製薬 × メディカルアフェアーズ の求人情報一覧
-
NEW求人番号：Job-00228655 掲載日：2023-03-27
Medical Advisor (Diabetes)
Rich pipeline1500 - 2000 万円 関西 製薬 メディカルアフェアーズ
- 会社概要
- 同社はグローバル規模の医薬品・臨床研究の企業です。
- 業務内容
- <職務内容>• 臨床開発医師（CRP）は、臨床現場や基礎研究などでの経験や専門性を通して、その医学専門家として日本イーライリリーの臨床開発やMedical affairs活動に対して強いリーダーシップを発揮することが期待される。• CRPは新薬の開発早期から、全開発期間、承認/上市/市販後と薬剤ライフサイクルのすべての時期において医学専門家の観点から以下のような行動が期待される 新薬の臨床開発業務を、関連各部署のメンバーと協力しながらリード/サポートする。 臨床試験実施のサポート、申請資料作成のリード、薬事業務のサポート、関連するThought Leadersからの意見聴取や情報共有を通した関係構築のリード、科学的データの公表のリードなど 米国本社チームメンバーとの密接な協力関係をリードする。 開発中の新薬の上市を視野に入れ、上市後の準備活動（環境整備を含む）を医学専門家の観点からリードする。 Medical Event（アドバイザリーボード会議、Scientific Interviewなど）の計画立案、実施 外部顧客に対するMedical education活動(Scientific Exchange Meeting, Health Education Meeting, Med Ed Web Siteの管理、コンテンツ作成など)の戦略立案、実施 当該薬剤に関する科学的エビデンス作成（Real World Evidenceなど） 当該薬剤に関する学会発表、論文作成（Thought Leaderの先生方との協働を含む） 外部顧客（Thought Leaderの先生方を含む）との当該薬剤に関する様々なディスカッション 外部顧客からの医学的科学的な質問に対する対応（回答作成、訪問説明など） ブランドチームの一員として、市販後の製品価値向上のための戦略策定、セールス/マーケティングチームの様々なビジネス活動をサポートする。 ブランド戦略作成のためにマーケティングチームとの協働マーケティングツールに対するメディカルレビュ
Emely Motol
Pharma -
NEW求人番号：Job-00235458 掲載日：2023-03-27
【東京】薬制薬事担当者
製薬業界での経験をお持ちの方必見です。600 - 1100 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 同社は、医薬品の研究、開発、製造、販売および輸出を行っています。
- 業務内容
- 薬制薬事担当者としてご活躍いただきます。GMP/QMS/GCTP適合性調査（承認前調査/定期調査）
外国製造業者認定の維持・管理
委託先への製造・試験法に関する調査（承認書と製造実態の整合性に係る年次点検、日局改正対応状況の確認、等）
Patrick Chang
Pharma -
求人番号：Job-00213087 掲載日：2023-03-20
Medical Information Specialist/Mangger
医療業界における顧客対応経験が活かせます。600 - 1200 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 同社は医療用医薬品やワクチンを研究・開発・製造・販売しています。
- 業務内容
- （1）担当する領域の製品、開発品に関する学術的な問い合わせ（電話およびMR経由の依頼）の二次対応（製品情報センターで回答できなかった場合の対応）…文献調査、文献選定、文献内容の要約もしくは関連部署からの情報収集により回答を準備し、電話または文書にて実施（2）問い合わせ対応データから顧客のニーズを判断し、提供用のQ＆A、製品情報センターの口頭回答用のQ&Aを作成、改訂（3）担当する領域の製品に関する顧客からの要望・提案、問い合わせにより生ずるリスクに対し、リスク最小化およびビジネス最大化のための対策を講じる（4）担当製品の関連情報の提供・収集を行い、医療現場における適正使用を確保（5）販売提携などのコ・プロモーション製品においては、提携会社と円滑に情報共有が実施できる体制を構築し、両社における情報提供の整合性を確保（6）グローバルMI担当領域製品チームの一員として下記業務を実施英語での科学的な回答文書（GSRD）の作成、レビューおよびGSRDの日本向けのローカライズを実施
海外からの英語での問い合わせに対応(文書回答)する。
（7）GPT（グローバル製品チーム）に参加し、日本のマーケット状況等を共有し、グローバルとしての最適なアクション立案に貢献※専門管理職は上記に加え、マネジメント業務について相応の役割を担っていただきます。
Martin Tsvetkov
Pharma -
求人番号：Job-00242270 掲載日：2023-03-18
Regulatory Coordinator
薬事部門にて申請書類に関わる何らかのご経験をお持ちの方必見です。600 - 1200 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 医薬品の研究開発・製造・販売を行っているグローバル企業です。
- 業務内容
- グローバルが提供するITツールなどを用いてpdf化をはじめとする電子申請サポートを行っていただきます。品質の高い申請資料の作成をサポートし、最も効率的なプロセス・方法を提案する。
規制当局提出文書（CTD、治験相談資料、CTN関連文書 等）のsubmission ready complianceを担保する。
全ての申請業務においてPMDAへの資料提出作業をリードする。
規制当局との会議（対面助言、初回面談等）に際し、Regulatory Strategy Leadと協力し、必要な文書作成をサポートする。
規制当局からの照会事項回答作成に際し、Regulatory Strategy Leadと協力し、回答文書の作成をサポートする。
グローバルチームと協力し、ドキュメントの作成・管理を行う。
egulatory ITと協力し、同社でのPublishing / Authoring tool導入、トレーニング及び業務プロセスの改善を行う。
業界活動等を通じ、提出文書や、文書提出方法の規制要件に関する最新情報を常に把握し、効率的なアイデアを提案する。
グローバルの担当者との円滑なコミュニケーションにより、提出文書の規制要件に関する最新情報や問題点・リスクをお互いに共有し合う。
外部ベンダー（eCTD vendor、印刷業者、翻訳業者等）との契約・折衝を担当し、最適なアウトソーシングを提案・実施する。
薬事関連文書の保管を行う。
治験薬概要書(和訳)作成に関して適切なプロセスを担保し、IB-Coordinatorをサポートする
Patrick Chang
Pharma -
求人番号：Job-00234735 掲載日：2023-03-18
【東京】MSL（未経験）
豊富なキャリアパス／研修・教育環境充実650 - 950 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 同社は、グローバルヘルスケアカンパニーです。
- 業務内容
- 国内トップクラスの規模とプロジェクト受託実績を誇る同社の一員となり、MSL（メデカル・サイエンス・リエゾン）としてクライアントビジネスおよび患者さんにとっての最適な治療法の確立に貢献していただきます。
MSLは、 担当する疾患領域における最新の科学知識に基づき、社外医科学専門家と同じ科学者同士の立場で医学的・科学的情報の交換並びに意見交換を通じて、アンメット・メディカル・ニーズ（注：未だ満たされていない医療ニーズ、有効な治療方法がない疾患に対する医療ニーズ）を収集し、育薬に貢献することが主な役割です。
具体的には、担当製品に関連する疾患・治療の国内外の最新情報を収集し、データの解釈や今後必要なデータ等について医療者と議論を行い、インサイト（知見）を得て、より安全な薬剤の使い方の検討や、より使いやすい薬剤への改善に活かします。
これにより、治療の効率が上がったり、適応症（対象となる疾病）が増えたり、次の新薬開発のヒントを得ることで、薬剤価値の最大化を実現させることが主な業務です。
そのほか、医療者からのリクエストに基づいた質疑対応や、臨床研究の相談窓口としての役割もあります。
Patrick Chang
Pharma -
求人番号：Job-00236403 掲載日：2023-03-18
MSL
世界的なリーディングカンパニーです650 - 950 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 同社は、グローバルヘルスケアカンパニーです。
- 業務内容
- 担当製品に関連する疾患・治療の国内外の最新情報を収集し、データの解釈や今後必要なデータ等について医療者と議論を行い、インサイト（知見）を得て、より安全な薬剤の使い方の検討や、より使いやすい薬剤への改善に活かします。
これにより、治療の効率が上がったり、適応症（対象となる疾病）が増えたり、次の新薬開発のヒントを得ることで、薬剤価値の最大化を実現させることが主な業務です。
そのほか、医療者からのリクエストに基づいた質疑対応や、臨床研究の相談窓口としての役割もあります。
Patrick Chang
Pharma -
求人番号：Job-00233822 掲載日：2023-03-18
MSL (Cardiovascular)
patient-centric company700 - 1100 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 世界的なヘルスケア企業です。
- 業務内容
- Medical Science Liaison (MSL) improves patients' lives by being the medical leaders through building and communicating the deepest medical knowledge and improving the medical benefits of our products.
MSL is dedicated to executing and supporting therapeutic strategies aiming to improve patient outcomes and quality of care consistent with overall medical ambitions and their policies.
The MSL functions actively to ensure building and maintaining strong scientific understanding of their marketed products and to support the development of portfolio products.
The MSL communicates up-to-date medical knowledge and clinical trial data with external stakeholders, and effectively respond to inaccurate competitive claims related to their products in a scientifically accurate and consistent manner aligned with the overall Medical Strategies and direction.
Leverages scientific and clinical expertise to create relationships with Key Opinion Leaders (KOLs) and Healthcare Professionals (HCPs). Identifies and develops strong and convincing speakers for our marketed products aligned with the Medical and Marketing Strategies.
Identifies, lists and communicates with KOLs and HCPs in the practice setting (e.g., academic centres, investigators, IISs research site) to update their understanding of relevant data in each context related to their products, as well as to build and maintain relationships to facilitate scientific exchange on topics of relevance to them.
Assists in identifying, engaging, and maintaining relations with KOLs and HCPs to establish and/or further the knowledge of their products and their appropriate use; when necessary, assist in resolving issues pertaining to that use. Assists in identifying and responding to inquiries from KOLs and HCPs; assisting with identifying those individuals with novel research concepts, clinical experience and expertise, within identified therapeutic areas of interest to them.
Gathers Medical insights regarding them and competitors’ products from KOLs and HCPs to help inform their decision-making bodies and update the Medical and/or Marketing Strategies if necessary.
Participates in assigned medical and scientific meetings to maintain awareness of current issues and new data pertaining to them and competitors’ products and to keep up medical booth in answering physicians’ scientific questions.
Identifies and develops strong and convincing speakers for our marketed products aligned with the Medical Strategy.
Support the on-boarding of new MSLs where required, clinical trials by driving scientific discussion at site selection and site initiation visits where required and scientific dialogue with investigators at prioritized/requested sites and patient recruitment and retention of subjects where required.
Assists regional Medical Representatives (MRs) in handling scientific and clinical questions for their marketed products from KOLs and HCPs.
Participates in a series of internal medical/scientific trainings and regular scientific assessments to maintain general scientific knowledge and awareness of new data pertaining to them and competitors’ products.
Complies with all guidelines, policies, legal, regulatory, and compliance requirements.
Emely Motol
Pharma -
求人番号：Job-00227878 掲載日：2023-03-18
【品川】CDxの日本開発リード（コンパニオン診断薬の申請活動）
2022年度新設ポジション！700 - 1000 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 同社は、大手製薬会社です。
- 業務内容
- ■職務概要：日本におけるCompanion Diagnostics（以下、CDx）承認申請活動の増加に対応いただきます（日本における医師主導治験結果に基づいた申請を含む）。そして、2022年度から新設されたCDx日本開発リードの役割を確固たるものにしていただきたいと考えております。
■職務内容：◇各品目のグローバルCDx開発戦略に沿って、日本の診断薬パートナーおよび社内関係者（グローバルCDxリードおよび社内プロジェクトチームメンバーなど主要関係者）と日本のCDx申請に向けた戦略や業務計画を作成および実行するとともに、日本独自の要件に応じて適宜対応する
◇必要に応じてPMDA会議に参加し、日本の診断薬パートナーのCDx申請を支援する
■キャリアパス：日本CDxリード、チームリーダーを目指していただけます。
Patrick Chang
Pharma -
求人番号：Job-00211301 掲載日：2023-03-18
[Tokyo] Medical Science Liaison in Diabetes
Rich Pipeline and Expanding500 - 1200 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 世界的なヘルスケア企業です。
- 業務内容
- Identifies, lists and communicates with KOLs and HCPs in the practice setting (e.g., academic centres, investigators, IISs research site) to update their understanding of relevant data in each context related to products, as well as to build and maintain relationships to facilitate scientific exchange on topics of relevance to company.
Assists in identifying, engaging, and maintaining relations with KOLs and HCPs to establish and/or further the knowledge of products and their appropriate use; when necessary, assist in resolving issues pertaining to that use.
Assists in identifying and responding to inquiries from KOLs and HCPs; assisting with identifying those individuals with novel research concepts, clinical experience and expertise, within identified therapeutic areas of interest.
Gathers Medical insights regarding company and competitors’ products from KOLs and HCPs to help inform company decision-making bodies and update the Medical and/or Marketing Strategies if necessary.
Participates in assigned medical and scientific meetings to maintain awareness of current issues and new data pertaining to company and competitors’ products and to support medical booth in answering physicians’ scientific questions.
Identifies and develops strong and convincing speakers for our marketed products aligned with the Medical Strategy.
Assists regional Medical Representatives (MRs) in handling scientific and clinical questions for company marketed products from KOLs and HCPs.
Support the on boarding of new MSLs where required.
Support clinical trials by driving scientific discussion at site selection and site initiation visits where required.
Support scientific dialogue with investigators at prioritized/requested sites and patient recruitment and retention of subjects where required.
Participates in a series of internal medical/scientific trainings and regular scientific assessments to maintain general scientific knowledge and awareness of new data pertaining to company and competitors’ products.
Complies with all guidelines, policies, legal, regulatory, and compliance requirements.
Patrick Chang
Pharma -
求人番号：Job-00228391 掲載日：2023-03-16
Epidemiologist
Leading Diabetes company700 - 1500 万円 関西 製薬 メディカルアフェアーズ
- 会社概要
- 同社はグローバル規模の医薬品・臨床研究の企業です。
- 業務内容
- 1. Safety Observational studyのScientific LeadPlan and execute research and research on drug epidemiology for research questions on drug safety (protocol creation, analysis plan creation, survey implementation using databases including medical information database and medical information, test report) , Writing a paper, etc.).
2. Contribution to the creation of a drug risk management planAs an expert in drug epidemiology, contribute to the development of drug risk management plans.
3. Demonstrate epidemiology expertiseDemonstrate epidemiology-related expertise from a safety perspective and support activities throughout the product life cycle from drug development to post-manufacturing and marketing (preparation of responses to inquiries from regulatory authorities, plans to create RWD / RWE) Formulation / execution, investigation to deepen understanding of disease pathology, etc.)
4. Collaboration with related departments within the company and collaboration with external customersCollaborate with internal related departments (development team, Safety, Medical Affairs, Regulatory, etc.), external experts, CROs, etc. to support activities from the perspective of safety-related drug epidemiology.
5. Activities related to PharmacovigilanceUnderstand the regulations and rules related to Japanese pharmacovigilance. Creates and maintains a Safety Quality System (safety-related SOP) related to drug epidemiology, and provides related training.
6. Utilization of analysis toolsUtilize various data (medical information database, medical information, etc.) and analysis tools for research and research on drug epidemiology, and contribute to the provision of high-quality outcomes.
Emely Motol
Pharma -
求人番号：Job-00241240 掲載日：2023-03-16
Principal Scientist (Neuroscience/pain)
rich pipeline1000 - 1500 万円 関西 製薬 メディカルアフェアーズ
- 会社概要
- 同社はグローバル規模の医薬品・臨床研究の企業です。
- 業務内容
- Neuroscience/Pain領域において、医学、科学的な専門性にもとづいて、担当薬剤のさまざまな研究開発と市販後メディカルアフェアーズ業務をリードする。
同領域の臨床開発、すなわち臨床試験の計画・プロトコール作成、および試験遂行・承認申請・論文公表を医学専門家としてリード
同領域におけるメディカルアフェアーズ活動を医学専門家としてリード
外部顧客（医学専門家、治験協力医師など）との良好なパートナーシップを維持
Emely Motol
Pharma -
求人番号：Job-00243489 掲載日：2023-03-15
【東京】MSL：ワクチン領域
ワクチン領域の経験をお持ちの方必見です。550 - 650 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 同社は、製薬・医療機器企業、その他ヘルスケア企業向けに様々なサービスを提供しています。
- 業務内容
- 主にKOL（キーオピニオンリーダー）のマネジメントや臨床研究支援になりますが、具体的には以下です。学術トピックスの提供、新薬の情報提供。
医師主導研究への対応
地区スピーカー育成
適用外使用等の情報提供
Patrick Chang
Pharma -
求人番号：Job-00233835 掲載日：2023-03-14
Veterinary Affairs
獣医師の方必見です1000 - 1500 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 同社はペットフードの開発・製造・販売等を行っています。
- 業務内容
- The position will lead a team of 4 Professional Consulting Veterinarians (PCV).As a manager, he/she supervises and supports team members to fully implementtheir responsibility. And also he/she manages and coaches members so that they can achieve their highest performance.The position will also be responsible as a PCV of an assigned territory.He/she is the primary ‘on--the--ground’ Professional Veterinary Affairs (PVA( resource to support our Customer Development (CDO) and responsible for relationship building, education and influence of veterinary customers that results in endorsement and active recommendation.This position is critical to ensure that our company is positioned as an important scientific, innovative and credible partner who is engaged in improving the health of dogs and cats and in supporting the profession.This position serves as the technical liaison for the district; consulting, coaching and training Veterinary channel resources on the ground.
Principal Duties and Responsibilities Task
30%PCV team management
Support PVA associate director to set PCV strategy and KPIs
Track KPIs and coach PCV(s) to improve their performance
Build strong one team culture and drive motivation of PCV(s)
Support team to collaboration with CDO at each districts
50%The primary ‘on--the--ground’ PVA resource to support our Customer Development (CDO) :
Technical education for Vets and Vet nurses, collaborating with other PVA team
Visiting strategic accounts with CDO
Technical coaching for CDO field team
10%Engagement with influencers:
Execute engagement plan with in practice specialists and KTLs
Oversees agreed trial / testimonial execution with them
Nurture academic KTL relationships in assigned area
5%Engagement with priority vet schools in assigned area
5%Professional engagement
Attend selected conferences, including specialty ones, and work our exhibit booth, building relationships
Execute local events ( roadshows etc )
Shotaro Tsubaki
Medical Device -
求人番号：Job-00210945 掲載日：2023-03-07
R&D Japan/ Group Manager, Innovation Management Office
Alliance / Open Innovation800 - 1600 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 同社はグローバル製薬会社です。
- 業務内容
- All R&D communication physically such as THM and/or virtually such as via e-mail/R&D Portal site etc. R&D regular leadership communication such as RD SLT and LT.
Any R&D responsible technology-based innovation initiatives such as Robotic Process Automation, Cloud based cross functional team communication, as well as center of excellence to shard service provider at R&D. In addition to that the Group will provide service to lead non-R&D specific career development program to whole R&D, as well as to be responsible for new grads program execution.
Patrick Chang
Pharma -
求人番号：Job-00230230 掲載日：2023-03-07
Ass. Director/Sr. Director Medical Affairs
Growing pharma company1200 - 2700 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 希少疾患に特化したグローバルカンパニーです。
- 業務内容
- Responsibilities will include, but are not necessarily limited to, the following:Hands-on and on-the-ground experience of strategic and tactical planning and day-to-day execution of typical medical affair’s duties is mandatory.
People management: When assigned, manage limited number of JMA staffs, including Filed Medical (Medical Science Liaison) Team and/or operation assistant of JMA. Act as a single point of contact of the designated team(s), tasks and projects in Global Medical Affairs (GMA). Work as a representative of JMA in local/global committees, including Japan Leadership Meeting. Ensure responsible activities are planned and executed in compliance with applicable global/local laws and regulations, and company policies, SOPs, Work Instructions (WIs) and requirements.
A candidate with a degree in medicine (physician): Act as a medical expert to provided medical guidance and support for activities by JMA and GMA, clinical development and activities including, but not limited to, drug safety and pharmacovigilance.
Strategy and operation: Manage strategy and tactics building, planning and execution of JMA plan (JMAP) for designated tasks and projects, in alignment with those of GMA and other internal stakeholders of the local country and global functions as well as governance committees.
Medical/Clinical/Scientific expertise: Have in-depth understanding (medical, scientific, business) of designated products and technologies. Provide key medical/scientific inputs to internal stakeholders and functions locally and globally.
Expert Engagement and Scientific Exchange: Manage and coordinate engagement with external stakeholders (e.g., Scientific Leader (SLs), HCPs, congress, medical and academic societies) with medical/scientific integrity. Ensure compliant and productive bi-directional day-to-day communications (i.e., scientific exchange).
Congress: Attend key domestic and international academic congresses for medical/scientific competitive intelligence. Lead on-site scientific engagement with external experts. Oversee reporting processes.
Scientific and operational excellence: Work as a functional-area leader and champion to develop and maintain/upgrade excellence in both science and operations.
A candidate may be assigned specifically to one or more of the following duties and/or as a manager of a certain product(s):
Advisory Board: Manage and coordinate strategy building, planning and execution of designated local medical and scientific advisory board through cross-functional (local and global) collaboration, external advisors and 3rd party stakeholders and vendors.
Medical Education (key activity of this role): Manage the development and implementation of medical/scientific education strategy and action plans targeting HCPs and patients in Japan. Work collaboratively with SLs, internal functions (Japan and global particularly with Medical Directors in GMA as well as external stakeholders and 3rd party vendors to execute action plans with uncompromised compliance standard and medical/scientific integrity. The work involves creation and distribution of education materials and information package using both conventional and digital medias as well as planning and execution of company sponsored speaker program targeting HCPs and patients in Japan.
Evidence Generation (key activity of this role): Take a cross-functional, project-level leadership for designated Japan local data generation project(s). It includes but is not limited to the identification of data gap and need in Japan, planning and execution of post-launch company-sponsored study (CSS) in Japan (e.g., robust analysis, effective dissemination including but not limited to the development of study concept, selection, oversight and management of CRO and 3rd party vendors, feasibility assessment, development or review of protocol / CRF / IC / SAP / CSR, management and collaboration with a steering committee and the management of study timeline and budget), as well as support for an assigned Investigator-Initiated Research (IIR) (e.g., communication with investigators and internal stakeholders and committees, execute relevant legal agreement in collaboration with Legal & Compliance and grant payments, monitor and track timeline including IRB approval / FPI / LPLV / CSR /publication and study closing) and Independent Medical Education (IME) grant programs. Ensure all activities are conducted in compliance with applicable laws (e.g., Clinical Study Act), regulations (e.g., GCP), guidelines (e.g., Ethical Guidelines for life science/ medical and health research involving human subjects) and company policies, SOPs, WIs and requirements. Health Economics and Outcome Research (HEOR): Manage medical and scientific inputs from JMA to market access and NHI pricing activities for designated products by partnering with internal stakeholders, including but not limited to the Market Access & Pricing and Cost Effectiveness Analysis (CEA), Legal & Compliance, JMA teams in company and HEOR team in GMA.
Publication: Provide oversights and support for the development and implementation of Japan local publication plan (Local Publication Plan: LPP) for congress presentations and manuscript publications in alignment with global publication objectives. Ensure designated activities are executed in adherence to policies, SOPs, and consistent with relevant external scientific standards (e.g., GPP3, ICMJE guidance).
Governance: Manage, coordinate and/or be involved in the review and decision process in Japan and global governance committees (e.g., Medical Review Committee (MRC), Commercial Review Committee (CRC), Grant Review Committee (GRC), Medical Affairs Research Review Committee (IMARRC), other global committees).
Clinical Development: Support strategy/plan building for clinical development and its execution in Japan, including medical/scientific interactions with local authorities such as PMDA and MHLW, by providing medical and scientific inputs as appropriate. Support Clinical Operation Team for their assessment and selection of trail sites and investigators as needed. Support the identification and selection of external medical expert as needed.
Japan business: Collaboratively work with internal functions across R&D and commercial areas as well as external stakeholders to support local business in Japan, including but not limited to initiative relating to market access and pricing. If selected, function as one of the core senior members of Japan Leadership Meeting (JML) to lead and/or facilitate information sharing and decision making. Act as a leading liaison between JMA and Commercial functions.
Emely Motol
Pharma -
求人番号：Job-00226602 掲載日：2023-03-06
【カジュアル面談】【CRA／MR／学術経験者歓迎】未経験MSL<メーカー転籍実績あり>
理系大学院もしくは薬剤師資格をお持ちの方でCRA経験をお持ちの方必見です。500 - 650 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 同社は、製薬・医療機器企業、その他ヘルスケア企業向けに様々なサービスを提供しています。
- 業務内容
- 学術トピックスの提供、新薬の情報提供。
医師主導研究への対応
地区スピーカー育成
適用外使用等の情報提供
Martin Tsvetkov
Pharma -
求人番号：Job-00222832 掲載日：2023-03-03
Medical Advisor/MSL
MSL800 - 1600 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- グローバルメディカルカンパニーです。
- 業務内容
- Scientific Leadership:
Communicate scientific therapy needs credibly, appropriately, and effectively across a variety of internal and external stakeholders at all levels.
Build trust with the external scientific community via peer-to-peer scientific exchange, research and educational collaborations, interactions with scientific societies and health organizations, publications, etc.
Provide therapeutic/functional training to assigned teams and affiliate functions.
Develop and help execute country medical educational programs and symposia.
Lead country Advisory Boards and Expert Input Forums in line with strategy.
Participate in and contribute significantly to professional organizations, academic or regulatory working teams.
Lead executes country medical educational programs and symposia.
Medical Strategy and Therapy Leadership:
Translate Global Medical Strategies into research, data analysis, scientific communication, educational, and other tactics and solutions that improve patient outcomes and enhance access in the country.
Ensure effective communication and collaboration between field and Medical through providing scientific and medical support to the Commercial team.
Evaluate accuracy of promotional materials.
Provide Medical Affairs therapeutic area support through engaging with SLs/KDMs, driving scientific initiatives and supporting the field force.
Collect, analyze, and communicate actionable insights at the country level.
Provide scientific inputs for digital initiatives.
Successfully collaborate, provide scientific inputs, and lead resolution of Regulatory queries/issues.
Support execution of and quickly adapt tactical plans to business realities in country.
Act with ethics and integrity; Provide non-promotional, balanced, reliable and scientific information.
Support with therapy training content for Sales team.
Demonstrate strategic thinking, specifically related to asset value proposition, and clinical and value evidence.
Support creation of Medical Affairs Plans along with the TA and Country Medical Leads.
Martin Tsvetkov
Pharma -
求人番号：Job-00233823 掲載日：2023-03-03
MSL Manager (Diabetes)
patient-centric company1000 - 1200 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 世界的なヘルスケア企業です。
- 業務内容
- Ensure personal and professional development of the MSL team; and ensure coordination and cooperation between the MSL team, the MSL Supervising Group Manager (SVM), and other relevant stakeholders.
Represents the MSL team internally within the affiliate and in external scientific events, creating business opportunities for the MSL function.
Initiate, foster and maintain cross-functional communications and collaboration, ensuring the proper understanding of the MSL roles and responsibilities by cross-functional departments.
Accountable for ensuring that the MSLs act in full compliance with all laws, regulations, Business Ethics standards and internal policies (SOPs).
Lead the MSL efforts to identify and support Key Opinion Leaders (KOLs) in cooperation with relevant stakeholders and consistent with overall Medical Strategies and direction.
Provides medical insights from KOLs/HCPs gathered by MSL and reports to SVM so that he/she can aggregate, analyse and report them to the senior management team and key internal stakeholders.
Reviews, evaluates, and channels information to the appropriate personnel, if needed, and provides timely responses to requests from the MSLs for support of various activities in their respective regions.
Acts, and is accountable for others in his/her team acting, in complete and total compliance with all laws, regulations and policies; gives MSLs advice regarding compliance reporting. Ensure MSLs respond to on- and off-label questions from HCPs with highest integrity, compliance, and adherence to legal, regulatory and company guidelines, policies and procedures.
Provides mentoring and builds the talents of MSL particularly with respect to knowledge of technical and scientific information, business practices, and communication and motivational skills.
Spends adequate field time with direct reports to coach and develop personnel and ensure that unit objectives are being met.
Assists direct reports in setting/reviewing annual goals and coaching them on IDPs.
Prepares with MSLs for field medical events which are supposed to be initiated by the team: reviewing agendas and decks.
Actively manages the field medical team by putting the right people on the right projects, based on their capacity/skill/interest/capability.
Communicates their policies, procedures, organizational changes to direct reports and answers team’s questions.
In collaboration with Sr. MSL, evaluates field performance of MSLs on site and gives timely and constructive feedback and guidance to them.
Assist SVM in planning, executing internal scientific trainings, business meetings etc. for MSLs.
Takes a leadership role in coordinating activities at assigned medical and scientific meetings and symposia.
Supports MSLs to appropriately coordinate presentation with speakers and ensure the presentation is well aligned with their strategy.
Takes a leadership role in coordinating and resourcing activities, including allocating people resources, speaker training, sales support, and supporting appropriate use of their products.
Ensures that direct reports understand the priorities of the business, that their work is focused on those priorities, and that they understand their level of accountability for results and the measurement process.
Emely Motol
Pharma -
求人番号：Job-00230939 掲載日：2023-03-03
Senior Epidemiologist
Global company800 - 1400 万円 東京 製薬 メディカルアフェアーズ
- 会社概要
- 同社は、ヨーロッパに本社を置く国際的な薬事関係企業です。
- 業務内容
- Collaborating with key stakeholders in Medical Affairs and Pharmacovigilance and related functions including global, the Integrated Evidence Generation (IEG) Epidemiologist takes following tasks and responsibilities:
Lead the development and execution of sponsored RWD/RWE studies based on expertise in epidemiology and research methodology inpartnership with Therapeutic Area Medical Affairs (MATA) and post-marketing surveillance (PMS); the IEG Epidemiologist mainly covers PMS projects - Primary RWD/RWE (e.g., Non-interventional study) - Secondary RWD/RWE (e.g., Database study including PMS) - Patient-generated health data including patient reported outcome and digital biomarkers
Develop the concept and protocol of primary and secondary RWD/RWE studies Review the concept and protocol of primary and secondary RWD/RWE in collaboration with MATA Support RWD/RWE generation led by Market Access (e.g., HEOR study) and by RDJ as a collaborator
Provide epidemiological inputs for clinical and post-marketing studies, aggregated reports, responses to regulatory queries, etc.
Contribute to developing the design and plan of risk-management initiatives and PMS
Contribute to the preparation of local processes and contract related to RWD/RWE concerning the regulatory requirement and guidance related toRWD/RWE
Perform RWD analysis to provide the valued insights to support drug development and post-marketing risk management
Assess databases (e.g., clinical registry, healthcare database) used for sponsored observational studies and PMS and ensure that the data quality and handling process are in compliant with regulatory guidance/requirement
Obtain the up-to-date information and new technologies/methodologies related to RWD/RWE and feed back to internal stakeholders Define and lead the value creation by technologies/methodologies in the field of RWD/RWE to address the issues/opportunities for furtherstrengthening RWD/RWE capability.
Provide trainings in RWD/RWE related field for internal and external stakeholders upon needs based on his/her profound professional knowledge
Emely Motol
Pharma -
求人番号：Job-00236420 掲載日：2023-03-03
Associate Manager/Scientific Expert
global position1000 - 1500 万円 関西 製薬 メディカルアフェアーズ
- 会社概要
- 同社は、ヨーロッパに本社を置く国際的な薬事関係企業です。
- 業務内容
- Act as member of the multidisciplinary brand team
Help guide the strategic direction in therapeutic areas
Distill clear content from the wealth of scientific data
Help create convincing communication concepts in cooperation with marketing and external partners
Contribute to the content of promotional materials
Approve promotional materials
Develop good relationships with key opinion leaders
Answer medical questions concerning products Train sales force reps regarding medical aspects
Leading scientific advisory boards
Contribute to a flow of relevant publications
Create a review of relevant publications
Contribute to a digital strategy
Help marketing and sales force drive the business
Emely Motol
Pharma