Global Medical Affairs Services Job at Amaris Consulting (Wavre)

Senior Manager Regulatory Affairs CZ&SK

Senior Manager Regulatory Affairs CZ&SK. Czech Republic - Prague. SALARY RANGE: ...

Location

Czech Republic , Prague

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience
Degree and in-depth regulatory experience and/or related to the affiliate
Depth knowledge of affiliate legislation and regulations relating to medicinal products
English and Czech and/or Slovak language working proficiency
Good negotiation and Influencing skills
Ability to anticipate and prevent potential issues
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Cultural awareness and sensitivity to achieve results across both regional, affiliate and international borders
Ability to manage multiple activities and set priorities
Ability to lead teams and develop effective teams

Job Responsibility

Provides affiliate regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules
Oversee the affiliate and manage a regulatory team to ensure delivery of assigned local and ELMAC Regulatory initiatives
First point of contact for interactions with local regulatory agency(ies)
Ensure that the local Regulatory staff delivers assigned local and ELMAC Regulatory initiatives across the affiliates
Represent Regulatory on the affiliate leadership team
Provide local regulatory input to support development and execution of assigned Regulatory Affairs initiatives and effective interactions with key regulatory agency(ies)
Supervise and oversight for one or more regulatory staff
Manage and liaising with distributors (if applicable)
Translates assigned global, regional and ELMAC Regulatory initiatives into local regulatory objectives where applicable
Acts as senior point of contact for local regulatory advice on commercial and medical activities within the affiliate

Fulltime

Manager, Product Management

This is where creativity meets strategy. As a member of the Baxter Marketing tea...

Location

United States , Milwaukee

Salary:

112000.00 - 154000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in marketing, business, engineering, or equivalent required. MBA preferred
5-7 years of product management/upstream marketing experience in medical devices or related fields. Preferred experience with software based medical devices
Proven go-to-market and product launch excellence
Deep experience with product life cycle management
Strong business acumen and detailed knowledge of upstream/downstream marketing, sales, operations, regulatory, clinical and new product development processes
Experience in highly regulated global healthcare markets
Ability to work autonomously and manage multiple projects simultaneously
Ability to travel approximately 25% of the time. International travel may also be required
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time

Job Responsibility

Drives the go-to-market strategy for portfolio of covered products
Partners with regional commercial marketing teams to support effective product launches and ongoing portfolio management
Develops into a product expert by gaining a deep understanding of customer needs and workflows, as well generates new insights for features/products that grows market share, improves customer experience, and drives growth
Develops into a market expert by understanding market size, addressable segments, pricing, dynamics, and competition while filling gaps through leading market research initiatives
Identifies evidence generation opportunities and supports clinical evidence generation strategy in partnership with medical affairs
Develops, maintains and drives short, medium and long-term product strategy and vision in alignment with overarching business strategy
Works closely with project management to help inform scope and organize program initiatives within an Agile Release Train
Develops, maintains and drives cross functional product roadmap alignment
Collaborates with a cross-functional team including engineering, commercial marketing, service, regulatory, quality, and sourcing to manage the product portfolio, drive profitable growth, and support business goals
Partners with finance and regional teams to develop business cases supporting ongoing and new project investment

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Vice President, Global Head of Drug Safety (DS) & Pharmacovigilance (PV)

Location

Denmark , København og omegn

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

MD and 10+ years of experience in drug safety, pharmacovigilance, risk management, or related roles within the pharmaceutical/biotech industry
Experience as prior Head of DS & PV, with late-stage clinical development and with BLA/NDA/MAA submissions highly preferred
Strong leadership skills with a proven record of building and managing safety teams, including operational and compliance functions
Expertise in global PV regulations, safety surveillance, and risk management strategies
Experience with regulatory authority interactions and safety signal management
Effective communicator with excellent written, verbal, and presentation skills
Proactive self-starter with the ability to thrive in a fast-paced, high-growth environment, balancing multiple priorities while maintaining a strong commitment to ethical standards
Negotiation, influence, and strong project management and interpersonal communication skills that facilitate collaboration across functions and with consultants and CMOs

Job Responsibility

Lead and oversee Hemab DS & PV as well as risk management activities for all programs
Strategically lead the development of Hemab’s DS & PV department, including operations, compliance and medical functions, based on industry best practices
Mentor and develop a high-performing DS & PV team, fostering a culture of safety, compliance, and operational excellence
Participate as a core member of Hemab’s senior leadership team, contributing to overall company strategy
Develop and manage DS & PV budgets, ensuring alignment with corporate objectives
Collaborate cross-functionally with Clinical, Medical Affairs, Regulatory, Quality, Biometrics and other teams to drive safety initiatives
Ensure compliance with global pharmacovigilance regulations (FDA, EMA, ICH, EU GVP, and other relevant agencies)
Manage and oversee internal and external PV resources, including safety functional service providers and consultants
Develop processes for and provide safety medical oversight of safety surveillance and benefit risk assessments, including medical review of ICSRs, signal management activities, safety analyses, benefit risk profile development and monitoring, and risk mitigation strategies
Ensure that aggregate data safety signals are identified promptly and communicated appropriately, including oversight of use of signal detection tools and other sources of product signals

Fulltime

Associate Director / Director, Clinical Quality Assurance

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

University degree in a scientific discipline/life sciences OR equivalent experience in biotech/pharmaceutical industry
Experience in a clinical stage biotech company preferred
10+ years of relevant experience in clinical/GCP quality
Outstanding expertise in GCP R3 and solid understanding of PV regulations
Demonstrated ability to successfully partner cross-functionally
Excellent interpersonal effectiveness, including exceptional communication skills
Advanced computer skills, including experience working in Veeva
Consistent excellent judgement and pragmatic, risk-based decision making skills
Direct experience supporting FDA and other global healthy authority (e.g., EMA, MHRA) inspections and related inspection preparation activities

Job Responsibility

Lead development and execution of enterprise-wide GCP inspection readiness strategies and plans
Conduct inspection risk assessments and coordinate mock inspections, readiness reviews, and remediation activities
Support health authority inspections, including document review, response coordination, and follow-up remediation activities
Serve as the Clinical QA Lead for assigned studies and programs
Provide quality review of protocols, informed consent forms, investigator brochures, CSRs, and regulatory submission documents
Develop and execute program/study-level risk-based audit plan, including investigator site, vendor and internal process audits
Provide quality oversight of CRO and key service providers through qualification, ongoing monitoring, and issue escalation
Provide QA oversight of TMF quality and completeness in collaboration with study teams and TMF group
Support TMF migration activities, as required
Lead quality investigations, root cause analysis, and CAPA development

Fulltime

Group Regulatory Affairs Specialist Class II

At Ontex, we are making everyday life easier across generations. Worldwide our 5...

Location

Germany , Grosspostwitz

Salary:

Not provided

Ontex Peninsular

Expiration Date

Until further notice

Requirements

Master’s degree (university or equal through experience) in science
In-depth knowledge of US and Canada regulations, standards, and guidance documents for medical devices
Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971
Minimum of 3 years experience in Regulatory Affairs for medical devices
Experience in 510k submission
Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
Experience in working with cross-functional teams and building strong relationships across departments
Ability to integrate and demonstrate core values, integrity and accountability throughout the organization and externally
Ability to lead, manage, collaborate and communicate within the organization, with groups engaged in the development of good regulatory practice and policy, and within the regulatory profession

Job Responsibility

Researches and determines requirements for regulatory submissions, approval pathways and compliance activities
Monitor and evaluate the regulatory environment and provide internal advice
Supervises data input activities and provides impact analysis
Identifies the need for new regulatory procedures and SOPs
Identifies requirements for market access and distribution
Evaluates proposed preclinical, clinical and manufacturing documents for regulatory filing
Actively contribute in assessing the impact of new guidance and regulations
Provides regulatory input and technical guidance on global regulatory requirements
Advises stakeholders of regulatory requirements for quality, preclinical and clinical data
Works with cross-functional teams for interactions with regulatory authorities

What we offer

Permanent employment contract in a future-proof company bound by collective agreements
Attractive remuneration and comprehensive social benefits
Holiday and Christmas bonuses
30 days of holiday
Company pension scheme
Corporate benefits and discounts
Exciting and varied working environment

Fulltime

Senior Regulatory Specialist

At GSK, we unite science, technology, and talent to get ahead of disease togethe...

Location

India , Bengaluru

Salary:

144750.00 - 241250.00 PLN / Year

GSK

Expiration Date

Until further notice

Requirements

Bachelor's degree in Chemistry, pharmacy or other related biological science or technical bachelor's degree
English language skills
Knowledge of drug development and manufacturing and supply processes
Knowledge of worldwide CMC post-approval regulatory requirements
Can identify areas for personal professional growth in global regulatory affairs with appropriate support from line manager
Service orientation, customer-focused

Job Responsibility

Responsible for the timely delivery of regulatory activities of multiple projects across dosage forms
Represents New Registration CMC, on Regulatory Networks and Matrix Teams providing guidance to Global Supply Chain (GSC), Commercial, Quality Assurance, 3rd Party Contract Management (via ESQ) and Office of the Chief Medical Officer (OCMO) to produce appropriate components for global regulatory dossiers
Will serve as a mentor/trainer for new team members
May act as a Subject Matter Expert for specific areas for consultation within the team/ department as well as externally outside the department
Independently and confidently executes agreed dossier strategy
Independently manages multiple project simultaneously
assignments will range in complexity but more complex work is expected
Independently completes data assessment to ensure dossier is fit for purpose
Identifies risks associated with submission data and information packages
Escalates issues with line manager that have business impact

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Annual bonus
Eligibility to participate in our share based long term incentive program

Fulltime

Clinical Integration Specialist

As a Clinical Integration Specialist within Resmed’s Medical Affairs Clinical Co...

Location

Malaysia , Kuala Lumpur

Salary:

Not provided

ResMed

Expiration Date

Until further notice

Requirements

Minimum: Bachelor’s degree in science or clinical field
Strong clinical/academic background required
Experience in working with or deep understanding of published clinical research
Experience in literature searches and clinical content, with ability to provide intelligent summary of findings
Independent individual contributor
Proficient at driving projects to completion, at times working remotely with a global team (different time zones involved)
Working knowledge of Microsoft Office (World, Excel, PowerPoint), Outlook, Teams and SharePoint
Strong appetite for technology solutions and interest in GenAI platforms to support process and department improvements

Job Responsibility

Manage marketing material review workflows for Medical Affairs, including review of content for clinical accuracy
Support process management of material review needs for Medical Affairs for both external and internal materials
Support the build of systems and processes to ensure the Clinical Integration team can grow with scale with Resmed’s needs
Understand Resmed’s products and services for clinical application to actively and effectively conduct literature searches as applicable to the role
Learn about software tools for scientific publications in order to assist users in their requests for information, including purchasing articles if required, creating bibliographies and research folders for particular subjects
Update and organise the knowledge management training materials for users to help make training easy and accessible to a range of users
Proactively identify areas of efficiency and/or productivity improvement for knowledge management services to the medical affairs organization
Be prepared to provide regular progress updates to direct manager(s), with opportunity to present project updates to larger Medical Affairs teams
Manage central repository of content created by MA personnel (Claims repository and Sharepoint)
Support communication of Medical Knowledge platforms and updates to broader MA organization

What we offer

Contribute to meaningful work that helps improve patients’ lives and transforms healthcare delivery
Collaborate with diverse, global teams in a dynamic and supportive environment
Access continuous learning and professional growth opportunities

Fulltime

Medical Science Liaison

Location

Italy

Salary:

Not provided

The Muse

Expiration Date

Until further notice

Requirements

Minimum of 3 years of professional experience following the final stage of training, including at least 2 years in clinical practice, research, or healthcare education, preferably within the pharmaceutical or biotech industry
Strong background in infectious diseases, epidemiology, vaccines, or public health
Fluency in Italian and English, with excellent written and verbal communication skills
Strong interpersonal skills with the ability to build and maintain effective professional relationships
Demonstrated ability to manage multiple projects in a field-based environment with strong prioritization and decision-making skills
Proficiency in digital tools and platforms, including MS Office (Word, Excel, PowerPoint) and virtual engagement technologies
Ability to adapt to new technologies and effectively document medical interactions
Willingness to travel extensively across Italy and occasionally internationally (approximately 50-60%)

Job Responsibility

Communicate relevant, accurate, and updated approved medical information to healthcare professionals at local, regional, and national levels, including key opinion leaders, decision-makers, professional associations, payer groups, and public health stakeholders
Provide balanced, scientifically sound responses to unsolicited medical inquiries in full compliance with applicable regulations, policies, and guidelines
Deliver scientific presentations aligned with European and Global Medical Affairs strategies
Build and maintain trusted relationships with external stakeholders and act as a scientific partner to the medical community
Facilitate communication between healthcare professionals, healthcare organizations, and Medical Affairs
Support company-sponsored clinical trials, collaborative research, and investigator-initiated studies in accordance with internal procedures
Contribute to awareness and education initiatives in close collaboration with cross-functional teams
Gather and share customer insights to support the development and refinement of medical strategies
Provide internal scientific expertise, including support for training, medical content development, and review processes
Collaborate closely with Market Access, Sales, Regulatory Affairs, Communications, Customer Services, and Medical Affairs teams locally and across EMEA

What we offer

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short-Term Disability
Long-Term Disability
FSA
HSA
Mental Health Benefits
Adoption Leave

Fulltime

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Global Medical Affairs Services

Job Description

Job Responsibility

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