Jobs list of Medical Device
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Job number: Job-00240518 Posted: 2023-10-17
Clinical Traning Specialist
元看護師・臨床工学技士の方優遇案件です7 - 9 million yen Tokyo Medical Device Training / Education
- Company overview
- Our client is one of the biggest Medical device company.
- Responsibilities
- Develop and execute physician training programs and events. Provides expertise and clinical insights on the device, procedure and protocol throughout the life cycle of the clinical case.
Key Responsibilities
Develop external training curriculum and manage all activities.
Partner with Global Business Unit to develop material content and communications for distribution to clinical sites, including Japanese translation of technical terminology.
Document procedural case observations for insights in investigating post procedural events.
Develop and continuously improve training materials, training tools, and curriculum, based on clinical trial experience.
Other incidental duties
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Job number: Job-00217837 Posted: 2023-12-29
RA Manager
People Management経験不問です!7 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- One of the largest electronics company with products in various business, including Healthcare and Consumer Products.
- Responsibilities
- 製造販売承認/認証申請、届出(計画立案、資料取集、PMDA/NB 照会対応)
承認/認証の維持管理業務(変更管理、定期更新)
QMS適合性調査申請
保険収載業務(保険適用希望書作成等)
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Job number: Job-00223148 Posted: 2023-06-15
Clinical Specialist
メーカー未経験の放射線技師の方必見です7 - 11 million yen Tokyo Medical Device Clinical Specialist
- Company overview
- Our client is one of the biggest Medical device company.
- Responsibilities
- 新規治療デバイスに関し、医師およびコメディカルに対し製品の取扱い説明
適正使用のための説明会・トレーニング等の運営
社内関係部署に対してのトレーニング実施
トレーニング資料・学会レポート作成
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Job number: Job-00242344 Posted: 2024-04-15
Regulatory Affairs Specialist | 薬事スペシャリスト
Global pioneer in healthcare seeks seasoned RA specialist7 - 10 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- Our client is one of the world\'s largest medical device manufacturers, operating as a global enterprise with over 40,000 employees worldwide. It provides innovative, non-invasive medical devices to its clients and plays a vital role in advancing medical practices by enhancing patient health, making a significant impact on the healthcare industry.
- Responsibilities
- Main responsibilities:
Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation.
Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation.
Provide management team with regular updates on product registration and new regulations from government body.
Provides input on regulatory- related issues associated with compliance and achieving the business plans. Prioritize and plan on product registration for his/her respective product lines.
Preparing, coordinating and submitting regulatory applications to the local health authority.
Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.
Provide the management team with regular updates on product registration.
Ensure product registrations are reviewed and renewed as required.
Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.
Lobby the local health authorities using constructive/scientific challenges to regulations.
This should include guidance on alternative solutions to country regulatory needs.
Supports tender operations by timely supply of accurate regulatory documents.
Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.
Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
Serves as regulatory consultant to marketing team and government regulatory agencies.
Complete the mandatory Quality training subject to the defined timeline.
Ensure compliance with internal Quality system and policy.
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Job number: Job-00249367 Posted: 2024-01-11
Biochem Analysis Equipment Product Manager
World\'s leading pharmaceutical maker7 - 8.5 million yen Tokyo Medical Device Marketing
- Company overview
- Our client is a prominent biotech company that specializes in the development of innovative solutions for disease diagnosis. They provide a range of products for various diseases such as cancer, cardiovascular, and infectious diseases.
- Responsibilities
- 製品のライフサイクルマネジメント(グローバル製品の日本への導入・発売から安定供給、終売までのプロダクトケア)
マーケティング・販促活動(マーケティング戦略の策定、関連製薬企業との共同プロモーション、販促資材の作成、学会展示やセミナー開催、メルマガ配信など)
顧客からの問い合わせサポート(一次対応部署からの問い合わせへのサポート)
グローバル組織とコミュニケーションを図り、製品ライフサイクルマネジメント業務を遂行する
社内の営業組織、アプリケーション担当者に対し、効果的な販促戦略を展開する
医師、検査技師に対するヒアリングを行い、製品開発、マーケティング戦略に反映させる
関連する他企業と協力し、効果的なプロモーション活動を市場へ展開する
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NEWJob number: Job-00242914 Posted: 2024-04-22
Start up specialist
大手医療機器メーカー x 新型ロボット製品7 - 10 million yen Tokyo Medical Device Clinical Specialist
- Company overview
- Our client is a world leading medical device manufacturer.
- Responsibilities
- Main Mission of Job:
大型医療機器を全国の病院様に展開していきます
展開した大型機器を安全に導入し運用のサポートを行っていただきます
大型機器を通じて手術プログラムの計画・展開、同社の関連製品を含む機器の手術室内での準備及び洗浄・滅菌など、それらを可能とするために顧客への適切なアドバイスとトレーニングを実行します
これらの活動は各医療機関ごとに4か月~8か月ほど継続して行われ、安全な機器使用に導くことをゴールとします
“A Day in the Life”:
ご施設責任者と面会し、同社の大型機器の使用目的及び目標を共に設定します
フィールドサービスエンジニアおよび病院スタッフと協力して、同社の大型機器の運用準備を手術室で行います
必要な器具の洗浄および滅菌するように病院スタッフをトレーニングします
外科医のトレーニング計画を作成しオフサイトトレーニングをスケジュールしサポートします
サポートスタッフのトレーニング計画を作成しオフサイトトレーニングをスケジュールしサポートします
主となる外科責任者との定期的なプログラムレビュー会議を実施します
大型機器習得の経験曲線中のほとんどの手術に立ち会うことによってサポートを行い自律的に運用できるよう顧客と共に目標を設定しマネジメントを行います
病院様が自立して大型機器運用が可能となったら、次のお客様のサポートを開始します
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Job number: Job-00243151 Posted: 2024-04-11
Quality Engineering Manager
Gaishi to set up new production in Japan7 - 10 million yen Tokyo Medical Device Product Engineering
- Company overview
- Our client is a clinical-stage biotechnology company.
- Responsibilities
- Contribute to cross-functional project(s) as engineering expert.
Communicate with external manufactures to improve / develop the medical devices.
Build strong relationship with external partners.
Compliance with Quality Policy and regulations
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Job number: Job-00256030 Posted: 2024-03-21
Quality Assurance - Eye Care Products | アイケア関連製品における品質保証
日系安定成長企業・顧客満足度を向上させる重要な役割を担っていただきます7 - 12 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- Our client is a Japanese optical equipment manufacturer.
- Responsibilities
- 当社アイケア製品の品質保証に関する業務全般をお任せします。
業務内容:
苦情内容に関する調査・分析
苦情情報の調査・分析に関する品質改善指示
苦情の是正と予防対応
出荷停止及び解除に関する業務
回収/改修に関する業務
製造販売後の法規制に関する業務
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Job number: Job-00256537 Posted: 2024-01-11
Application Specialist | アプリケーションスペシャリスト
感染症のエキスパート・製造元である本社とメールや会議などのやり取りが多く発生する業務7 - 9.3 million yen Tokyo Medical Device Clinical Specialist
- Company overview
- Our client is a multinational biotechnology company that designs, develops, and produces a wide range of diagnosis systems to hospitals and industrial companies.
- Responsibilities
- 業務内容:
弊社製品、微生物検査関連の最新技術情報(ソフトウェアや新しいITソリューションなど)を製造元の本社などから入手し、ビジネスプランを策定
関連部門(MKTG、SALES、MA)からの依頼に応じて資料を作成し、必要に応じて資料内容の社内トレーニングを実施
市場において当社ソフトウェアおよびサービスのバージョンが常に最新バージョンに維持されるよう、社内リソースを最適化
顧客先においてサードパーティITベンダーの担当者、医療機関IT担当者と協業し、当社システムと医療機関システムの接続環境 の技術仕様について協議し、システム接続を推進
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Job number: Job-00254567 Posted: 2023-09-05
Regulatory Affairs Senior Specialist | 薬事シニアスペシャリスト
Class IV RAにご興味ある方が対象です7 - 9 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- Our client is a renowned global healthcare corporation specializing in the development, manufacturing, and distribution of a diverse portfolio of medical devices, pharmaceuticals, and consumer products.
- Responsibilities
- 日本国内で心臓アブレーション治療や脳血管治療関連の製品を展開しています。その薬事担当としてクラスIV機器の新製品導入・適応拡大といったチャレンジングな薬事申請及び既存製品の維持活動を主たる業務とするポジションです。
業務内容:
海外製造元、ビジネス部門、臨床部門、品質管理部門等と協業
PMDA、MHLWとの交渉を成功に導くことで、承認取得から保険適用、製品発売、市販後の社内外のプロセスを完遂していただきます。
CSS RA Headにレポートします
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Job number: Job-00256162 Posted: 2024-01-18
Software Developer | ソフトウェア開発
上流工程でのご経験が活かせる・福利厚生が充実している企業7 - 12 million yen Tokyo Medical Device Product Engineering
- Company overview
- Our client is a medical device manufacturer.
- Responsibilities
- 業務内容 :
ナビゲーションシステム開発心臓カテーテル治療における医師のガイドワイヤ操作、ルート検討をソフトウェアにより支援する製品の開発業務
ソフトウェア開発体制の構築自社開発を見据えたソフトウェア人材の育成
製品開発において必要となるインフラやソフトウェアリリース後にフィードバックとして取得するデータの管理基盤構築
システムの要求仕様をまとめ、仕様設計からソフトウェア評価までの一連の製品開発プロセスにおける全体あるいは一部について、社内及び協力会社を率いて遂行いただきます。
要求仕様の分析(顧客からの要求を分析し、システム全体・エンドユーザへの影響を検討し、仕様を立案)
基本設計(要件定義で決定した内容に基づき、システムの全体像を設計)
量産ソフトウェア開発(要求仕様に基づき、可変性、可読性の高いソフトウェアを社内および協力会社と構築し評価)
※国内外の転勤可能性あり(当面なし)
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NEWJob number: Job-00254508 Posted: 2024-04-25
Business / Market Intelligence | BI・市場調査
Drive business results with data-based insights7 - 10 million yen Tokyo Medical Device Commercial Excellence / Sales Operations / SFE
- Company overview
- Our client is a renowned global healthcare corporation specializing in the development, manufacturing, and distribution of a diverse portfolio of medical devices, pharmaceuticals, and consumer products.
- Responsibilities
- Mission:
The Market Intelligence Team's role is to facilitate business growth by supplying impartial market data for informed decision-making. Main responsibilities:
Develop and update market intelligence model to provide market relevant data and insight to business leaders at each financial cycle
Connect primary/secondary data (external sources) with internal data and continuously verify them to propose highly accurate market trends and competitive advantages
Be a hub of market information (procedure, product, competitors, and customers) in the company by engaging stakeholders and integrating relevant information.
Collaborate with business units and research firms to plan and conduct market research as a means of solving business issues.
Provide market information insights to business leaders to generate competitive advantages for the company.
Lead cross functional teams and influence key stakeholders in delivering results
Understand market and business dynamics and develop/adapt strategies to drive growth through market expansion, penetration, and market share gains.
Actively and skillfully conceptualize, apply, analyze, synthesize, and/or evaluate information gathered from, or generated by, observation, experience, reflection, reasoning, or communication, as a guide to belief and action
Manage successfully in a matrix organization, drive cross-functional team engagement, and create and sustain internal relationships with franchises and functional teams
Be a source of strategic insight and direction in the Business Unit and the Franchise. Inspire the teams to fulfill customer requirements and fuel business growth
Obtain broad knowledge and understanding of the technical, operational, commercial, and marketing elements of the business and the organization. Make good judgments and quick decisions based on robust business understanding.
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Job number: Job-00254618 Posted: 2024-04-16
【東京】営業戦略・企画 (THV)
営業企画経験者必見です!7 - 12 million yen Tokyo Medical Device Commercial Excellence / Sales Operations / SFE
- Company overview
- Our client is one of the biggest Medical device company.
- Responsibilities
- 経カテーテル大動脈弁治療を促進するために、営業組織のパートナー/コンサルタントとして従事する
SFE(Sales Force Effectiveness)により、ビジネスプランの実行を支援する
ビジネス状況をタイムリーに把握するためのKPIを策定し、収集・分析をする
KPIレポートの作成と配布、PDCAプロセスの継続的なモニタリング、および必要な対策を実施する
フィールド活動を支援するコントラクトMRの計画・管理を行う。
データを活用し、最適な活動エリアと注力セグメントを特定する。また、活動において、革新的なプログラムを提供し、KPIを設定・モニタリングを行う
様々なデータソースから定量・定性データ、外部・内部市場調査結果を踏まえた分析結果を活用し、最適な営業体制、人員、フィールド活動を展開するための判断材料とインサイトを提供する
各部門のステークホルダーとのコミュニケーション通じて、強固な実行計画を作成する。
業務における追加リクエストに対するタイムリーな対応を行う
その他、付随する業務を実行する
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Job number: Job-00222346 Posted: 2023-06-22
Application Support Specialist
Top player in Mass Spectrometer market7 - 7 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- This company has led the field of mass spectrometry.
- Responsibilities
- Pre-sales activitiesPresentation at seminar and users meeting
Consultation to prospects
Sample analysis and demonstration to prospects
Preparation of tech notes and application notes to promote our solution
Customer visit with sales rep
Technical support on new product launch
Collaboration with key customers
Post-sales activitiesOn-line customer support (phone and e-mail)
Customer training (on-site and in-house)
Trouble shooting
Consultation on application
Preparation of manuals
Internal activitiesWork as a member of global application network
Education and coaching peers and junior chemists
Sales training about new product (hardware and software)
Business trip
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Job number: Job-00254996 Posted: 2023-09-26
Field Service Engineer | フィールドセールスエンジニア
社会的貢献度の高い分野でご活躍・やりがいのあるお仕事7 - 8.5 million yen Tokyo Medical Device Service Engineer
- Company overview
- Our client is a driving force in health care industry, specializing in technologies and a wide portfolio of related products and services.
- Responsibilities
- 業務内容:
ロボット医療機器全般のメンテナンス及び修理について管理及び実行
対象疾患領域の手術を理解し、技術的なサポートをタイムリーに実施
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Job number: Job-00255892 Posted: 2023-09-29
Regulatory Affairs Senior Specialist | 薬事シニアスペシャリスト
大手医療機器メーカーの薬事ポジション7 - 11 million yen Tokyo Medical Device Regulatory Affairs (RA)
- Company overview
- Our client is a world leading medical device manufacturer.
- Responsibilities
- 必須要件:
製造販売承認取得及び既存製品の維持管理業務
製品の特性やニーズに沿った承認申請戦略の立案
申請戦略及び製造元の原資料に基づく承認申請書の作成
行政当局からの照会に対する回答、社内部署や製造元との連携
法や通知に対する日常的な知識習得及び理解
添付文書、QMS申請、保険適用希望書の作成
販売促進資料の法的要求に関わる確認
製品の変更管理に関する判断
職務経験によっては在宅勤務可(応相談)
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NEWJob number: Job-00256881 Posted: 2024-04-26
Marketing Specialist (Kryptor) | マーケティングスペシャリスト (Kryptor)
新製品の上市準備、上市後の製品価値の最大化及び市場創造に向け製品啓発を含むプロダクトマネジメント業務7 - 10 million yen Tokyo Medical Device Marketing
- Company overview
- Our client is a global leading Life Science company involved in the import, export, sales, and maintenance of analytical instruments and other equipment. Through their extensive range of products, including reagents and software, they greatly contribute to supporting researchers and driving scientific progress.
- Responsibilities
- 特殊診断事業グループ(Specialty Diagnostics Group)で、主として臨床診断事業製品の新製品の上市準備、上市後の製品価値の最大化及び市場創造に向け製品啓発を含むプロダクトマネジメント業務をご担当いただきます。製造元、アジアパシフィックマーケティング担当者、そして国内マーケティングチームメンバーと協力し、日本の顧客ニーズに合ったマーケティング戦略の立案と実行を通じて、臨床診断事業の成長と製品ブランド認知向上に貢献いただきます。
業務内容:
市場分析や新製品導入戦略、既存製品の販売戦略立案
担当製品の市場投入に必要な営業向け、顧客向け資料の作成および説明
関係各部署を巻き込んだ新製品導入プロジェクトのリード
コミュニケーション施策、各種プロモーション開発
営業へのマーケティング戦略の展開・推進・教育・支援
市場環境・競合等の分析に基づく販売予測・KPI 設定
担当製品における海外ステークホルダーとのコミュニケーションをリード
KOLとの関係構築・マネジメント
最新の医学・医科学情報をもとにKOL とディスカッションをおこない、担当製品領域における
Unmet medical needs・インサイトの収集と分析、臨床研究サポート
担当製品領域における、エビデンスに基づいた疾患・病態・製品価値に関する説明
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NEWJob number: Job-00257095 Posted: 2024-04-25
Product Marketing (TAVI) | プロダクトマーケティング(TAVI)
製薬業界マーケティングからのご応募も可能です!7 - 9 million yen Tokyo Medical Device Marketing
- Company overview
- Our client is a medical device manufacturer.
- Responsibilities
- The TAVI Product Manager is responsible for setting strategic direction in Japan for the portfolio and for tactical implementation of activities aligned to a patient-centric, customer-centric and goal-achieving culture, leading to optimal clinical adoption, outcomes, and customer satisfaction within the space.The TAVI Product Manager is responsible for the following related to their portfolio:
Main responsibilities:
Develop Japan-specific marketing strategies and tactics for new product launches including market analysis, clinical strategy, reimbursement strategy, product positioning and messaging.
Contribute to the achievement of objectives via development and close execution of annual marketing plans.
Design and prepare the workflow, procedure, logistics and documentation required for product launch and business operation driving the cross-functional teams.
Plan and execute TAVI marketing tactics, especially for messaging for brand positioning and differentiation, peer to peer event to demonstrate product benefit, and activities to deepen customer engagement in TAVI market.
Set appropriate KPIs (leading KPIs, activity KPIs, clinical KPIs and performance KPIs) for marketing tactics, analyze data and track to take timely corrective actions as necessary
Leverage customer relationships, technical expertise and product knowledge to plan and coordinate new launches, and provide the sales team with appropriate messaging, campaigns and tools highlighting objective, relevant differentiation.
Develop promotional tools and optimize others provided by Global Marketing; launch with appropriate localization, training, and tracking.
Create open, productive lines of communication between the sales and clinical team and all other areas that affect the product: Regional and Global Marketing, RA, QA, etc.
Provide clinical and sales staff with clinical knowledge and promotional guidance, ensuring products are targeted appropriately to satisfy customer needs and expectations.
Stay up-to-date on key publications, trials, indications, society guidelines, and market dynamics and reflect to the communication / marketing strategy
Interface with Public Relations firms, market research companies; design agencies and other vendors and customers to effectively grow business in a profitable manner while maintaining a customer focus throughout all activities.
Develop and maintain professional relationships with key customer accounts as well as market influencers.
The TAVI Product Manager is responsible for achievement of the goals and objectives associated with their products including revenue, margin, and expense budget. Business Process goals will be measured against commitments in the annual marketing plan. Strict compliance with the company's Quality System and all Ethics/Compliance guidelines is required
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Job number: Job-00258913 Posted: 2023-12-22
品質マネジメント担当者
Japanese multinational IVD manufacturer7 - 10 million yen Tokyo Medical Device Quality Assurance / Quality Control
- Company overview
- Our client is engaged in the pharmaceutical business.
- Responsibilities
- 本ポジション(品質保証部品質マネジメント課)は、当社全社の品質マネジメントシステム(QMS)の構築、維持、管理、改善を担っており、当局の査察にも対応するなど当社ビジネスの安定な運営に不可欠な部署です。既存事業などの体外診断用医薬品を販売するにあたり、法規で求められている品質マネジメントシステムの管理を行っている組織です。加えて当社の新規事業であるCDMO(受託開発製造)事業の拡大に伴い、B to Bにも十分対応できる当社の品質システムへのブラッシュアップが必要であることから、現状のQMSを維持しつつ、QMSの変革についてイニシアティブを率先して取り組む人員を募集いたします。将来的には品質マネジメントシステムの全社責任者への登用が期待されます。
業務内容:
以下の業務執行にあたり、企画立案、課題解決、PJ推進、要員管理などのマネジメント業務に当たります。
品質マネジメントシステムに関する文書改訂、CAPAとりまとめ、データ解析、改善提案、査察対応"
他部署(OP本部、R&D本部など)の新規業務や改善に対する妥当性確認、検証、改善
当ホールディングス各社及び外部CDMO関連会社との委託業務の管理や連携業務
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NEWJob number: Job-00259794 Posted: 2024-04-26
BDM (Medical Device / Notified Body)
ホームオフィス/全国各地より就業可能7 - 10 million yen Tokyo Medical Device Sales
- Company overview
- Our client is world famous company specializing in Testing, Inspection, Certification and Training for international standards.
- Responsibilities
- The Business Development Manager is primarily responsible for selling company products and services to new and existing customers across a defined product suite. This role is responsible for identifying and managing sales opportunities, building an in-depth understanding of client business needs and drivers, to position how company products and services can enable organizations to improve and manage the sales process to a successful conclusion.To achieve sales targets to grow the share of wallet with large existing customers and to expand into new accounts by representing the entire range of company products and services.
Main responsibilities:
Sales Process: Lead and support the businesss' focus sectors-based business growth.
Establish a network and relationship with the key/global accounts to nurture bigger business potential converted in the bigger closed won.
Proactively network with existing customers to sell additional company products.
Identify new prospects to grow the company's customer base through targeted calls to generate sales revenue in line with new business targets.
Execute business sales process to investigate, explore and understand customer needs in order to sell relevant products/services.
Investigate relevant resources required and provide a timeline for delivery to meet customer orders & solve any customer issues.
Routinely review sales activity and quality KPIs, based on sales ratios to plan future sales activities to deliver on financial and activity targets.
Sales Tools:Manage potential through account and opportunity management to develop a solid pipeline. Produce accurate sales forecasts in a timely manner.
Effective use of price books and tools to propose main products and services.
Use relevant sales/product collateral to illustrate how a range of company products meets identified customer needs.
Accurately and effectively applies standard, commoditized, T&Cs.
Accurately record sales and order information in the CRM (Salesforce).
Product Knowledge:Remain up to date with developments in the standards industry and be able to explain the standards development process to customers.
Apply product features and benefits to customers’ needs in order to win business.
Apply knowledge of competitors to explain the full business advantages of company products.
Sales Skills:Possess a deeper and wider knowledge of the products/services of the business and their application to specific customer sets. Use reporting function of sales tools to aid account management and new business development.
Strong telephone communication with customers. Ability to create effective proposals and produce presentations to customers.
Accurately define requirements, including buying process, budget, positioning vs competition, and actual circumstances which positively affect potential sales. Identify further and future opportunities.
Able to question effectively to gain a deeper understanding of customer needs to identify up-selling opportunities. Able to provide a range of targeted solutions to the customer.
Accurately summarize customer needs. Identify company products or services. Get customer agreement to price and delivery.
Handle objections. Use knowledge and experience to provide an answer. Gain customer commitment before progressing. Identify high-impact issues for customers and give up on those with a low value to the business. Ensure understanding of business and personal value of company product/service to the customer.
Sales Management:Plan on a short-term basis (1-3 months) to achieve immediate performance goals.
Ensure the area of responsibility is delivering to plan. Identify & propose changes/solutions to drive & increase targeted delivery.