Karyopharm Therapeutics Inc. Senior Medical Writer in Newton, Massachusetts
The main responsibility is to independently author complex regulatory and safety documents ensuring the coordination and integration of scientific, clinical and regulatory input from cross functional team members.
Specifically lead the writing of complex clinical documents (e.g. protocols, protocol amendments, phase II/III clinical study reports, high level summary documents), and certain non-clinical documents (e.g. initial Investigator’s Brochure and safety update reports).
Organize and lead meetings with study team members to determine timelines and processes for the assigned regulatory documents.
Ensure key messages within the document and across the program are clear and consistent.
Adhere to Karyopharm style guide for formatting and usage.
Manage documents through the review process (coordinating document review meetings, collate and reconcile comments from various functional groups) and the approval process.
Provide guidance/solutions for medical writing processes, standards, and innovative initiatives.
Contribute to generation and maintenance of templates and standard text for clinical documents
Critically reviews project specific data, outputs and shell reports; organizes meetings to get team consensus on document planning and maintain decision trail.
Provide quality review as necessary for clinical and regulatory documents.
Provide document support as needed to Regulatory Affairs
Provide training and guidance to other medical writers, offering scientific and operational mentorship and coaching in the design, planning, and execution of their assignments.
Has more than 5 years of Medical Writing experience in a CRO/biopharmaceutical industry
B.S. or equivalent degree in life sciences. Advanced degree (MS or PhD) preferred.
Must have strong interpersonal skills needed to work in a team environment.
Able to work independently; meet deadlines, demonstrate effective use of time, and handle multiple assignments simultaneously
Understands clinical drug development process, including clinical trial design, operations and results analysis
Knowledge of regulatory guidances relevant to medical writing.
Excellent oral and exceptional written communications with ability to present data to all levels of audiences.
Proficient in use of Microsoft Word, Adobe Acrobat, Microsoft PowerPoint and other standard software used for data analysis and writing of regulatory documents.
Careful attention to detail and accuracy
Prior experience of clinical trial disclosure process or oncology therapeutic area is a plus.
Karyopharm Therapeutics is a global commercial-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department.
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