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Daiichi Sankyo, Inc. is the U.S. subsidiary of Daiichi Sankyo, Co., Ltd. The Company currently markets therapies in hypertension, dyslipidemia, diabetes, acute coronary syndrome, thrombotic disorders, stroke risk reduction, opioid-induced constipation, IV iron therapy and metastatic melanoma.
Position is responsible for the preparation of protocols, Investigator Brochures (IBs), Clinical Study Reports (CSRs), clinical sections of the CTD (2.5, 2.7.3, 2.7.4), integrated summaries of efficacy and safety (ISE and ISS), briefing books, and regulatory responses. The position will be responsible for hands-on writing as well as supervision of work performed by CRO/consultant writers on complex projects, and develop medical writing processes and working standards. Documents must be of high quality in terms of scientific content, organization, clarity, accuracy, format and consistency, and adherence to regulatory requirements and company guidelines/styles/processes. In addition, this position has the potential to be a lead writer for protocols, reports, and IBs. As a content expert, this position has a significant understanding of regulatory requirements and ICH guidelines (including E3 and E6), and basic knowledge of document management systems.
1. Serves as primary author on a wide variety of clinical documents (protocols, reports, investigator brochures, etc), with guidance as needed from functional area experts. Coordinate and control medical writing activities of external writers with regards to company document templates, standards, and processes; Critically review documents produced by external writers for scientific content and alignment with company position, clarity, accuracy, and consistency; Act as liaison between internal and external reviewers and the external writer; Organizes and leads cross-functional meetings to determine timelines and processes for protocol and report development; Addresses QC findings on documents with minimal input from functional area experts 2. Writes high-quality first-draft content with minimal input from functional area experts; Understands clinical data and uses text, tables, and figures as appropriate to accurately and effectively convey key messages; Participate in appropriate development teams and internal strategy and operations meetings 3. Serves as main point of contact with CRO or contract medical writer on complex projects; Ensures that documents written externally conform to company standards and style 4. Develops medical writing processes and working standards; Uses knowledge of document development best practices to continuously improve medical writing SOPs, templates, style guide, etc. 5. Provide independent document quality control services for documents on which the writer has no other role; Check electronically published CSRs for completeness (appendices and required signatures present) and adherence to company's electronic publishing standards before archiving
Education and Experience
Minimum 2-5 years of experience with a Master's of Science degree or PhD or
Minimum 5-7 years of experience with a Bachelor's degree
Regulatory medical writing experience required
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Lead Medical Writing
City Basking Ridge
Functional Area Clinical Development Operations
State New Jersey Associated topics: ballroom, cooking, driving, equestrian, extracurricular, gardening, piano, summer, violin, voice
* 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.