Projektbeschreibung
Job Summary: We are currently seeking a Associate Director, Medical Writing for our Edison, New Jersey location. This 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. 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. The position will assist the Director or act as the Director's designee for work related to document templates, document SOPs, and training DS employees and CROs on these topics. The position will be the Director's designee for interdepartmental meetings and meetings with alliance partners as needed. The position will mentor more junior staff (the medical writing Manager and any in-house temporary employees) as needed. Responsibilities: In this role, you will 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. Assist Clinical Study Managers with managing documents through the review process (coordinating document review meetings, collate and reconcile comments from various functional groups) and the approval process. Assist document approvers with using Documentum to provide electronic signatures. Provide medical writing support for development programs by hands-on writing of protocols, IBs, and other documents. Participate in appropriate development teams and internal strategy and operations meetings. Work with the Director on document SOPs and templates and associated roll-out training. Mentor junior staff. Serve as Acting Director in case the Director is unavailable. 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. Qualified candidates must have a PhD in biological sciences or MD. Minimum requirement of 6 years experience in writing regulatory documents (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) in the pharmaceutical or CRO environment; ability to interpret and organize scientific data; and general understanding of clinical research, biostatistics, electronic publishing, and relevant industry guidelines (GCP, eCTD, and ICH). Marketing submission experience (NDAs or MAAs) required. Daiichi Sankyo develops or has developed drugs in the following therapeutic areas: cardiovascular diseases, metabolic diseases, inflammation and immunology, infectious diseases, and oncology. Relevant therapeutic area experience preferred. Ability to quickly get up to speed on a therapeutic area, project, or indication with little to no coaching, work concurrently on several complex projects, meet aggressive deadlines, and adjust priorities rapidly as the situation demands. Strong interpersonal and communication skills (both verbal and written) are also required as the individual must be able to work in a team environment and coordinate with the team to move documents forward to completion. Ability to mentor/coach more junior writers and act decisively on behalf of the Medical Writing group in the Director's absence. Must be a self-motivated person who can work with limited guidance/supervision. Excellent writing skills with a clear concise style and excellent grammar, punctuation, and spelling; proficiency in a Microsoft Windows environment; and strong MS Word skills and ability to work with templates. Excellent attention to details, especially as related to accuracy of numbers/statements and consistency within and across documents.