content and style adheres to EMEA/FDA or other appropriate regulatory guidelines and complies with departmental SOPs and style guidelines.
- Performs literature searches and reviews as necessary to obtain background information and provide literature references.
- Responsible for development of medical writing SOPs and style guidelines.
- Manages the timeline for the preparation of the documents, creating details processes, setting up kick off meetings and comment resolution meetings, owns workflows in Veeva
- Perform other duties as assigned
Role Requirements:
- Education: Bachelor’s degree or equivalent in a scientific discipline, advanced degree preferred
- At least 7 years’ experience in regulatory writing and knowledge of preparing documents to ICH standards.
- Prior experience within the Pharmaceutical or CRO industry
- Strong scientific and/or medical writing knowledge preferred
- Ability to lead writing and compilation of clinical documents
- Ability to influence and drive key decisions and stakeholders within a project team
- Strong understanding of pharmaceutical industry procedures and regulations
- 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.
Compensation & Benefits:
The expected salary range for this position is $114,000.00 - $150,000.00. 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 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.
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.
Privacy:Upon submission of this form I understand that SpringWorks Therapeutics is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S.. Information about SpringWorks Therapeutics’ privacy practices can be found at Privacy Policy - Springworks (springworkstx.com).
