メディカルライティング　シニアマネージャー・マネージャー

職種

• 医薬品メディカルライター

仕事内容

The Role： We are looking for a highly motivated, independent and talented Medical Writing Manager/Senior Manager. In this role, you will be responsible for driving, developing, and writing clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. As Medical Writing Manager/Senior Manager, you will be responsible for ensuring that scientifically robust messages and arguments are developed and conveyed consistently across documents. Ideally, you will have an academic degree in life sciences with a broad background that has given you a solid knowledge on clinical drug development and regulatory requirements. The successful candidate will have strong analytical skills, high quality standards and is committed to meet deadlines. In addition, it is essential the candidate is well-organized, proactive, and flexible, and has the ability to work on multiple tasks simultaneously with a team-player mindset. We offer a position where you will be involved in strategic project, as well as trial-related activities, and will have ample opportunities, responsibilities, and influence on defining your own work. You will also be involved in developing processes and tools to support further development of the department.

求める能力・経験

• At least 5 years (Manager) or 7 years (Senior Manager) relevant medical or scientific writing experience in the pharmaceutical industry. Oncology experience preferred, but not required if the candidate has demonstrated experience in other indication[s]. • Experience authoring clinical components in regulatory filings (NDA)(highly preferred) Familiarity with all phases of drug development processes (discovery to market), clinical trial protocol design, CTN submissions, investigator’s brochures, plans required for the conduct of clinical trials, and clinical trial data collection and results

雇用形態

給与

900万円〜1,500万円

勤務時間

休日・休暇

社会保険

備考

配属先

転勤

住所

東京都港区

制度

その他

制度備考