Job Description:We are seeking a highly capable and innovative Freelance Medical Writer and Copy Lead to join our dynamic team. This role blends deep scientific understanding and excellent writing skills with an emphasis on medical communications across a diverse
Job Purpose: クローバルメディカルライティング及び国内マトリックスチームと協働し、規制当局に提出する承認申請資料、臨床試験の関連文書等の作成をリードする。関連法規、ガイドライン及び社内規定に従い、戦略的に、正確で科学的な文書を遅滞なく作成し、臨床試験の実施及び承認申請・取得に貢献する。また、効率的な文書作成プロセスを推進する。 Key Accountabilities/Responsibilities: 規制当局に提出する薬事文書の作成のリード:CTDの臨床・臨床薬理パート、対面助言資料、照会事項回答等 臨床試験に関連する文書の作成:治験実施計画書、治験総括報告書等 上記文書の作成におけるストラテジー・key messageの作成、文書作成のファシリテート、解析計画等の検討、スケジュールの作成及びCROマネジメント等 Basic Qualification: Skill CTD臨床パート、治験総括報告書、治験実施計画書等、承認申請や臨床試験に関連する文書の作成能力 社内外の関係者と円滑にコミュニケーションし、マトリックスチームをリードすることができる Global Medical Writing と協業するための英語でのコミュニケーションスキル ロジカルシンキング ダイナミックな変化のある状況下において、柔軟性・自発性をもって問題解決能力を発揮し、目標に向かって推進できる能力 臨床試験に関する基本的知識 生物統計学、薬物動態学に関する基本的知識 薬事規制、ICHガイドライン等に関する基本的知識 基本的なPCスキル(Word、Excel、PDF) Experience 製薬企業又はCROにおけるメディカルライティング業務経験(3年以上) Preferred Qualification: Skill 英文メディカルライティングスキル(治験総括報告書、治験実施計画書等) Experience 承認申請及び審査対応業務の経験(CTD作成、照会事項対応) 臨床開発業務又はそれに準ずる業務経験 複数部署の関係者で構成されるチームをリードした経験 Education/Certification/Language 薬学部または理学系学部卒以上 理学系修士または同等のもの。MD、PhD、PharmD(必須ではない) 職務内容および勤務地の変更範囲は会社の定めるところとする。
■ 職務内容 / Job Description Statistician(STAT) is an key player of coducting observational/database research in Medical division of AZ KK. Therefre, STAT surely plays the following roles. STAT directly reports to the director of Data Science, EOR.
Take lead in medical writing activities in authoring clinical/regulatory documents as well as submission requirements to obtain product approval. Align with global business strategies for local requirements Client Details * One of the top global biopharmaceutical companies in
■ 職務内容 / Job Description Medical Communication Scientist (MCS) is a role name in AZKK and is generally known as medical writer. MCS is responsible for the authoring of clinical-regulatory documents and submission packages that communicate the evidence
About Springer Nature Group Springer Nature opens the doors to discovery for researchers, educators, clinicians and other professionals. Every day, around the globe, our imprints, books, journals, platforms and technology solutions reach millions of people. For
Job Description Summary Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and local areas under the direction and agreement of the Group manager. Job Description Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Job Description Summary ・Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and local areas under the direction and agreement of the Group manager. Job Description Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and
Do you enjoy solving problems, writing software, and working with customers? Would you like to have more time to learn and work on Cloud Native apps, Data Analytics, and DevOps? Our team is looking for engineers who
Who we are looking for An individual who is energetic, collaborative, proactive and works well within a team. FX Operations Tokyo works closely with FX Sales Tokyo to support their business. As part of FX Operations
International SOS is the world’s leading medical and security services company with over 12,000 employees working in 1,000 locations in 90 countries. International SOS Government Services administers the TRICARE Overseas Program providing high-quality, accessible health care services
At Gensler, we design for people. We leverage our global perspective and local presence to innovate at every scale. We’re not just designers. We’re tinkerers, craftspeople, visionaries, innovators and thought leaders. Fueled by passion and entrepreneurial
City/State Elizabeth City, NC Overview Work Shift First (Days) (United States of America) As a Patient Care Specialist with Sentara Healthcare, you will provide non-clinical support within a physicians office and ensure an excellent patient experience
A Career at HARMAN As a technology leader that is rapidly on the move, HARMAN is filled with people who are focused on making life better. Innovation, inclusivity and teamwork are a part of our DNA.
Overall Purpose Of The Job The Senior Security Manager Assistance, North Asia, as a senior leader of a wider North Asia Medical and Security Assistance Services, plays as a key conduit in understanding clients’ needs and drive
Aviation Operations Integration Analyst Key Role Advise and assist on matters related to effective integration of Marine, U.S. joint and multinational aviation assets into operational plans and exercises in the Indo-Pacific theater of operations. Provide analysis
Job Description State Street’s Relationship Management/Sales Enablement organization is seeking to fill an APAC RFP & Sales Enablement, Officer role in Japan. The role will have exposure to the development of prospective/existing client strategy, assisting in
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is
Essential Responsibilities: The Coordinating Doctor provides clinical leadership and medical support to the 24 hour Assistance Centre combined with the running of medical evacuations and transport of patients. •Demonstrate an understanding of the differences in the scope of