Total 17 job vacancies by Boehringer Ingelheim

Duties & Responsibilities

STRATEGY

• Translate the global TA strategy into a ROPU context
• Development and execution of the ROPU brand and TA strategy within the framework of Integrated Brand Planning
• Influence the development of TA/global brand strategies by providing ASKAN inputs in relation to market, competitor, and customer insights
• Leads marketing and cross functional teams to unveil Patients, HCPs and healthcare system needs that will build the insights foundation for excellent launch preparations for the future assets in our pipeline. Shape the company and the market for excellence in launch.

DRIVING BUSINESS RESULTS

A. INPUT TO BUSINESS PLANNING CYCLE (OUTLOOK AND LONG TERM FORECAST (LTF) PROCESS)

• Contribute to the LTF/Outlook preparation by providing sales and investment planning for the defined brand/TA
• Responsible for the forecast proposal (ROPU/OPUs) for respective brands/assets
• Develop LTF proposals for Sales, Direct Promotion and Headcounts, including FF FTEs
• Influence other functional areas to plan for proper resources for the brands/assets

B. BUSINESS PERFORMANCE

• Drive the TA/Brand performance in line with the ROPU objectives
• Ensure achievement of ROPU sales, market share and profit/profitability objectives
• Prepare for the launch of future assets and indications according to Launch Readiness Process and success metrics

PROCESS/CROSS-FUNCTIONAL COLLABORATION

A. INTEGRATED BRAND & CUSTOMER PLAN (IBP/ICP) DEVELOPMENT

• Lead ICP development by TA
• Develop TA/Asset CSFs & SIs
• Develop ROPU Operational Plan
• Develop and monitor TA/Brand KPIs
• Guide OPU TA/brand teams and provides active input into the development and review of OPU brand operating plans
• Leads Launch Readiness Process for respective pipeline assets in cross functional approach

B. OPERATIONAL PLAN EXECUTION/IN-MARKET IMPLEMENTATION DRIVE

• Closely follow up with OPUs on the implementation of Launch Readiness iniatives and ICPs
• Lead TA team to execute ROPU operational plan including ROPU customer engagement plan (e.g. advisory boards, standalone meetings, symposia aligned to external society meetings, KOL development plans, etc)
• Lead the development and drives execution of Medico-Marketing-MAHA initiatives for the ROPU to maximize customer engagement and guide OPU to achieve launch and executional excellence
• Drive performance through high quality brand reviews, issue identification, brainstorming and iteration to offer / share solutions from Global/ROPU/OPU to customers and patients

C. LAUNCH READINESS

• Launch readiness driver - lead launch readiness process to ensure achievement of launch readiness milestones and excellence in the launch of new assets/indications
• Ensure the preparedness and skills of the team to launch and promote new assets within the TA. Shape the product, market and company.
• Work closely with Medical Affairs, MAHA, PE, GTM to prepare for successful launch

D. CROSS FUNCTIONAL ALIGNMENT IN BRAND TEAM AND TA INTERACTION WITH OPU AND GLOBAL

• Organize and lead cross functional team interactions
• Maintain strong interface with OPU teams to facilitate growth of sales and market share
• Provide guidance to ensure alignment of individual OPU marketing activities with agreed ROPU goals and priorities
• Provide OPUs with regular updates on market & performance, ROPU strategy updates, insights generation and global competitive information
• Seek regular feedback and input from OPU marketing teams (on market/ competitor landscape/ patients & customer insights) to develop brand strategies and operational plans
• Interface with Global TAs to ensure ROPU ASKAN is well represented in global initiatives and development projects
• Ensure the ROPU strategies and ICPs are aligned with the global strategic direction & IBPs
• Provide support in enhancing market understanding across different OPUs in our region. As an integral business partner, you are expected to invest significant time and effort in supporting and working alongside affiliate colleagues of all levels across the region. You will be a key interface between OPU, business area, regional and corporate headquarters ensuring full alignment of commercial priorities and strategies. Closely follow-up and partner with OPUs in the region for improved performance.

E. MONITORING AND REPORTING

• Manage allocated TA DP budget
• In collaboration with Commercial Operations, deliver monthly performance update and KPI reporting, with close monitoring of OPU/ROPU market shares, immediately highlighting potential issues to Human Pharma Management Committee (HPMC) and proposing solutions and counter measure
• Communicate regularly key summaries/updates to HPMC in a clear and precise way to facilitate information sharing, consultation and efficient decision making, e.g. product knowledge, market/customer/competitor insights, M/S trends vs. other areas/markets
• In collaboration with AI&F, define the market research requirements to develop market, customer and competitor insights

F. SUPPORT TO Go-To-Market (GTM) TRANSFORMATION

• Support/drive GTM transformation and adoption of Platforms and Process to enable excellent customer centric engagement

PEOPLE

• Develop expertise, know-how and competency of direct reports through ongoing feedback, coaching and development opportunities
• Identifies gaps on skills/capabilities for successful launch and together with other internal and external stakeholders develops a plan to close the respective gaps
• Provide clarity on the goals and objectives to be achieved by the team
• Oversee and drive overall performance management and talent management of the team

Requirements

• University Degree in Science, Business or equivalent, preferably with a Postgraduate degree in Business Administration or MBA
• Minimum 7 years of relevant business experience in the pharmaceutical industry (Innovator Products/ Medicine), with a minimum 3 years in a leadership role
• Ideally has regional work experience
• Preferably has marketing experience in Oncology, Immunology or rare disease areas
• Proven track record in developing and/or supporting marketing strategy, branding & launches
• Has strong marketing planning, budgeting, financial management and analytic skills and able to drive complex projects within tight timelines
• Prior working experience in sales is considered a plus
• Open-minded and a fast learner
• Special Skills as per Boehringer Ingelheim’s Marketing Competencies Model:

- Business and Marketing Acumen

- Patient Centricity

- Customer Orientation

- Strategy Development

- Project Management

- Effective Execution

- Relationship Management

- Proficiency in MS Office, Outlook and database application

• Ability to engage with Regional Office and Country Stakeholders, strong interpersonal and influencing skills
• Has passion for performance; role model of Boehringer Ingelheim Values and AAI Behavior
• Ability to travel
• Proficient in English language

The Position

• The Quality and Compliance Lead (QCL) is the Quality and Compliance expert within the Medicine Division that drives GvP / GcP topics across the BI organization to pro-actively manage Quality and Compliance across the drug/device development. In addition, the QCL will also lead the organization to identify and mitigate risks during development to ensure patient safety and data integrity.
• This role will also initiate and manage any quality and compliance topics to continuously improve the Medicine Quality Management System across ROPU ASKAN. The QCL provides quality and compliance consultancy within the regional operating unit (R)OPU), while contributing to (R)OPU insights into the Global Quality Medicine Strategy and execute the strategy at (R)OPU level.

Duties & Responsibilities

• Develop and maintain all aspects of the global Medicine Quality Management System and tailoring to the (R)OPU to comply with applicable regulatory requirements.
• Lead the implementation and maintenance of global procedures and ensure adherence to the local regulatory and business requirements.
• Lead inspections end to end (inspection preparation, conduct and post inspection management), representing the BI compliance position during inspections and ensuring inspection findings are addressed and responses provided.
• Ensure audit findings are appropriately investigated, actions are effectively implemented, and lessons learnt are implemented
• Define requirements for services needed by (R)OPU in collaboration with Medicine Functions.
• Provide quality analysis and trending across Medicine Functions.
• Lead as the subject matter expert (in partnership with the business key stakeholders) in Non-Compliance management and Issue Management processes. Ensure effective triaging, root cause analysis investigation and CAPA development delivering robust CAPAs

Requirements

• Master's degree preferred or Bachelors in a life science or other scientific discipline with several years of work experience
• Minimum 1 to 2 years of experience in Quality and Compliance related job
• Experience in pharmacovigilance, regulatory affairs, medical affairs or clinical trial management and expert in ICH GcP, GvP and applicable regulations
• Direct experience with / participation in regulatory authority inspections or audits
• Proven track record of effective collaborations with business partners
• Ability to act independently on given tasks and be a good team player

The Position

• At Boehringer Ingelheim IT Marketing & Sales Data Driven Customer Insights organization we are unlocking the value of data delivering innovative technology solutions that are improving the lives of patients and animals worldwide.
• We are currently seeking a dynamic and experienced Senior Principal System Analyst to join our team as Data Translator to ensure we achieve real impact from our data & analytics initiatives. The position provides a unique opportunity to unleash the potential of data, facilitate collaboration, empower stakeholders to make informed decisions and help drive adoption and literacy throughout Commercial and Medical Animal Health and Human Pharma organizations in ROPU ASKAN and IMETA.
• You will play a pivotal role in bridging the gap between technical data experts and business leads, helping the identification of high-value business problems that analytics can solve, translating complex data concepts into solutions with actionable insights, coordinating with internal and external teams.
• If you believe data can make the different and want to make a meaningful impact, join us in our mission to incorporate a data-driven approach, combining different data sources in innovative ways to transform lives for generation.
• Let's transform data into life-changing solutions together!

Duties & Responsibilities

• As a Data Translator, you will bridge the gap between technical data experts and business stakeholders, grasping business context and processes to identify relevant problems, opportunities and demands that can be translated into data and analytics solutions, turning data insights into meaningful outcomes.
• Craft narratives around data to engage and influence stakeholders, translating their needs, defining new value proposition leveraging technology, communicating benefits to drive data adoption within the organization, ensuring that data insights lead to meaningful impact on business outcomes.
• You will work within a multi-disciplinary team, collaborating with industry-leading Data Architects, Data Scientists, Data Engineers, Data Domain Owners, and Business Subject Matter Experts, in distributed data product teams, to design and develop solutions that adapt to a rapidly changing data landscape, facilitating an effective alignment between data insights and strategic goals.
• With a keen understanding of present and future business needs, you draw on your domain knowledge to help identify high-value business problems that data & analytics can solve, in collaboration with stakeholders at corporate and in the countries, demonstrating deep understanding of business data domains and related business processes, focusing on the intersection of technology and business.
• Address ROPU ASKAN and IMETA data & analytics use-cases from identification to solution with collaboration and alignment with local business SMEs, global capabilities leads and technical experts, bridging the gap between business needs and IT solutions.
• Enable ROPU ASKAN and IMETA in generating relevant and actionable insights through data exploration, implementing and utilizing data & analytics platforms, solutions and services, accordingly with our architecture by continuously supporting adoption and enhancements.

Requirements

• Masters’ degree in Computer Science, Business Administration or Data Science or Bachelor’s degree combined with long term years of relevant working experiences.
• Minimum 6 years’ experience in IT and data analysis, as an interface to internal and external business partners on a global level, preferably within the pharma industry.
• Strong business acumen and domain knowledge to effectively identify not only the value of data & analytics in the business context, but also the impact of technology and algorithms, with a proven ability to understand technical jargon and translate it accurately in business language.
• Exceptional critical thinking, problem-solving, and analytical skills, complemented by creativity and innovation. Outstanding communication skills to effectively collaborate with cross-functional teams, with a proven ability to establish and maintain business relationships. Proactive, with the ability to confidently navigate ambiguous and difficult situations, resolve conflicts, and build consensus.
• Data fluency: while not deep technical experts, you have good understanding of data engineering, data science, data visualization, data governance principles and practices.
• Experience with Design Thinking, system and service design, development, and implementation of solutions with emotional intelligence, directing an analytics initiative from ideation through production and adoption.
• Strong networker who gives direction and drives for decisions, brings people together while always keeping the customer in mind. Demonstrated Agile mindset and experience working in DevOps products teams.

The Position

This person will be responsible for the Medical Affairs strategy and execution in ROPU ASKAN Oncology therapeutic area (TA).

Duties & Responsibilities

• Work closely with the OPU brand teams together with regional marketing team, develop, implement, and execute strategies and activities to bring the benefit of BI medications to patients across the product lifecycle.
• Operate in cross-functional teams (Marketing & Commercial operation team, Regulatory Affairs, Market Access team, Clinical Development and Operations, Patient safety and Pharmacovigilance and Medical content manager, Patient Engagement team).
• Plan and coordinate scientific expert interactions (scientific exchange meetings, symposia, consultancy groups, roundtable discussion, workshops, train the trainer sessions, advisory board meetings, speakers' tours etc.), appropriate expert engagement across countries and advocacy development plans, as well as collection of key metrics.
• Develop and maintain medical expertise for the relevant BI products and therapeutic areas of Human Pharma to meet external customer needs, in combination with a thorough understanding of Medical Affairs and Brand strategies/tactics
• Where and when applicable, work on generating and disseminating local data scientifically relevant to BI products.
• Support to drive the scientific contents through omnichannel digital engagement aligned to the TA strategy.

Requirements

• Must be a Doctor of Medicine or a PhD in Sciences. A subspecialist in the TA is nice to have.
• Must have work experience in Medical Affairs 5 years in country role and/or 2 years in a regional role.
• Experience in managing a product in Oncology is a must have.
• Must have good presentation skills and good command of English both as a written and spoken language.
• Must have experience in organizing Medical Affairs related activities like Advisory Board Meeting, Speaker Forum etc.
• Must be proficient with Word, Excel, Powerpoint, digital channel platform (virtual meeting, omnichannel engagement)

The Position:

This person will be responsible for the Medical Affairs strategy and execution in ROPU ASKAN Jardiance T2D & Obesity therapeutic areas (TA).

Duties & Responsibilities:

• Work closely with the other functions in the CRM TA Franchise team (e.g., marketing, MAHA and GTM).
• Develop, implement, and execute strategies & activities to bring the benefit of BI medications to patients across the product lifecycle while collaborating and providing guidance to the OPUs.
• Plan and coordinate scientific expert interactions (scientific exchange meetings, symposia, consultancy groups, roundtable discussion, workshops, train the trainer sessions, advisory board meetings, speakers' tours etc.), appropriate expert engagement across countries and advocacy development plans, as well as collection of key metrics.
• Develop and maintain medical expertise for the relevant BI products and therapeutic areas of Human Pharma to meet external customer needs, in combination with a thorough understanding of Medical Affairs and Brand strategies/tactics
• Where and when applicable, work on generating and disseminating local data scientifically relevant to BI products.
• Develop and maintain a robust customer-oriented digital program and tools aligned to the TA strategy.

Requirements:

• Must be a Doctor of Medicine or a PhD in Sciences.
• Must have work experience in Medical Affairs 5 years in country role and/or 2 years in a regional role.
• Must have good presentation skills and good command of English both as a written and spoken language.
• Must have experience in organizing Medical Affairs related activities like Advisory Board Meeting, Speaker Forum etc.
• Experience in managing a product in diabetes and/or obesity therapeutic area is a must have
• Experience in launching a new product in the metabolism therapeutic area is an advantage.
• Must be proficient with Word, Excel, Powerpoint, digital channel platform (virtual meeting, omnichannel engagement)

The Position

An opportunity to lead the scientific content management from end-to-end process for creating, planning, tagging, and communicating in multi-channel customer communication platforms. Work in a cross-functional environment and act as project leader for medical campaign dashboard, multi-channel engagement, and explore innovation in contents and actionable insights.

Duties & Responsibilities

• Govern and support the processes surrounding planning, development, and management of digital content / messages to be implemented across the multi-channel customer planning & communication platforms with Medical Teams in the ROPU Centre, as well as relevant third parties and agencies.
• Drive the process to create and maintain digital content editorial plans to ensure timely and accurate content delivery, and optimize outcomes.
• Work with Customer Insights team to gain understanding of priority customer groups and segments for current promoted brands and future portfolio in terms of customer needs, gaps, content and channel preferences.
• Lead and support the process for development of channel and content / messaging strategy for various target audiences based on their customer journey and touch points according to their strategic segments.
• Perform content audits and identify content / process / understanding / training gaps.

Requirements

• Bachelor’s Degree or Master’s degree (or equivalent) in medicine, pharmacy, life science, or any other relevant field.
• 2-5 years of experience on content planning, creation, tagging, and multi-channel content engagement
• Strong and broad understanding of pharma business and advanced knowledge of websites and digital analysis
• Strong personal interaction skills / Team player needed for high degree of cross-functional/-TA/ on multiple initiatives at any one time
• Full familiarity with digital and non-digital content production and approval processes
• Self-/Result- and Solution driven

The Position:

This person will be responsible for the Medical Affairs strategy and execution in ROPU ASKAN Jardiance T2D & Obesity therapeutic areas (TA).

Duties & Responsibilities:

• Work closely with the other functions in the CRM TA Franchise team (e.g., marketing, MAHA and GTM).
• Develop, implement, and execute strategies & activities to bring the benefit of BI medications to patients across the product lifecycle while collaborating and providing guidance to the OPUs.
• Plan and coordinate scientific expert interactions (scientific exchange meetings, symposia, consultancy groups, roundtable discussion, workshops, train the trainer sessions, advisory board meetings, speakers' tours etc.), appropriate expert engagement across countries and advocacy development plans, as well as collection of key metrics.
• Develop and maintain medical expertise for the relevant BI products and therapeutic areas of Human Pharma to meet external customer needs, in combination with a thorough understanding of Medical Affairs and Brand strategies/tactics
• Where and when applicable, work on generating and disseminating local data scientifically relevant to BI products.
• Develop and maintain a robust customer-oriented digital program and tools aligned to the TA strategy.

Requirements:

• Must be a Doctor of Medicine or a PhD in Sciences.
• Must have work experience in Medical Affairs 5 years in country role and/or 2 years in a regional role.
• Must have good presentation skills and good command of English both as a written and spoken language.
• Must have experience in organizing Medical Affairs related activities like Advisory Board Meeting, Speaker Forum etc.
• Experience in managing a product in diabetes and/or obesity therapeutic area is a must have
• Experience in launching a new product in the metabolism therapeutic area is an advantage.
• Must be proficient with Word, Excel, Powerpoint, digital channel platform (virtual meeting, omnichannel engagement)

Description

The TA Franchise Head for Specialty Care (Interstitial Lung Disease/Respiratory, Oncology/Immunology, Mental & Retinal Health) will be responsible for the successful translation of global to local strategy, preparation of pipeline assets' launch across region and driving commercialization of the Franchise portfolio by developing overarching integrated cross-functional strategies and ensuring excellent execution.

Has oversight of the whole TA Franchise Team in ROPU Centre, directly lead the commercial team (i.e. marketing) and provide strategic leadership to the cross-functional franchise team (e.g. MAHA, GTM, Medical Affairs). Together with functional leadership, design the overall Franchise Strategy across TAs under the franchise at regional level, to guarantee that the different TAs and brands have the right strategy, overall planning, and adequate resources to set and achieve ambitious results. Ensure overall launch preparation for new assets.

Guide OPU TA Franchise Head of Specialty Care (SpC) in the implementation of ROPU Strategies in respective TAs. Drive the Specialty Care Marketing and Sales/FF organization across ASKAN, to develop the Integrated Customer Plans (ICPs) built on solid customer and patient insights, meaningful to ASKAN region. Drive the local / OPU commercial organization to deliver results according to established internal/external targets and KPIs. Provide regional guidance to OPUs on Go-To-Market strategy and respective customer engagement models for for SpC TAs and assets, in alignment with the ROPU Centre GTM and OPUs.

Duties & Responsibilities

• Overall P&L responsibility for the TAs and brands/assets under the franchise, from gross sales to CCMIII A; ensure achievement of sales, growth, market share and profit/ profitability objectives of Franchise, respective Therapeutic Areas and portfolio
• Develops Franchise Strategy, Brand strategies and ICPs in line with Integrated Brand Plan (IBP) process in cooperation with Global teams and ASKAN Countries
• Develop Integrated Customer Plans (ICPs) based on IBPs and bottom-up needs from OPUs in the region; ensure successful implementation of ICPs
• Select high-performing talents and develop expertise, know-how and competency of the team
• Champion and drive patient centricity and transformation (including digital) in all aspects of the business

Requirements

• Bachelor degree in relevant areas, like Marketing, Business Administration, Pharmacy, Medicine, Psychology or its equivalent; Master’s Degree is a plus
• Expert leaders with a minimum of 10 years of business and marketing experience in the pharmaceutical industry, with proven track record of success in complex, competitive markets
• Minimum of 6 years leadership experience leading people & leading projects
• Ideally with relevant experience in handling specialty care or rare disease product portfolio, including new product launches
• Deep knowledge in identifying and building foundational insights, patient journey, new patient and customer engagement initiatives for improved patient care
• Strong background in developing multi-stakeholder strategy, integrated brand plans, new product planning and launch
• Ability to engage with Senior Management and Corporate stakeholders
• Strong business acumen; strong analytical, problem solving, project management, communication and people management skills
• International work experience a plus
• Role model of AAI (Accountibility Agility Intrapreneurship) Behavior
• Proficient in the English Language

Duties & Responsibilities

• Work closely with the OPU brand teams together with regional marketing team, develop, implement, and execute strategies and activities to bring the benefit of BI medications to patients across the product lifecycle.
• Support in medical pre-launch planning and medical event execution
• Build relationships with local stakeholders to establish awareness and information flow about BI's medications and targeted diseases.
• Engage in opportunities to build the relationship with associations, connect with the top EE in the field and elevate awareness in ASKAN countries

Requirement

• Must be a Doctor of Medicine or a PhD in Sciences.
• Must have good presentation skills and good command of English both as a written and spoken language.
• Minimum 1 year experience in organizing Medical Affairs related activities like Advisory Board Meeting, Preceptorship Program, Speaker Forum etc.

The Position:

This person will be responsible for the Medical Affairs strategy and execution in ROPU ASKAN Lung Portfolio.

Duties & Responsibilities:

• Work closely with the OPU brand teams together with regional marketing team, develop, implement, and execute strategies and activities to bring the benefit of BI medications to patients across the product lifecycle.
  Operate in cross-functional teams (Marketing & Commercial operation team, Regulatory Affairs, Market Access team, Clinical Development and Operations, Patient safety and Pharmacovigilance and other functions).
• Plan and coordinate scientific expert interactions (scientific exchange meetings, symposia, consultancy groups, roundtable discussion, workshops, train the trainer sessions, advisory board meetings, speakers' tours etc.), appropriate expert engagement across countries and advocacy development plans, as well as collection of key metrics.
• Develop and maintain medical expertise for the relevant BI products and therapeutic areas of Human Pharma to meet external customer needs, in combination with a thorough understanding of Medical Affairs and Brand strategies/tactics
• Where and when applicable, work on generating and disseminating local data scientifically relevant to BI products.
• Develop and maintain a robust customer-oriented digital program and tools aligned to the therapeutic area strategy.
• People manager to coach and advise a direct report (Medical Advisor) if applicable.

Requirements:

• Must be a Doctor of Medicine or a PhD in Sciences. A subspecialist in the TA is nice to have.
• Must have work experience in Medical Affairs 5 years in country role and/or 2 years in a regional role.
• Experience in managing a product in Lung Portfolio is an advantage.
• Must have good presentation skills and good command of English both as a written and spoken language.
• Must have experience in organizing Medical Affairs related activities like Advisory Board Meeting, Speaker Forum etc.
• Must be proficient with Word, Excel, Powerpoint, digital channel platform (virtual meeting, omnichannel engagement)

The Position

• Provide support to the local Regulatory Affairs in implementing sound regulatory strategies and risk mitigation plans for assigned portfolio and alignment of regulatory submission plans with business strategies in the ROPU.
• Maintain full awareness of all regulatory activities of assigned portfolio and work closely with global and local teams to ensure project deadlines, performance and compliance standards for assigned portfolio are met throughout a product’s entire life cycle.
• Act as regulatory expert in relevant systems/databases and assist in implementing tracking processes to ensure compliance with local regulatory requirements and internal standards.
• Develop and maintain compliance training programs and support the effective implementation of harmonized processes across the ROPU.

Tasks & Responsibilities

1. Regulatory Planning and Submission Strategy

• Support the execution of global regulatory strategies for assigned portfolio within the agreed timelines and guide local Regulatory Affairs personnel in submission strategies to accelerate regulatory processes on key indications/brands.
• Identify and communicate major regulatory issues relating to technical, strategic or operational information impacting BI portfolio and implement regulatory measures in liaison with regional and global team.
• Establish an effective and collaborative working relationship with cross-functional teams; prepare and present concise status updates of assigned portfolio as required.

2. Quality and Compliance

• Assist in establishing tracking systems and processes for timely submission of CCDS, CRC, Renewals, PSUR and other local variations to maximize the business opportunity or mitigate the operational risks.
• Conduct system training and ensure maintenance of databases.
• Contribute to audits, CAPA process as appropriate and support inspection readiness.

3. Operational Excellence

• Support an effective implementation and maintenance of harmonized processes and systems across ROPU, avoiding duplication of global processes.
• Provide feedback on the implementation of global initiatives and suggest improvements to current databases/systems and processes
• Assist in implementation of appropriate training/development plans and promote sharing of best practices
• Coordinate regulatory requirements surveys and communicate compiled results to ROPU/Global RA
• Consolidate monthly reports

Requirements

• Degree in Pharmacy or related life sciences discipline
• At least 4 years of experience in the pharmaceutical industry preferably in Regulatory Affairs
• Knowledge of regulatory affairs regulations in the region is preferred
• Demonstrated ability to communicate and coordinate within an international setting
• Experience working effectively across cultures and in complex matrixed environment
• Excellent verbal and written communication style at all levels; English proficiency required
• Strong interpersonal and management skills with business acumen

Description

1. Contribute to the establishment, continuous improvement and maintenance of the Quality Management System (QMS) in ROPU ASKAN by ensuring that all external (e.g. GMP, GDP, GDPMD, GSP, GIP) and internal BI requirements (e.g. Policies, OCS, OCP, ACP) are implemented at ROPU and each OPU, monitored for performance/adherence and improved, if required.

2. Support OPU Commercial Quality (CQ) Managers/Leads, Specialists, Associates and LPCOs) in executing key defined steps in relevant quality processes where such activities are centralized at ROPU.

3. Support the Commercial Quality Strategy for the ROPU together with the Head of Commercial Quality ROPU ASKAN and respective Corporate and ROPU Management.

4. Support the Head of Commercial Quality ROPU ASKAN and Commercial Quality Manager ROPU ASKAN and DMS/LMS Specialist ROPU ASKAN in ensuring appropriate Quality oversight related to GMP and GDP/GDPMD/GSP/GIP in the ROPU including:

• Management of external service providers in all quality relevant aspects during the life cycle of a contract beginning with issuance until termination to ensure local supply and manufacture of products or services with acceptable quality, in full regulatory compliance and in accordance with contractual obligations and BI guidelines.

• Performing GMP/GDP/GDPMD/GSP/GIP audits at suppliers and external partners (qualification and regular audit), including follow-up of CAPAs at 3rd parties.

• Implementing/revising relevant GMP/GDP/GDPMD/GSP/GIP quality systems related to commercial product supply in the ROPU to meet the continual needs of the company and the local authorities and ensure that products and processes/systems are delivered to the customers with a consistent high quality standard and in accordance with BI requirements and the local legislations.

• Knowledge management within ROPU by supporting best practice sharing and ensuring training across the ROPU.

• Efficient implementation of standards within the ROPU by maintaining a common document management system; implementation of OCS, OCPs and further Corporate documents; monitor rollout and by standardization of processes.

• Continual quality and compliance improvement within ROPU by identifying optimization potentials and by monitoring OPU performance via self -inspection/self-assessment program.

• Assume role as ROPU system owner (Local MSO), SME, administrator and key user for relevant Quality Systems (E.g.Investigation, CAPA, change control, and product complaints etc).

5. Support the maintenance of trainings within the electronic training system and management of controlled documents in the electronic document management system for all Business unites, functions, departments and countries within ROPU ASKAN.

6. Support to ensure proper implementation of global procedures related to training and document management for ASKAN and continuous improvement of training and document management system in ROPU ASKAN.

7. Provide support to management/execution of OPU Commercial Quality operation/activties (as needed).

8. Serve as backup-up support for OPU Commercial Quality responsible persons on OPU commercial quality operation/activities (as needed).

9. Provide commercial quality input/support to certain business initiatives, projects, requests as per requirements and established timelines as needed.

10. Take on and/or support any other tasks assigned.

Duties & Responsibilities

• As Local MSO, SME, administrator and key user for Quality System Management and/or supporting:

- Creation and maintenance of relevant quality system for regional/local SOPs/Working Instructions (e.g. write, review, approve, periodic review etc);

- Ensuring that applicable Corporate Procedures are transferred into ROPU or local SOPs/Working Instructions

- Ensuring that training on relevant Quality SOPs/Working Instructions are properly performed and documented before implementation.

- Ensure system records are tracked, updated and closed as per established requirements/timelines.

- Ensure system KPIs are tracked, reported and met as per established requirements/timelines.

- Analyze any significant changes in the GMP/GDP/GDPMD/GSP/GIP environment and identify need for SOP/Working Instructions writing and/or communication to Corporate Quality (Operations Regulatory Intelligence “ORI”).

• Provide to other local MSO, SME, Administrator, and key users for Quality System Management on above activities if needed.

• Provide support to management/execution of OPU Commercial Quality operations/activities (as needed).

• Serve as backup-up support for OPU Commercial Quality responsible persons on OPU commercial quality operation/activities (as needed).

• Present process evaluations and implement agreed changes for continuous improvements to the ROPU Quality Systems and Quality Manual.

• Represent ROPU ASKAN Commercial Quality and act as an interface to Global Corporate/Global Quality Organization; give feedback to Corporate/Global level quality initiatives and take actions to ROPU/OPU levels.

• Represent ROPU ASKAN Commercial Quality team or Head of Commercial Quality ROPU ASKAN to provide input/support for certain business initiatives, projects, requests, matters as per relevant requirements and established timelines as needed.

• Provides consistent global, regional and local business support for LMS through:

- Coordinating global, regional and local assignment process.

- Providing technical expertise (system troubleshooting, advice and assistance to Learners, Curriculum Owners, Line Managers, etc.).

- Promoting best practices in the utilization of LMS.

- Supporting the globally defined training process within ROPU ASKAN.

- Supports the maintenance and development of the regional training process, including active support for the MTGC (Mandatory Training Governance Council), and creation and execution of related procedures, guidelines and decisions.

- Support global, regional and local curriculum owners in the creation and maintenance of curricula, and the assignment of curricula to intended learners in a timely and structured manner.

- Ensure training assignment of regional and local training in a coordinated manner, and within the given timelines according to the globally defined processes.

- Ensure a comprehensive tracking of all learning, both e-learning as well as group and face to face learning.

- Provide support during audits and inspections in case of questions regarding training and document management.

- Carefully track and report training and document management KPIs, and set activities for improvement of KPIs as needed.

- Support knowledge exchange and best practice sharing regarding LMS, within ASKAN as well as global BI network.

- Be the Deputy Process owner for the processes of Training and Document Management in ROPU ASKAN.

- Be the back-up to assume the role & responsibilities of DMS & LMS Specialist, ROPU ASKAN role when needed.

• Provide support as needed to ensure lean and appropriate SOP development within ROPU ASKAN.

• Establishing a system to support authors of controlled documents, in creation, maintenance/update as well as learning assignment to target audience.

LMS continual improvement:

• Provide support for the further development and maintenance of the training and document management systems and processes within the globally provided framework.

• Initiate efforts for effective and efficient system use.

• Act as technical and business expert in the use of LMS and maintain system quality, report on standard system metrics, support MTCG periodic curriculum review.

Requirements

· Bachelor of Science degree in Chemistry, Pharmacy, Chemical Engineering, or related science diploma with relevant work experience.

· 5-7 years Quality experience in pharmaceutical or biologics or medical devices MNC. Any GMP quality experience is a plus.

· Minimum 5 years experience in country/regional commercial quality operation/activities management and execution in pharmaceutical or biologics or medical devices MNC. Any regional commercial quality experience is a plus.

· Sound and direct experience/knowledge (2-4 years) in training management and controlled document management system and using electronic system for training and controlled document management.

· Thorough knowledge of GDP quality/regulatory requirements with practical expertise in commercial quality operation/activities in pharmaceutical/vaccines/medical devices industry.

· Works well in both a team-orientated environment and independently

· Attention to detail, good organizational skills, flexibility

· Sense for urgency and efficiency

· Demonstrates ability to manage multiple activities

· Excellent oral and written communication skills in English language

· Communicates effectively results and project status both internally and externally

· Prepares technical reports including executive summaries and management presentations

· Demonstrates strong analytical skills, is able to judge when more information is needed, where to obtain it and to draw sound conclusions from available information

· Demonstrates mature judgment and strong decision-making skills regarding project and product issues

· Is able to deal with complexity (critical thinker)

DUTIES & RESPONSIBILITIES

• Development and execution of the regional marketing strategy for the brand / portfolio and work closely with colleagues across the organization to help maximize sales results and build leading brands across the region.
• Enhance market understanding and knowledge through development and implementation of relevant marketing tools, identify opportunities for growth through close collaboration with affiliate teams and generation of extensive insights and analysis.
• Drive development of cross functional affiliate marketing plans that identify clear portfolio and brand strategies linked to clearly defined tactical execution. Critical to success in this role will be the ability to drive state of the art launches for our future products whilst ensuring excellent life cycle management and execution of activities to accelerate growth in the current business. You will be required to facilitate and deliver various activities and training to the affiliate teams to strengthen competencies and onboard new team members across the marketing teams.
• Provide support in enhancing market understanding across the portfolio by analyzing key drivers and barriers and formulating strategic plans to capitalize on market opportunities. As an integral business partner, you are expected to invest significant time and effort in supporting and working alongside affiliate colleagues of all levels across the region. You will be a key interface between affiliate, business area, regional and corporate headquarters ensuring full alignment of commercial priorities and strategies.
• Develop / adapt materials and drive digital initiatives for brand / portfolio across the region.
• Support/drive GTM transformation and adoption of Platforms and Process to enable excellent customer centric engagement.

REQUIREMENTS

• University Degree in Science, Business or equivalent, preferably with a Postgraduate degree in Business Administration
• Minimum of 5 years in strategic & operational marketing
• Proven track record in marketing strategy, branding & PR. Experience in product launches is advantage.
• Marketing experience with Metabolic Therapeutic Area is preferred.
• Ideally with regional marketing experience.
• Has strong marketing planning, budgeting, financial management and analysis skills and able to drive complex projects within tight timelines
• Prior working experience in sales is considered a plus
• Open-minded, a fast learner and proficient in English language
• Special Skills as per Boehringer Ingelheim’s Marketing Competencies Model:
  - Business and Marketing Acumen:
  - Customer Orientation
  - Strategy Development
  - Project Management
  - Effective Execution
  - Relationship Management
• Ability to engage with Regional Office and Country Stakeholders, strong interpersonal and influencing skills
• Has passion for performance, able to deliver business results in high-pressure situations
• Role model of Boehringer Ingelheim Values
• Able to travel across the ROPU ASKAN Countries

Task & Responsibilities

· Accountable for IT Global Application Experience provided services for the area under scope (group of applications/software, product team, region)

· Ensures the operational quality/performance of the service according to defined SLAs. Correct provisioning of the services, its capacity, stability, operational excellence performance, vendor operational management and continuous improvement actions

· Accountable for the global IT Support Services for the assigned system cluster - support will be provided by one of our IT Support vendors

· Overall view of the service and analysis of trending and deviations of support

· Ensure the correct quality/performance of the service according to Service Level Agreement

· Coordinate the workload of support team, responsible for the vendor operational management

· Assure knowledge within the team and look for service improvements

· Serve as the point of escalation for major incidents relating to the support service

· Responsible of ensuring resource efficiency, scalability of the service and implementation of simplification measures, such as automation, "shift left" actions, etc.

· Regular proactive review of support tickets to assure service quality according to SLA

· Execution of defined meetings with different stakeholders (business key users, IT functions and external support teams)

· Ensure proper onboarding of new applications to the support service

Experience

· Minimum 5 years of experience in IT Application Operational Support or System Analyst roles

· Minimum 3 years of experience in managing IT Support vendors preferred

Skills/Requirements

· Bachelor’s degree or relevant IT work experience

· SalesForce.com / Veeva: 3 to 5 years of support experiences in global multiple country setup

· Service Management Coordination, experience with Services Management processes and demonstrated coordination

· Stakeholder Management

· GxP Knowledge (if applicable)

· Operational Vendor Management (if applicable)

· Strong organizational skills

· Strong client support/customer service skills

· Strong global relationships and communication skills with Business colleagues and IT colleagues

· Ability to prioritize when working on multiple tasks to ensure timely delivery

· Strong troubleshooting skills

Language

· English language: Advanced Reading & Writing skills, ability to communicate with global teams

· Additional languages are welcome (ie: Chinese, Japanese)

Technical Skills

· IT Service Management tools (ticketing) tool user knowledge

· ITIL v4 knowledge – advanced in Incident and Problem Management processes

· MS365 applications usage (advanced user in PowerPoint, Word), PowerBI, Flow

The Position

• Provide guidance and support to the local Regulatory Affairs in implementing sound regulatory strategies and risk mitigation plans for assigned portfolio and alignment of regulatory submission plans with business strategies in the ROPU.
• Maintain full awareness of all regulatory activities of assigned portfolio and work closely with global and local teams to ensure project deadlines, performance and compliance standards for assigned portfolio are met throughout a product’s entire life cycle.
• Act as regulatory expert to the global/ROPU/local teams on regulations, guidelines interpretation within the ROPU and communicate regulatory issues impacting BI portfolio to implement timely actions.
• Support local Regulatory Affairs in maintaining a strong network with the health authority, pharma association and other key regulatory influencer and stakeholder, influencing the regulatory project strategy and promoting BI’s interests.
• Actively participate in roll out of regulatory compliance activities for assigned portfolio according to local regulatory requirements and to internal standards and support the effective implementation of harmonized processes across the ROPU.

Tasks & Responsibilities

1. Regulatory Planning and Submission Strategy

• Support the development and execution of global regulatory strategies for assigned portfolio within the agreed timelines and guide local Regulatory Affairs personnel in developing innovative submissions strategies to accelerate regulatory processes on key indications/brands.
• Assess and communicate major regulatory issues relating to clinical, technical, strategic or operational information impacting BI portfolio and implement regulatory measures in liaison with regional and global team.
• Establish an effective and collaborative working relationship with cross-functional teams; prepare and present concise status updates of assigned portfolio as required.

2. Quality and Compliance

• Establish tracking systems and processes for timely submission of CCDS, CRC, Renewals, PSUR and other local variations to maximize the business opportunity or mitigate the operational risks.
• Conduct training and ensure maintenance of databases.
• Contribute to CAPA process as appropriate and support inspection readiness.

3. Regulatory Intelligence and Policy

• Support local Regulatory Affairs in maintaining a strong network with the health authority/reviewers/pharma associations and influence into the regulatory project strategy.
• Act as regulatory expert to global/ROPU/local teams on regulations, guidelines interpretation within the ROPU and provide consolidated overview on key regulatory development with cross functional integration to Regulatory Intelligence Network.

4. Operational Excellence

• Support an effective implementation and maintenance of harmonized processes and systems across ROPU, avoiding duplication of global processes.
• Provide feedback to global on the implementation of global initiatives and suggest improvements to current processes
• Engage in assessment of training needs and mentoring of the local regulatory affairs to implement appropriate training/development plans and promote sharing of best practices

Requirements

• Degree in Medicine or Pharmacy or related life sciences discipline
• At least 8 years of experience with multinational pharmaceutical company
• At least 5 years of experience in various aspect of Regulatory Affairs (e.g. NDA, renewal, lifecycle management etc.) for innovative pharmaceutical products
• Knowledge of regulatory affairs regulations in the region is preferred
• Demonstrated ability to communicate and coordinate within an international setting
• Experience working effectively across cultures and in complex matrixed environment
• Experience in participation and working with local pharmaceutical association
• Excellent verbal and written communication style at all levels; English proficiency required
• Strong interpersonal and management skills with business acumen