5 Empregos para Farmácia Comunitária - Portugal
Descrição Do Trabalho
**Job Level:** Senior Director, Drug Development
**Location:** Home-based in Europe
**Job Overview:**
Manages a department or small unit.; Provide leadership and advice on the development of optimum strategies for drug development, product lifecycle management and portfolio management to meet pharmaceutical and biotechnology customer goals (such as strategic leadership of clinical development plans, go/no go decisions, in-licensing, out-licensing, accelerated time to market, etc).; Provide medical, clinical, scientific, regulatory, and product development leadership and consultancy expertise to support strategic business activities and investment opportunities.; Participate in all aspects of Strategic Drug Development and lead the implementation of mission, goals and objectives, development of policies, procedures and standards for the department. ; Provide thought leadership in pharmaceutical product development by preparing publications, white papers, and blogs in areas of expertise and by participating in scientific conferences and webinars, as appropriate.
**Essential Functions:**
+ Evaluate and develop product development strategies for pharmaceutical products (drugs, biologics, advanced therapies) focusing on clinical-commercial convergence that encompasses all phases of development from discovery to market, including preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy.
+ Support engagements with regulatory authorities (e.g., FDA, EMA) on behalf of customers, across the lifecycle of drug development from pre-clinical to licensing, including contribution to briefing documents and other meeting materials, and attendance and contribution to meetings and other interactions.
+ Lead assessments of risk and probability of regulatory success and development of mitigations for candidate pharmaceutical products, including providing regulatory contributions to indication prioritization exercises, development strategy evaluations and gap analyses, due diligence, and similar activities.
+ Support the innovative development of compounds to maximize technical, regulatory, and commercial success, including contribution to the development of Target Product Profiles (TPPs), Clinical Development Plans (CDPs), clinical study designs, synopses, and protocols, as appropriate.
+ Strategic leadership of the development of regulatory submissions, including INDs, marketing/licensing authorizations (NDA/BLA/MAAs), special designations (orphan drugs, pediatrics plans, "fast-track", "break-through" etc.).
+ Ensure high-quality, well-reasoned, objective deliverables (using data-driven design, where available and appropriate) that meet the highest standards of medical, ethical and scientific integrity and conduct.
+ Assume the role of customer senior management as requested, including membership of virtual cross functional drug development teams.
+ Provide drug development expertise to support strategic business activities and investment opportunities.
+ Assist in the development of programs to maximize the organization's growth and profitability.
+ Ensure Customer Satisfaction by working closely with Senior Management, CRO Operations, Therapeutic Units, and other Operations Heads to ensure optimum strategic consultancy to customers.
+ Serve as a key resource and participate in strategic business development activities including presentations to prospective clients, professional meetings or other business development activities for IQVIA Strategic Drug Development.
+ Provide internal and external therapeutic and pharmaceutical development-related educational services in support of all branches of IQVIA business.
+ Attend key scientific meetings/conferences and keep abreast of relevant scientific publications to maintain awareness of current scientific developments and progress in drug development methodology
+ As appropriate, represent IQVIA or the partner in such meetings.
+ Develop and maintain ongoing relationships with pharmaceutical and biotechnology companies, key opinion leaders
+ identify new business opportunities.
+ Compliance with all business office requirements for tracking time and effort.
**Qualifications:**
+ Masters degree or higher or the equivalent combination of education, training and experience.
+ Typically requires 15-20+ years relevant clinical research experience with multi-regional and global focus including significant experience in senior strategic role.
+ Requires broad management and leadership knowledge to lead multiple job areas, the ability to influence others to accept practices and approaches.
+ Expertise in Excel and PowerPoint.
+ Strong strategic thinking, analytical and communication skills and ability to thrive in a culture of achievement.
+ Client-focused and consultative approach for project management - not just an order taker but is able to suggest alternate approaches and provide strategic insights that meet client needs.
+ Demonstrates a strong command of a variety of analytical and market research techniques.
+ Sought out by clients (internal and external) as an analytical expert and, more importantly, as a strategic advisor.
+ Grasps key issues quickly, understands the "big picture", and links market research insights to larger business issues relevant to client needs.
+ Demonstrates excellent written and verbal communication skills and is effective in a variety of presentation settings.
+ Has a strong commitment to quality.
+ Has a proven track record of meeting or exceeding goals.
+ Has broad management knowledge to lead teams and leadership knowledge to lead multiple job areas.
+ Has ability to influence others to accept practices and approaches.
\#LI-Remote
\#LI-HARJINDERBHUMVRA
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
**Location:** Home-based in Europe
**Job Overview:**
Manages a department or small unit.; Provide leadership and advice on the development of optimum strategies for drug development, product lifecycle management and portfolio management to meet pharmaceutical and biotechnology customer goals (such as strategic leadership of clinical development plans, go/no go decisions, in-licensing, out-licensing, accelerated time to market, etc).; Provide medical, clinical, scientific, regulatory, and product development leadership and consultancy expertise to support strategic business activities and investment opportunities.; Participate in all aspects of Strategic Drug Development and lead the implementation of mission, goals and objectives, development of policies, procedures and standards for the department. ; Provide thought leadership in pharmaceutical product development by preparing publications, white papers, and blogs in areas of expertise and by participating in scientific conferences and webinars, as appropriate.
**Essential Functions:**
+ Evaluate and develop product development strategies for pharmaceutical products (drugs, biologics, advanced therapies) focusing on clinical-commercial convergence that encompasses all phases of development from discovery to market, including preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy.
+ Support engagements with regulatory authorities (e.g., FDA, EMA) on behalf of customers, across the lifecycle of drug development from pre-clinical to licensing, including contribution to briefing documents and other meeting materials, and attendance and contribution to meetings and other interactions.
+ Lead assessments of risk and probability of regulatory success and development of mitigations for candidate pharmaceutical products, including providing regulatory contributions to indication prioritization exercises, development strategy evaluations and gap analyses, due diligence, and similar activities.
+ Support the innovative development of compounds to maximize technical, regulatory, and commercial success, including contribution to the development of Target Product Profiles (TPPs), Clinical Development Plans (CDPs), clinical study designs, synopses, and protocols, as appropriate.
+ Strategic leadership of the development of regulatory submissions, including INDs, marketing/licensing authorizations (NDA/BLA/MAAs), special designations (orphan drugs, pediatrics plans, "fast-track", "break-through" etc.).
+ Ensure high-quality, well-reasoned, objective deliverables (using data-driven design, where available and appropriate) that meet the highest standards of medical, ethical and scientific integrity and conduct.
+ Assume the role of customer senior management as requested, including membership of virtual cross functional drug development teams.
+ Provide drug development expertise to support strategic business activities and investment opportunities.
+ Assist in the development of programs to maximize the organization's growth and profitability.
+ Ensure Customer Satisfaction by working closely with Senior Management, CRO Operations, Therapeutic Units, and other Operations Heads to ensure optimum strategic consultancy to customers.
+ Serve as a key resource and participate in strategic business development activities including presentations to prospective clients, professional meetings or other business development activities for IQVIA Strategic Drug Development.
+ Provide internal and external therapeutic and pharmaceutical development-related educational services in support of all branches of IQVIA business.
+ Attend key scientific meetings/conferences and keep abreast of relevant scientific publications to maintain awareness of current scientific developments and progress in drug development methodology
+ As appropriate, represent IQVIA or the partner in such meetings.
+ Develop and maintain ongoing relationships with pharmaceutical and biotechnology companies, key opinion leaders
+ identify new business opportunities.
+ Compliance with all business office requirements for tracking time and effort.
**Qualifications:**
+ Masters degree or higher or the equivalent combination of education, training and experience.
+ Typically requires 15-20+ years relevant clinical research experience with multi-regional and global focus including significant experience in senior strategic role.
+ Requires broad management and leadership knowledge to lead multiple job areas, the ability to influence others to accept practices and approaches.
+ Expertise in Excel and PowerPoint.
+ Strong strategic thinking, analytical and communication skills and ability to thrive in a culture of achievement.
+ Client-focused and consultative approach for project management - not just an order taker but is able to suggest alternate approaches and provide strategic insights that meet client needs.
+ Demonstrates a strong command of a variety of analytical and market research techniques.
+ Sought out by clients (internal and external) as an analytical expert and, more importantly, as a strategic advisor.
+ Grasps key issues quickly, understands the "big picture", and links market research insights to larger business issues relevant to client needs.
+ Demonstrates excellent written and verbal communication skills and is effective in a variety of presentation settings.
+ Has a strong commitment to quality.
+ Has a proven track record of meeting or exceeding goals.
+ Has broad management knowledge to lead teams and leadership knowledge to lead multiple job areas.
+ Has ability to influence others to accept practices and approaches.
\#LI-Remote
\#LI-HARJINDERBHUMVRA
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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0
Sales Representative Pharma - North
Porto
Procter & Gamble
Publicado há 3 dias atrás
Trabalho visualizado
Descrição Do Trabalho
Job Location
LISBON GENERAL OFFICE
Job Description
Have you ever thought of working in the Health Care division of a National Company with an impact of billions of consumers?
If so, Sales at Procter & Gamble is the right place to kick-start your career & leadership development!
As a Sales Representative you will receive meaningful responsibilities from day one. You will be in charge of maintaining and growing long-term partnerships with your customers by continuously proposing solutions and plans that meet shared objectives. In doing so, you will develop a keen understanding of your product categories and markets. Whilst building the plans, you will not only develop your negotiating and sales skills, but also financial & marketing skills, analytical insights, and logistical understanding as you are responsible for your client from A-Z. You will be part of a customer team in which trust, team spirit, real passion for winning and leadership are very important. Aside from your team, your manager will also be able to provide coaching & support wherever needed, which will ensure a nurturing work environment.
Apart from meaningful responsibilities from day 1, exceptional learning opportunities, and an inclusive and international working context, we also offer employees personalized flexibility designed to deliver results and enable employees to grow their careers while meeting personal needs. At P&G, we don't just offer a job, we offer a career with varying assignments and lots of development opportunities, so that we develop our leaders of tomorrow.
As a Sales Representative you will:
+ Assure to follow compliance policy;
+ Assure the sales objective fulfillment and regional market share
+ Implement tactical actions aligned with the sales and marketing strategy which may contribute to accomplishment of the proposed objectives;
+ Report daily activity in the CRM system;
+ Assure implementation of action plan presented by Marketing/Sales adapting it to the region;
+ Ensure the information sharing with direct leadership about market tendencies and competition activities in the region;
+ Participate at the sales and promotional formation;
+ Assure segmentation attributed panel and the implementation of the defined strategy for Segmentation & targeting.
Your main interactions will be internally with the Local Marketing and the rest of the P&G Health team. Externally with Pharmacists and PA, basically and third Parties working for P&G Health.
What does P&G offer you?
+ We will provide you a high-impact managerial position with meaningful work.
+ We love flexibility. You can arrange your work schedule based on your personal needs; you will experience true support for work/life effectiveness and your long-term well-being.
+ You will get a competitive earnings package in line with your qualifications and experience.
About us
We produce globally recognized brands and we grow the best business leaders in the industry. With a portfolio of trusted brands as diverse as ours, it is paramount our leaders are able to lead with courage the vast array of brands, categories and functions. We serve consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always®, Ariel®, Gillette®, Head & Shoulders®, Herbal Essences®, Oral-B®, Pampers®, Pantene®, and more. Our community includes operations in approximately 70 countries worldwide.
Visit to know more. We are an equal opportunity employer and value diversity at our company. We do not discriminate against individuals on the basis of color, gender, age, religion, marital status, disability, or any other legally protected factor.
Job Qualifications
+ A minimum of high school graduate; very highly valued degree on pharmacy.
+ Energy and passion to join a winning team
+ Strong communication skills
+ Good understanding of sales and marketing principles
+ Willing developing sales skills, both strategic and tactical ones
+ Sales knowledge in the area of pharmaceutical Industry and experienced user of sales CRM systems like Salesforce will also be valued
+ Valid driver's license
+ Based in Porto or nearby areas
Job Schedule
Full time
Job Number
R
Job Segmentation
Entry Level
Starting Pay / Salary Range
26.000,00 / year
LISBON GENERAL OFFICE
Job Description
Have you ever thought of working in the Health Care division of a National Company with an impact of billions of consumers?
If so, Sales at Procter & Gamble is the right place to kick-start your career & leadership development!
As a Sales Representative you will receive meaningful responsibilities from day one. You will be in charge of maintaining and growing long-term partnerships with your customers by continuously proposing solutions and plans that meet shared objectives. In doing so, you will develop a keen understanding of your product categories and markets. Whilst building the plans, you will not only develop your negotiating and sales skills, but also financial & marketing skills, analytical insights, and logistical understanding as you are responsible for your client from A-Z. You will be part of a customer team in which trust, team spirit, real passion for winning and leadership are very important. Aside from your team, your manager will also be able to provide coaching & support wherever needed, which will ensure a nurturing work environment.
Apart from meaningful responsibilities from day 1, exceptional learning opportunities, and an inclusive and international working context, we also offer employees personalized flexibility designed to deliver results and enable employees to grow their careers while meeting personal needs. At P&G, we don't just offer a job, we offer a career with varying assignments and lots of development opportunities, so that we develop our leaders of tomorrow.
As a Sales Representative you will:
+ Assure to follow compliance policy;
+ Assure the sales objective fulfillment and regional market share
+ Implement tactical actions aligned with the sales and marketing strategy which may contribute to accomplishment of the proposed objectives;
+ Report daily activity in the CRM system;
+ Assure implementation of action plan presented by Marketing/Sales adapting it to the region;
+ Ensure the information sharing with direct leadership about market tendencies and competition activities in the region;
+ Participate at the sales and promotional formation;
+ Assure segmentation attributed panel and the implementation of the defined strategy for Segmentation & targeting.
Your main interactions will be internally with the Local Marketing and the rest of the P&G Health team. Externally with Pharmacists and PA, basically and third Parties working for P&G Health.
What does P&G offer you?
+ We will provide you a high-impact managerial position with meaningful work.
+ We love flexibility. You can arrange your work schedule based on your personal needs; you will experience true support for work/life effectiveness and your long-term well-being.
+ You will get a competitive earnings package in line with your qualifications and experience.
About us
We produce globally recognized brands and we grow the best business leaders in the industry. With a portfolio of trusted brands as diverse as ours, it is paramount our leaders are able to lead with courage the vast array of brands, categories and functions. We serve consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always®, Ariel®, Gillette®, Head & Shoulders®, Herbal Essences®, Oral-B®, Pampers®, Pantene®, and more. Our community includes operations in approximately 70 countries worldwide.
Visit to know more. We are an equal opportunity employer and value diversity at our company. We do not discriminate against individuals on the basis of color, gender, age, religion, marital status, disability, or any other legally protected factor.
Job Qualifications
+ A minimum of high school graduate; very highly valued degree on pharmacy.
+ Energy and passion to join a winning team
+ Strong communication skills
+ Good understanding of sales and marketing principles
+ Willing developing sales skills, both strategic and tactical ones
+ Sales knowledge in the area of pharmaceutical Industry and experienced user of sales CRM systems like Salesforce will also be valued
+ Valid driver's license
+ Based in Porto or nearby areas
Job Schedule
Full time
Job Number
R
Job Segmentation
Entry Level
Starting Pay / Salary Range
26.000,00 / year
Esse trabalho é adequado ou não?
Candidatar Agora
1
Regulatory Affairs Manager - Regulatory Liaison - FSP
Remoto
ThermoFisher Scientific
Publicado há 2 dias atrás
Trabalho visualizado
Descrição Do Trabalho
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Within our Functional Service Provider (FSP) Solutions business, we partner with leading pharmaceutical, biotechnology, and medical device organizations by providing dedicated regulatory professionals integrated within client teams.
The Regulatory Liaison serves as the primary regulatory representative supporting global clinical development programs. This role acts as the key interface between Regulatory Affairs, Clinical Operations, and other cross-functional stakeholders to ensure timely, compliant regulatory submissions and effective execution of clinical trial activities. The position supports regulatory strategy through operational excellence while ensuring compliance with global and local regulatory requirements.
**Key Responsibilities**
+ Serve as the primary regulatory representative within assigned clinical trial teams.
+ Coordinate and manage regulatory activities supporting global clinical development programs.
+ Prepare, review, compile, and coordinate regulatory submission packages, including:
+ Clinical Trial Applications (CTAs)
+ Substantial Amendments
+ Investigator's Brochures (IBs)
+ Investigational Medicinal Product Dossiers (IMPDs)
+ Country-specific regulatory documentation
+ Ensure submissions are completed accurately and within established timelines in accordance with applicable regional regulations, including EU Clinical Trial Regulation (CTR), ICH-GCP, FDA, MHRA, Health Canada, and other global requirements as applicable.
+ Act as the primary point of contact for regulatory operational activities between Thermo Fisher Scientific, assigned client teams, CRO partners, and regulatory vendors.
+ Track regulatory milestones and submission status while maintaining oversight of regulatory deliverables.
+ Maintain complete and inspection-ready regulatory documentation throughout the clinical trial lifecycle.
+ Ensure compliance with applicable regulatory requirements, client procedures, and Thermo Fisher Scientific quality standards and SOPs.
+ Collaborate with Clinical Operations, Medical Affairs, Regulatory Strategy, Start-Up, Document Management, and other cross-functional teams to support efficient trial execution.
+ Support transparency and disclosure activities where applicable.
+ Identify opportunities for process improvements, operational efficiencies, and regulatory best practices.
+ Provide guidance and mentorship to junior regulatory team members when appropriate.
+ Participate in client governance meetings and contribute to continuous improvement initiatives within the FSP organization.
**Required Skills & Competencies**
**Regulatory Expertise**
+ Strong understanding of global clinical trial regulations, including:
+ EU Clinical Trial Regulation (EU CTR 536/2014)
+ ICH Guidelines
+ FDA regulations
+ Other regional regulatory frameworks
+ Knowledge of clinical trial start-up and lifecycle regulatory requirements.
**Project Management**
+ Strong organizational and planning skills.
+ Ability to manage multiple studies and competing priorities.
+ Demonstrated ability to work under tight timelines while maintaining high-quality deliverables.
+ Excellent attention to detail.
**Analytical Skills**
+ Ability to interpret complex regulatory requirements and translate them into operational activities.
+ Strong problem-solving and critical-thinking abilities.
+ Ability to summarize regulatory information and prepare concise documentation.
**Technical Skills**
+ Experience with:
+ Electronic regulatory submission systems
+ Clinical Trial Management Systems (CTMS)
+ Electronic Document Management Systems (eTMF/EDMS)
+ Microsoft Office Suite
**Communication**
+ Excellent written and verbal communication skills.
+ Ability to build collaborative relationships across global, cross-functional teams.
+ Strong stakeholder management and influencing skills.
+ Fluent English required; additional languages are advantageous.
**Professional Attributes**
+ Highly collaborative with a customer-focused mindset.
+ Demonstrates accountability and ownership.
+ Adaptable within changing project environments.
+ Able to work independently while contributing effectively within matrix organizations.
+ Committed to quality, compliance, and continuous improvement.
**Education & Experience**
**Required**
+ Bachelor's degree in Life Sciences, Pharmacy, Biology, Chemistry, or a related scientific discipline.
+ Advanced degree (Master's or equivalent) preferred.
+ Minimum 5 years of pharmaceutical, biotechnology, CRO, or clinical research experience.
+ Minimum 3 years of experience in Regulatory Affairs supporting clinical trials.
+ Experience preparing and coordinating global regulatory submissions.
+ Experience working within cross-functional global project teams.
**Preferred**
+ Experience supporting Functional Service Provider (FSP) or outsourced regulatory delivery models.
+ Experience working in global, multi-country clinical development programs.
+ Knowledge of Clinical Trial Information System (CTIS).
+ Experience supporting regulatory inspections or audits.
**Why Join Thermo Fisher Scientific?**
At Thermo Fisher Scientific, each one of our 100,000+ extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
As part of our FSP Solutions team, you will:
+ Work alongside leading global pharmaceutical and biotechnology organizations.
+ Build expertise across diverse therapeutic areas and regulatory environments.
+ Benefit from continuous learning and career development opportunities.
+ Be part of an inclusive, collaborative, and innovative culture dedicated to scientific excellence.
Thermo Fisher Scientific is an Equal Opportunity Employer. We value diversity and are committed to creating an inclusive workplace where everyone can thrive
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Within our Functional Service Provider (FSP) Solutions business, we partner with leading pharmaceutical, biotechnology, and medical device organizations by providing dedicated regulatory professionals integrated within client teams.
The Regulatory Liaison serves as the primary regulatory representative supporting global clinical development programs. This role acts as the key interface between Regulatory Affairs, Clinical Operations, and other cross-functional stakeholders to ensure timely, compliant regulatory submissions and effective execution of clinical trial activities. The position supports regulatory strategy through operational excellence while ensuring compliance with global and local regulatory requirements.
**Key Responsibilities**
+ Serve as the primary regulatory representative within assigned clinical trial teams.
+ Coordinate and manage regulatory activities supporting global clinical development programs.
+ Prepare, review, compile, and coordinate regulatory submission packages, including:
+ Clinical Trial Applications (CTAs)
+ Substantial Amendments
+ Investigator's Brochures (IBs)
+ Investigational Medicinal Product Dossiers (IMPDs)
+ Country-specific regulatory documentation
+ Ensure submissions are completed accurately and within established timelines in accordance with applicable regional regulations, including EU Clinical Trial Regulation (CTR), ICH-GCP, FDA, MHRA, Health Canada, and other global requirements as applicable.
+ Act as the primary point of contact for regulatory operational activities between Thermo Fisher Scientific, assigned client teams, CRO partners, and regulatory vendors.
+ Track regulatory milestones and submission status while maintaining oversight of regulatory deliverables.
+ Maintain complete and inspection-ready regulatory documentation throughout the clinical trial lifecycle.
+ Ensure compliance with applicable regulatory requirements, client procedures, and Thermo Fisher Scientific quality standards and SOPs.
+ Collaborate with Clinical Operations, Medical Affairs, Regulatory Strategy, Start-Up, Document Management, and other cross-functional teams to support efficient trial execution.
+ Support transparency and disclosure activities where applicable.
+ Identify opportunities for process improvements, operational efficiencies, and regulatory best practices.
+ Provide guidance and mentorship to junior regulatory team members when appropriate.
+ Participate in client governance meetings and contribute to continuous improvement initiatives within the FSP organization.
**Required Skills & Competencies**
**Regulatory Expertise**
+ Strong understanding of global clinical trial regulations, including:
+ EU Clinical Trial Regulation (EU CTR 536/2014)
+ ICH Guidelines
+ FDA regulations
+ Other regional regulatory frameworks
+ Knowledge of clinical trial start-up and lifecycle regulatory requirements.
**Project Management**
+ Strong organizational and planning skills.
+ Ability to manage multiple studies and competing priorities.
+ Demonstrated ability to work under tight timelines while maintaining high-quality deliverables.
+ Excellent attention to detail.
**Analytical Skills**
+ Ability to interpret complex regulatory requirements and translate them into operational activities.
+ Strong problem-solving and critical-thinking abilities.
+ Ability to summarize regulatory information and prepare concise documentation.
**Technical Skills**
+ Experience with:
+ Electronic regulatory submission systems
+ Clinical Trial Management Systems (CTMS)
+ Electronic Document Management Systems (eTMF/EDMS)
+ Microsoft Office Suite
**Communication**
+ Excellent written and verbal communication skills.
+ Ability to build collaborative relationships across global, cross-functional teams.
+ Strong stakeholder management and influencing skills.
+ Fluent English required; additional languages are advantageous.
**Professional Attributes**
+ Highly collaborative with a customer-focused mindset.
+ Demonstrates accountability and ownership.
+ Adaptable within changing project environments.
+ Able to work independently while contributing effectively within matrix organizations.
+ Committed to quality, compliance, and continuous improvement.
**Education & Experience**
**Required**
+ Bachelor's degree in Life Sciences, Pharmacy, Biology, Chemistry, or a related scientific discipline.
+ Advanced degree (Master's or equivalent) preferred.
+ Minimum 5 years of pharmaceutical, biotechnology, CRO, or clinical research experience.
+ Minimum 3 years of experience in Regulatory Affairs supporting clinical trials.
+ Experience preparing and coordinating global regulatory submissions.
+ Experience working within cross-functional global project teams.
**Preferred**
+ Experience supporting Functional Service Provider (FSP) or outsourced regulatory delivery models.
+ Experience working in global, multi-country clinical development programs.
+ Knowledge of Clinical Trial Information System (CTIS).
+ Experience supporting regulatory inspections or audits.
**Why Join Thermo Fisher Scientific?**
At Thermo Fisher Scientific, each one of our 100,000+ extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
As part of our FSP Solutions team, you will:
+ Work alongside leading global pharmaceutical and biotechnology organizations.
+ Build expertise across diverse therapeutic areas and regulatory environments.
+ Benefit from continuous learning and career development opportunities.
+ Be part of an inclusive, collaborative, and innovative culture dedicated to scientific excellence.
Thermo Fisher Scientific is an Equal Opportunity Employer. We value diversity and are committed to creating an inclusive workplace where everyone can thrive
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Esse trabalho é adequado ou não?
Candidatar Agora
2
Gynaecology Surgical Solutions EMEA Scientific Affairs Manager
Remoto
Hologic
Hoje
Trabalho visualizado
Descrição Do Trabalho
Gynaecology Surgical Solutions EMEA Scientific Affairs Manager
United Kingdom
Italy
Portugal
Netherlands
France
Belgium
Spain
Germany
At Hologic, we are dedicated to enabling healthier lives everywhere, every day, by advancing women's health through innovative gynecological solutions. Guided by The Science of Sure, we strive to provide clinicians with precise, reliable technologies that support minimally invasive management of abnormal uterine bleeding, fibroids and other benign gynecological conditions. Our Gynecological Surgical Solutions portfolio, including NovaSure endometrial ablation, MyoSure tissue removal systems and related hysteroscopic technologies, is designed to enhance clinical outcomes, reduce the need for more invasive procedures and improve quality of life for women around the world.
Hologic is now looking for an International Scientific Affairs Manager focused on our Gynecological Surgical Solutions portfolio. In this role, you will act as a scientific and clinical expert for the product range, driving the generation, interpretation and communication of high-quality evidence to support safe, effective and evidence-based use of our technologies across international markets. As a key ambassador for Hologic, you will engage with international KOLs, support advisory boards and investigator-initiated research, and help position Hologic's gynecological surgical solutions within clinical guidelines and standard of care, ultimately contributing to the advancement of women's health worldwide.
**What To Expect**
+ A strategically important, highly visible role at the interface of science, clinical practice and business for a market-leading women's health company
+ Close collaboration with international KOLs, professional societies and leading centres in gynecological surgery
+ Responsibility for driving and supporting evidence generation activities, including clinical studies, real-world data initiatives and health-economic projects
+ Involvement in the development and delivery of impactful medical education programs, symposia and training for healthcare professionals
+ A dynamic, international environment with frequent cross-functional interaction and the opportunity to influence global and regional strategy for the GSS portfolio
+ Regular travel, approximately 40%, to attend scientific congresses, educational events, internal meetings and site visits across Europe and beyond
**What We Expect**
+ Proven experience in Scientific or Medical Affairs within the medical device industry, ideally with a focus on surgical devices
+ Experience in gynaecology or women's health is highly desirable
+ Demonstrated experience working across multiple countries or regions, with an understanding of how clinical practice, regulation and reimbursement differ between markets
+ Ability to engage confidently and credibly with healthcare professionals, KOLs and payer-facing stakeholders on scientific, clinical and health-economic topics
+ Strong analytical skills to interpret data and develop clear, balanced scientific narratives that support both clinical practice and Market Access needs
+ A structured, organised approach to managing multiple projects and deadlines across markets
+ Effective collaboration with colleagues from Medical Affairs, Clinical, Marketing, Regulatory, Commercial and Market Access teams
**Why Hologic?**
+ You will contribute to a clear, meaningful purpose: improving women's health through better gynaecological care and broader access to minimally invasive solutions
+ You will work with innovative, procedure-focused technologies supported by a strong and growing clinical and health-economic evidence base
+ You will join a company that places science, data, value demonstration and clinical partnership at the centre of its strategy
+ You will be part of a collaborative culture that values initiative, openness and continuous learning
Salary: UK £64,000-£95,000, Belgium 75,000-125,000, Spain 54,000-100,000, France 70,000-120,000, Germany 83,000-145,000, Italy 60,000-120,000 gross per year. The final offer will depend on experience, skills, and alignment with internal pay structures. In addition, we offer a comprehensive benefits package including pension and insurances.
**Apply today!**
**\#LI-AB1 #LI-Remote**
United Kingdom
Italy
Portugal
Netherlands
France
Belgium
Spain
Germany
At Hologic, we are dedicated to enabling healthier lives everywhere, every day, by advancing women's health through innovative gynecological solutions. Guided by The Science of Sure, we strive to provide clinicians with precise, reliable technologies that support minimally invasive management of abnormal uterine bleeding, fibroids and other benign gynecological conditions. Our Gynecological Surgical Solutions portfolio, including NovaSure endometrial ablation, MyoSure tissue removal systems and related hysteroscopic technologies, is designed to enhance clinical outcomes, reduce the need for more invasive procedures and improve quality of life for women around the world.
Hologic is now looking for an International Scientific Affairs Manager focused on our Gynecological Surgical Solutions portfolio. In this role, you will act as a scientific and clinical expert for the product range, driving the generation, interpretation and communication of high-quality evidence to support safe, effective and evidence-based use of our technologies across international markets. As a key ambassador for Hologic, you will engage with international KOLs, support advisory boards and investigator-initiated research, and help position Hologic's gynecological surgical solutions within clinical guidelines and standard of care, ultimately contributing to the advancement of women's health worldwide.
**What To Expect**
+ A strategically important, highly visible role at the interface of science, clinical practice and business for a market-leading women's health company
+ Close collaboration with international KOLs, professional societies and leading centres in gynecological surgery
+ Responsibility for driving and supporting evidence generation activities, including clinical studies, real-world data initiatives and health-economic projects
+ Involvement in the development and delivery of impactful medical education programs, symposia and training for healthcare professionals
+ A dynamic, international environment with frequent cross-functional interaction and the opportunity to influence global and regional strategy for the GSS portfolio
+ Regular travel, approximately 40%, to attend scientific congresses, educational events, internal meetings and site visits across Europe and beyond
**What We Expect**
+ Proven experience in Scientific or Medical Affairs within the medical device industry, ideally with a focus on surgical devices
+ Experience in gynaecology or women's health is highly desirable
+ Demonstrated experience working across multiple countries or regions, with an understanding of how clinical practice, regulation and reimbursement differ between markets
+ Ability to engage confidently and credibly with healthcare professionals, KOLs and payer-facing stakeholders on scientific, clinical and health-economic topics
+ Strong analytical skills to interpret data and develop clear, balanced scientific narratives that support both clinical practice and Market Access needs
+ A structured, organised approach to managing multiple projects and deadlines across markets
+ Effective collaboration with colleagues from Medical Affairs, Clinical, Marketing, Regulatory, Commercial and Market Access teams
**Why Hologic?**
+ You will contribute to a clear, meaningful purpose: improving women's health through better gynaecological care and broader access to minimally invasive solutions
+ You will work with innovative, procedure-focused technologies supported by a strong and growing clinical and health-economic evidence base
+ You will join a company that places science, data, value demonstration and clinical partnership at the centre of its strategy
+ You will be part of a collaborative culture that values initiative, openness and continuous learning
Salary: UK £64,000-£95,000, Belgium 75,000-125,000, Spain 54,000-100,000, France 70,000-120,000, Germany 83,000-145,000, Italy 60,000-120,000 gross per year. The final offer will depend on experience, skills, and alignment with internal pay structures. In addition, we offer a comprehensive benefits package including pension and insurances.
**Apply today!**
**\#LI-AB1 #LI-Remote**
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3
Manager, PV (Medical Project Coordinator Team), EMEA
Remoto
ThermoFisher Scientific
Publicado há 2 dias atrás
Trabalho visualizado
Descrição Do Trabalho
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join us as Manager PVG - And lead the efforts in managing and optimizing drug safety operations to ensure the highest standards of patient safety and regulatory compliance in clinical trials.
What You'll Do:
- Manage multiple aspects of projects, both local and globally, such as contractual, procedural and regulatory requirements.
- Maintain good communications with other functional groups concerning program and company issues. Collaborating with other employees in problem
solving and systems improvement.
- Review regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
- Maintain a basic medical understanding of applicable therapeutic areas and disease states. May participate in on-call duties for specific projects and ensure 24-hr coverage for intake of cases from investigative sites.
- Provide plans and accurate forecasts for all projects.
- Serve as a resource for other departmental managers and lead departmental initiatives.
- Prepare and present proposals.
- Manage staff of experienced professionals, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approve courses of action on salary administration, hiring, corrective action, and terminations. Review and approve time records, expense reports, requests for leave, and overtime.
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification to include 3+ years of safety experience
- Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- 1+ year of leadership responsibility
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.
- Working knowledge of the global regulatory requirements and the importance of and compliance with procedural documents
- Strong knowledge of relevant therapeutic areas as required for processing AEs
- General knowledge of pathophysiology and the disease process
- Time management and project management skills
- Proficiency in Microsoft Office products and safety databases
- Good command of English and ability to translate information into local language where required
- Excellent oral and written communication skills
- Strong attention to detail and accuracy
- Strong critical thinking, problem solving and decision-making skills
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment
- Daily exposure to high pressure and intense concentration
- Daily interactions with clients/associates
- Long, varied hours on occasion
- Travel required occasionally domestic and/or international
Physical Requirements:
- Frequently vertical and /or stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Frequent bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate moderately complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacting with others, relates sensitive information to diverse groups.
- Ability to apply basic principles to solve conceptual issues.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience - and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthrough.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join us as Manager PVG - And lead the efforts in managing and optimizing drug safety operations to ensure the highest standards of patient safety and regulatory compliance in clinical trials.
What You'll Do:
- Manage multiple aspects of projects, both local and globally, such as contractual, procedural and regulatory requirements.
- Maintain good communications with other functional groups concerning program and company issues. Collaborating with other employees in problem
solving and systems improvement.
- Review regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
- Maintain a basic medical understanding of applicable therapeutic areas and disease states. May participate in on-call duties for specific projects and ensure 24-hr coverage for intake of cases from investigative sites.
- Provide plans and accurate forecasts for all projects.
- Serve as a resource for other departmental managers and lead departmental initiatives.
- Prepare and present proposals.
- Manage staff of experienced professionals, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approve courses of action on salary administration, hiring, corrective action, and terminations. Review and approve time records, expense reports, requests for leave, and overtime.
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification to include 3+ years of safety experience
- Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- 1+ year of leadership responsibility
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.
- Working knowledge of the global regulatory requirements and the importance of and compliance with procedural documents
- Strong knowledge of relevant therapeutic areas as required for processing AEs
- General knowledge of pathophysiology and the disease process
- Time management and project management skills
- Proficiency in Microsoft Office products and safety databases
- Good command of English and ability to translate information into local language where required
- Excellent oral and written communication skills
- Strong attention to detail and accuracy
- Strong critical thinking, problem solving and decision-making skills
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment
- Daily exposure to high pressure and intense concentration
- Daily interactions with clients/associates
- Long, varied hours on occasion
- Travel required occasionally domestic and/or international
Physical Requirements:
- Frequently vertical and /or stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Frequent bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate moderately complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacting with others, relates sensitive information to diverse groups.
- Ability to apply basic principles to solve conceptual issues.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience - and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthrough.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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4