Job purpose: Responsible for implementing the Medical Affairs Plan of specified Team strategies, driving a consistent approach to carrying out scientific engagement activities internally and in the field; ensuring compliance with all relevant regulations and GSK policy/code
Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world
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。
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 職務内容サマリ The primary focus of Medical Science is to lead medical educational event planning/implementing, contents creation, process standardization for new operating model for contents and publication and to measure and communicate the value of the
Job Responsibilities This position is part of the Global Supplier Management (GSCM) organization. In this position, you, the correct applicant will play a vital role with Technology Commodity suppliers. You will help establish/ sustain world class
ER24 SBMS Harmony Mponeng Mine | Carltonville | South Africa Closing date: 19/02/2024 Number of positions: 1 Recruiter name: Mina Van Der Merwe Reference number: 47998 Workplace Type: On-site Fixed Term Please note if you are
職務の目的および主な業務内容 Job Purpose & Key Responsibilities VEO Expertは、担当品目のValue Evidence Planの作成および実行に責任を持ちます。Evidence needsおよびGapを評価し、製品価値を高めるための最も適切な試験計画を組織横断チームにて立案し、提案していきます。 VEO Expert contributes to develop Japan Value Evidence Plan (J-VEP) of the assigned products. VEO Expert plan, implement and deliver high quality, scientifically robust research
Job purpose: Plan and execute the marketing strategy and tactics to ensure commercial success of the product Key responsibilities: To strategically drive “Shape the market” & “Shape the product”, work with Brand Lead to develop and
Job purpose Medical Science Liaison (MSL) is a field-based role in the new Medical and Development organization, reporting to MSL Head. In order to build a trust with External Experts (EE) and scientific community through, MSL needs to
Are you looking for your next “great mission” professionally? Do you feel like you have more to give, want to learn new skills and be part of a team with a rewarding mission supporting our Active-Duty
Are you looking for your next “great mission” professionally? Do you feel like you have more to give, want to learn new skills and be part of a team with a rewarding mission supporting our Active-Duty
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
Are you looking for your next “great mission” professionally? Do you feel like you have more to give, want to learn new skills and be part of a team with a rewarding mission supporting our Active-Duty
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
Are you looking for your next “great mission” professionally? Do you feel like you have more to give, want to learn new skills and be part of a team with a rewarding mission supporting our Active-Duty
The Opportunity: Avantor Fluid Handling (AFH) offers customized Single Use solutions that cater to the unique needs of biopharmaceutical manufacturers throughout the bioprocess workflow. The solutions include Masterflex peristaltic pumps, tubing, Single Use assemblies, and hardware.
Type of Requisition: Regular Clearance Level Must Currently Possess: Top Secret/SCI Clearance Level Must Be Able to Obtain: Top Secret SCI + Polygraph Suitability: Public Trust/Other Required: None Job Family: Information Security Job Qualifications: Skills: Information
Job Purpose: MSL Manager is accountable for leading and driving performance of MSL department in corresponding therapeutic area. MSL Manager drives MSL department by setting the right business objectives and priorities aligned with global counterpart to
Requisition #: 14356 Our Mission: Powering Innovation That Drives Human Advancement When visionary companies need to know how their world-changing ideas will perform, they close the gap between design and reality with Ansys simulation. For more
