Openings at Certara

Job Overview

This is a great opportunity for an early career Epidemiologist/Pharmaco-Epidemiologist/Public Health professional to join a team of highly skilled epidemiologists, statisticians, health economists and consultants. The successful candidate will work closely with other senior scientific staff within the company. This position will allow the Senior Analyst/ Epidemiologist to deepen his/her skills by writing protocols for observational studies using a variety of healthcare databases, primary and secondary data collection, as well as providing scientific and other technical input during conception, conduct and delivery of various research projects.

Main Tasks & Responsibilities

• Support RWDS project teams and be accountable to the project manager/director for those projects
• Summarize and synthesize a wide range of medical and statistical information, including disease specific and pharmaceutical product research
• Develop an understanding of Regulatory/HTA requirements for RWE, at least in the European and/or North American context
• Support development of study documents (eg. protocols, analysis plans, reports, posters, manuscripts) under guidance from scientific team members and project manager/s
• Liaise and manage processes with ethics committees, application committees and other relevant stakeholders to support acquisition of data for studies
• Interpret and communicate the results of clinical/observational studies, health economic models (cost-effectiveness and budget impact) and statistical analyses
• Undertake primary and secondary research initiatives including the retrieval and analysis of data, competitive product pipeline information, epidemiology trends, etc. according to needs of the project
• Participates in production of reports, presentations and publications.
• Critically analyzes data (presents results and provides internal data analysis, both qualitative and quantitative) and provides strategic thinking with respect to interpretation of results
• Interact with and foster relationships with existing network of scientific/clinical/payer experts and data providers
• Liaise with other consultants assigned to the project to ensure quality delivery of the project
• Support senior personnel with activities required for business development from time to time
• Align with and work within the framework of SOPs for data governance with respect to projects led

Required Qualifications / Experience

• Minimum of Master’s Degree in Epidemiology, Public Health, Medicine or other related field
• At least 2 years relevant post-graduate work experience preferred

Required Skills

• Professional proficiency in English, written and spoken
• Experience designing/writing protocol for database or other observational studies
• Ability to work both independently and as part of the team
• Ability to effectively prioritize and manage multiple tasks and projects

Other Information

This position can be office based or work-from-home in the UK, EU, Canada or USA.

• Number of Employees Supervised: None
• Percentage of Travel Required: 0-10% travel

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Job Overview

This is a great opportunity for an early career Epidemiologist/Pharmaco-Epidemiologist/Public Health professional to join a team of highly skilled epidemiologists, statisticians, health economists and consultants. The successful candidate will work closely with other senior scientific staff within the company. This position will allow the Senior Analyst/ Epidemiologist to deepen his/her skills by writing protocols for observational studies using a variety of healthcare databases, primary and secondary data collection, as well as providing scientific and other technical input during conception, conduct and delivery of various research projects.

Main Tasks & Responsibilities

• Support RWDS project teams and be accountable to the project manager/director for those projects
• Summarize and synthesize a wide range of medical and statistical information, including disease specific and pharmaceutical product research
• Develop an understanding of Regulatory/HTA requirements for RWE, at least in the European and/or North American context
• Support development of study documents (eg. protocols, analysis plans, reports, posters, manuscripts) under guidance from scientific team members and project manager/s
• Liaise and manage processes with ethics committees, application committees and other relevant stakeholders to support acquisition of data for studies
• Interpret and communicate the results of clinical/observational studies, health economic models (cost-effectiveness and budget impact) and statistical analyses
• Undertake primary and secondary research initiatives including the retrieval and analysis of data, competitive product pipeline information, epidemiology trends, etc. according to needs of the project
• Participates in production of reports, presentations and publications.
• Critically analyzes data (presents results and provides internal data analysis, both qualitative and quantitative) and provides strategic thinking with respect to interpretation of results
• Interact with and foster relationships with existing network of scientific/clinical/payer experts and data providers
• Liaise with other consultants assigned to the project to ensure quality delivery of the project
• Support senior personnel with activities required for business development from time to time
• Align with and work within the framework of SOPs for data governance with respect to projects led

Required Qualifications / Experience

• Minimum of Master’s Degree in Epidemiology, Public Health, Medicine or other related field
• At least 2 years relevant post-graduate work experience preferred

Required Skills

• Professional proficiency in English, written and spoken
• Experience designing/writing protocol for database or other observational studies
• Ability to work both independently and as part of the team
• Ability to effectively prioritize and manage multiple tasks and projects

Other Information

This position can be office based or work-from-home in the UK, EU, Canada or USA.

• Number of Employees Supervised: None
• Percentage of Travel Required: 0-10% travel

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Job Overview

Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process for our clients. The Associate Principal Regulatory Writer (APRW) is a major contributor to document authorship for a variety of documents across different service lines. The APRW will be the project leader and authoring contributor for all types of client engagements, while mentoring others in the knowledge of authoring regulatory documents.

Responsibilities

• Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents
• Lead a project team, and actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents)
• Author documents per client specifications, templates, style guides, and other guidance documents
• Author documents per regulatory authority guidelines and requirements
• Act as client advisor, working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result
• Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work
• Manage budget for a low complexity project, including all contributors (writers, editors)
• Usher documents through the review process, conduct comment resolutions meetings (CRMs) and successfully lead a project team to consensus
• Maintain collaborative, proactive, and effective communication with both client and internal teams
• Lead project-related meetings and teleconferences
• Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements

Education, Experience, Training, And Knowledge

• Bachelor’s degree
• 8+ years of regulatory writing experience as lead author with clinical-related documentation
• Understand regulatory requirements for different phases of development and different regulatory pathways
• Knowledge of global health authority requirements
• Experience in the development of submission-level documents

Skills & Abilities

• Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques
• Strong understanding of the document creation process and of the drug development lifecycle
• Able to synthesize data across multiple data sources and documents to create summary reports
• Expertise to provide subject matter guidance for quality document preparation, document review, accurate comment resolution/incorporation, and document finalization
• Ability to own submission-level sections (e.g., clinical section Module 2.7), taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects
• Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making
• Develops professional relationships with clients as a way to further the business relationship and maintain current industry knowledge
• Ability to identify and institutionalize work practices that are most effective in order to ensure consistency in performance
• Ability to resolve problems that arise, particularly in sensitive or high-pressure situations
• Possesses broad experience and technical expertise across more than one therapy area and integrate this knowledge to deliver business successes and actively transfer this knowledge to strength the skill base across the organization

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Job Overview

This is a great opportunity for an early/mid career Epidemiologist/Pharmaco-Epidemiologist to join a team of highly skilled epidemiologists, statisticians, health economists and consultants. The successful candidate will work closely with other senior scientific staff within the company. This position will allow the successful candidate to get exposed to a variety of study designs and sources of data, including healthcare databases, primary and secondary data collection methods, as well as deepen their skills in designing and conducting observational studies, writing study protocols, providing scientific and other technical input during conception, conduct and delivery of various research projects.

Main Tasks & Responsibilities

• Designs and drafts protocols for a broad range of pharmaco-epidemiological observational studies utilizing real-world databases, primary and secondary data collection methods, including but not limited to clinical databases, administrative/claims databases, disease registries, chart reviews, surveys etc.
• Conducts ad hoc literature reviews on real-world evidence, health economics and related matters.
• Summarizes and synthesizes a wide range of medical and statistical information, including disease specific and pharmaceutical product research
• Provides epidemiological input/research for CRF/eCRF development.
• Follows the scientific aspects of projects, coordinates with the operational, data management and statistical teams, liaise with other consultants assigned to the project to ensure quality delivery of the project
• Participates actively/Supports in the development and conduct of the statistical analysis of studies with statisticians and modelers as required.
• Participates in production of reports, presentations and publications.
• Critically analyzes data (presents results and provides internal data analysis, both qualitative and quantitative) and provides strategic thinking with respect to interpretation of results

• Participates in consulting in epidemiology and drug assessment.
• Participates in bid defense.
• Delivers projects independently and/or produces sub-components of projects of greater complexity, with oversight
• Interacts with clients, as required, with senior staff involvement, as needed.
• Performs necessary administrative functions and additional tasks, as required
• Support senior personnel with activities required for business development from time to time
• Participate in company-sponsored training programs as required to ensure that skills are learned, maintained and focused accordingly

Required Qualifications / Experience

• Minimum of Master’s Degree in Epidemiology, Public Health or other related field
• PhD in Epidemiology preferred
• At least 2 years relevant post-graduate work experience

Required Skills

• Professional proficiency in English, written and spoken
• Experience in designing/writing protocols for observational studies
• Ability to work both independently and as part of the team
• Ability to effectively prioritize and manage multiple tasks and projects

Other Information

• This position can be office based or work-from-home in the UK (preferred), EU (preferred), Canada or USA

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Job Overview

Consultant/Consulting Manager leads the development of client deliverables, performing research and analysis tasks and providing the necessary scientific or strategic insight and interpretation as required for the project. Consultants/Consulting Managers work independently to deliver on client ready deliverables for the contracted projects. Consultants/Consulting Managers coordinate the work of project contributors, and guide the work of contributing analysts and senior analysts in the performance of their assigned tasks necessary to develop final deliverables. Project management and direct, independent client engagement are mainstays of the work of the Consulting Manager. Independent self-directed research, analysis and deliverable production, as well as coherent and clear client presentation and explanations of our research are mainstays of the work of a Technical Consultant.

Your Role And Responsibilities

• Help our clients to bring new and innovative therapies to market, which target unmet medical needs
• Support the market access strategies with scientific research and analyses
• Interact with clients and HTA authorities in Europe
• Independently manage various projects within an interdisciplinary team
• Actively oversee timelines, deliverables, and budgets

Your Education, Experience, And Knowledge

• Bachelor’s degree in relevant field (e.g. health sciences, economics, epidemiology, health policy, etc)
• Advanced degree preferred (e.g. MS, MPH, MBA, MD, PhD)
• Experience with HTA reports and market access; experience with German AMNOG dossiers is a plus
• Good knowledge of the German health system
• Native German speaker and fluency in English

Other Information

• Number of Employees Supervised: 0-2 entry level staff
• Location: Office or Remote-based: Germany

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

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Job Overview

The Business Development Representative (BDR) role will focus on prospect accounts in Europe. In this role you will work closely as part of our Sales Team to prospect a list of accounts which will be provided to you and hand-off to our Enterprise Account Executives and or Global Strategic Account Executives You will maintain a thorough understanding of Certara software and services, industry knowledge including competitive landscape, customer pain points and needs in order to properly position the solution and qualify-in/qualify-out campaign responders. This is a high-energy position as goals are a minimum 100 prospecting activities per day. This role requires an individual who is extremely positive, motivated, enthusiastic, results-driven, pays great attention to detail, is coachable and wants a career in drug development software sales. As a BDR for Certara it will be critical for you to conduct business dealings with prospects in a way that creates a superior customer/prospect experience that will set the stage for a future sale of the Certara software solutions. The ideal candidate for this position will possess a strong sales aptitude, a willingness to perform sales campaigns, and the flexibility to work an alternative schedule to meet the needs of our customers.

Responsibilities

• Meet/exceed Sales Assigned and Sales Qualified Lead goals on a weekly and monthly basis
• Meet/exceed Key Performance Indicator (KPI) metrics on daily/weekly prospecting activities (100 blended activities daily 50 calls / 50 emails)
• Document all activities (phone and email outreach)
• Qualify prospects to the correct agreed upon criteria with the sales organization
• Host Hand-off calls with prospects and the sales team
• Develop and maintain superior relationships with prospects and customers
• Build a strong pipeline to support assigned software quotas to account executives
• Gather market intelligence and relay to management in order to improve offerings and communication for various market needs

Education, Experience, Training, and Knowledge:

• Bachelor’s degree in business or within a science related discipline desirable
• 1-2 years as a lead generation representative, preferably within the pharmaceutical and enterprise B2B SaaS industry
• Attention to detail for capturing all prospect interaction notes into Salesforce
• Experienced in the MS Office suite (Excel/Word/PPT)

Skills & Abilities:

• Excellent verbal and written communication skills
• Strong organizational skills with the ability to multi-task and set priorities
• Ability to work in a high energy team environment
• Must be capable of communicating value propositions for software and services to effectively identify opportunities
• Ability to support bookings pipeline forecasts for account executives
• Must be able to multitask and have strong organizational skills
• Self-motivated professional with ability to work with minimal supervision in a team environment

Values:

• High degree of professionalism: Lives the values of transparency, authenticity, collaboration, respect and accountability
• Has a “Growth Mindset”
• Is a “Continuous Learner”

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Job Overview

Simcyp is looking for experienced C# software developers to join our team in one of the fastest growing and most dynamic fields combining cutting edge drug development and regulatory sciences and software to speed up developing safe and efficacious drugs for patients faster.

This role is a great opportunity for both graduates and experienced developers and all are encouraged to apply, training will be provided.

The Sheffield based Simcyp Division employs over 130 people including over 80 scientists and software developers programing computer simulated models of the human body and the effect pharmaceutical drugs have upon it before going to trial.

Requirements

Essential : Senior

• 4 years of software development experience and a thorough understanding of the software development life cycle from design specification through to testing and evaluation.
• A drive for problem solving and an inquisitive mind.
• Ability to achieve under tight deadlines and thrive in a pressured environment.
• Evidence to support dynamic and self-motivated work.
• Proven ability to work as part of a team on large projects.
• Indications of good communication skills for internal and external contacts.
• Knowledge of WPF, XAML and MVVM architecture.

Essential : Graduate

• A degree in Computer Science or similar with some background/experience of c#
• A drive for problem solving and an inquisitive mind.
• Indications of good communication skills for internal and external contacts.

Key Responsibilities

• Development of desktop applications using WPF/C#.
• Lifecycle product development including design, validation and testing