外資系大手製薬メーカー　Medical Advisor

資格・要件

Formal Education And/or Experience Required:
Advanced degree (MD, PharmD, PhD in life science or equivalence)
Knowledge of ICH, GCP and local regulations
Fluent in English
Knowledge And Skills Desirable but Not Essential:
MD degree is preferred
Qualification in a medical specialization would be preferred but not required
Previous experience in Clinical Practice, Clinical Research and/or Drug Development is a plus

職務内容

Medical Advisors provide medical and scientific expertise and guidance to investigators and CSU (Clinical Study Unit staff performing clinical trials within a CSU cluster to ensure patient safety and scientific integrity of the protocol which ensures the reliability of information provided to agencies at submission. They are therapeutically aligned medical experts in the country/region for the studies/projects they are responsible for. They provide appropriate medical and scientific feedback to Local CSU operations teams as well as global R&D Medical Operations, i.e., Clinical Research Director (CRD), Global Feasibility Lead (GFL), TA early planning leads, global project team, pharmacovigilance, and regulatory affairs. They ensure the medical and scientific collaboration with medical functions in the respective Business Units in the countries of their responsibility and with investigators, trialists, medical experts, and Key Opinion Leaders (KOLs) in the country, region, or global level.

Responsibilities

Provide medical/scientific value across a continuum of both external and internal stakeholders: e.g., Key external experts and other healthcare professionals within assigned therapy area or assigned programs, (potential) investigators, professional societies, and patient organizations.

Review and resolve local medical issues / questions that arise during the entire course of the study and that arise from local regulatory authorities – if necessary, transferring issues to global teams.

Proactively seek and collect the medical voice of the external experts, potential investigators and KOLs to facilitate the conduct of clinical trials. Through appropriate scientific exchange and scientific engagement with external stakeholders, secure advice that informs and assists internal strategic functions in the development of compounds.

Act as the local medical expert to bring early input into study design and operational aspects.

Provides timely medical training to local Monitoring Team, including training to CSU staff on protocols, therapeutic area, disease, products, medical environment, medical and/or scientific training to new hires.

Provides medical and scientific advises to key internal stakeholders developing proposals: this may include, but is not limited to, reviewing the protocol for scientific/regulatory soundness and feasibility, providing medical/scientific insights on target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.

Exchange information between R&D and other departments within the affiliate and contribute to Medical Department Team meetings related to the therapeutic area to ensure objectives of these meetings are met.

Local scientific knowledge and lobbying allowing capture of country specific information on competitive intelligence and validation of global hypothesis from the Clinical Development Plan or assessment of Extended Synopsis (ES)/protocol contents.

Liaise with local Medical Leads within Sanofi Global Business Units in his /her country(ies) to manage investigators and compounds.

Support local/regional Investigator Meetings regarding medical content and interaction with investigators in collaboration with CRD.

Ensure accuracy of translation of medical terms related to study documents when translated into the local language, including ICF, patient materials, wherever appropriate.

Contribution to protocol optimization and standard of care assessment as a part of Pressure Test to position the study in the ecosystem and drive local strategy.

Patient Network Engagement at local / regional level, being the link to Patient Informed Development & Health Value Translation Team.

Collaborate with TA Lead providing impactful and relevant local information to support the Global Strategy per TA including information to support diverse study population.
【その他情報】
契約期間：期間の定めなし
試用期間：3か月
就業時間：8:45～17:30
休憩時間：60分
フレキシブルタイム：あり
時間外労働：あり
休日休暇：
完全週休2日制（休日は土日祝日）
年間有給休暇　初年度11日
年間休日日数125日
【将来的に従事する可能性のある職務内容】会社の定める職務
＜将来的に勤務する可能性のある場所＞会社の定める事業拠点（テレワークを行う場所を含む）
＜休日・休暇＞
■慶弔休暇　■有給休暇　■産前・産後休暇　■育児休暇
■母性保護休暇　■妊婦健診休暇　■5月1日
■フレキシブル休暇2日
■ラ・メゾン休暇（「未使用で無効になってしまう有給休暇を活用する」ための制度）など
受動喫煙対策：あり　就業場所　全面禁煙
加入保険：雇用・労災・健康・厚生年金保険
在宅勤務制度：有