Leads and manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development (e.g., program level standards), trials (e.g., CSRs), and filings (e.g., clinical modules)
Solves complex problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve
Generate complex clinical study related documents, including protocols, protocol amendments, informed consent forms, Investigator Brochures, study manuals and clinical study reports to support Karyopharm clinical development programs. This will include generating questions about technical content, identification of key subject experts to address the questions and providing informed updates to the documents.
Interprets and applies knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines
Manage review and approval of clinical study-related documents
Provides leadership for medical writing processes, standards, and innovative initiatives
Contribute to generation and maintenance of templates and standard text for clinical documents
Contribute to generation and review of SOPs relating to generation of clinical study documents
Significantly contribute to discussions regarding document content, informed by review of pertinent publications, guidances and/or discussions with outside experts
Provide quality review as necessary for clinical and regulatory documents
Provide document support as needed to Regulatory Affairs
Provide protocol and clinical document support for investigator-sponsored clinical studies
Provide document support for preclinical programs as necessary, including drafting of publications and presentations
Provide training and guidance to other medical writers, providing scientific and operational mentorship and coaching in the design, planning, and execution of their assignments
Minimum of 10 years of Medical Writing experience with evidence of increasing responsibility/technical development
B.S. or equivalent degree in a scientific area. Advanced degree (MS or PhD) preferred
Knowledge of regulations relevant to medical writing
Ability to assess workload and suggest prioritization to senior staff
Demonstrated abilities in collaboration with others and independent thought
Proficient in use of Microsoft Word, Adobe Acrobat, Microsoft Powerpoint and Please Review software. Ability to work on several projects at once while balancing multiple and overlapping timelines
Careful attention to detail and accuracy
Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally
This position is an onsite role, however, we will consider remote candidates located in the eastern part of the U.S. who are willing to be onsite on a monthly basis.
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.
Associated topics: care, family, family medicine, family medicine physician, family practice, general practice, outpatient, physician, primary, primary care
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.