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Job Description
Major Activities Major activities include, but are not limited to:
New MA applications for assigned products:
Performs timely and correct submission and approval of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing and external affairs departments, GRA/RAI on sub-regional, regional and global level, as well as with local regulatory authorities as appropriate, depending on procedure type. Coordinates and implements early access programs with the Agency. Tracks process and manages answers to objections from the Agency on products registration and major new indications, involving negotiations to achieve best conditions.
Designs and implements local action plans for new products, involving selection and regulatory training of external experts and closely interacting with the Agency and Advisory Committee members, with continuous interface with RAI, EEMEA regional liaisons.
Maintenance of licenses for assigned products:
Ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the agreed timeframes and communicates approvals to stakeholders through the correct processes.
For major indications, designs and implements local action plans as above mentioned for new MA applications.
Compliance:
For assigned products, ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to the company and local standards and Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.
Ensures that all internal customers receive relevant information with regard to the regulatory status of the assigned products. Ensures the correct and proper utilization of AMS Blue to generate mockup artwork and to implement revisions to artwork.
Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
Ensures that files and archives related to Regulatory are kept updated and complete.
Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
Labeling and artwork:
Ensures high quality translations and QRD check of Summary of Product Characteristics and Patient Package Leaflets including linguistic check of these documents.
Ensures availability of packaging material, including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.
Cross-functional activities:
Obtains early information about new studies to be able to advice on Clinical Trial Applications and study planning as appropriate to the local GCTO group responsible for Clinical Trials.
Ensures adequate support to other functions to enable compliance in areas related to regulatory, such as PSUR submissions and review of promotional material.
Provides regulatory guidance and support to the license companies/joint venture/co-marketing partners as appropriate.
Secures timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions.
Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.
Participates, provides active input and lead if the case the local Medical Governance.
Regulatory Policy/Environment:
Keeps abreast of local and international laws.
Through active participation in the regulatory work of the local Pharmaceutical Industry Association the incumbent seeks alignment of industry position with the company's interests.
Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization and other stakeholders, and in concurrence with the Global & EEMEA Regulatory Policy lead.
Participates in internal registration managers' meetings at sub-regional and regional level and EEMEA regulatory workgroups on selected issues.
For new regulations, identifies and tracks changes/trends that might impact the company's business.
Participates in task forces of Pharmaceutical Industry/Agency.
Manage direct report, as applicable:
Sets up priorities, organizes, oversees and monitors direct report's activities, towards division's and country's objectives achievement in compliance with policies and standards.
Ensures that direct reports are trained for their proper use of internal regulatory systems.
Through attendance to courses/workshops ensures that staff is appropriated updated on new legislations, requirements on Regulatory.
Manages, coaches, and develops talent. Maintains a scientific knowledge and expertise for therapeutic areas of the company.
Fosters a positive team spirit of the staff.
Qualifications and Experience Required:
Minimum BPharm or other life science or equivalent.
A minimum of 5-10 years' Pharmaceutical Industry/Medical or Biotechnology experience.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
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.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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Job Description
General Summary:
The Training Associate Director is responsible for supporting the oversight of all Training related activities within the Global Regulatory Affairs organization. This role will work to create, curate, and deliver top notch learning experiences including both technical and professional development for the team. The Training Associate Director will report directly to the Senior Director of Regulatory Compliance and Business Operations.
Key Duties and Responsibilities:
Knowledge and Skills:
Education and Experience:
We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:
1. Hybrid and work remotely up to two days per week; or select
2. On-Site and work 5 days per week with ad hoc flexibility.
#LI-EE1 #LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
Official account of Jobstore.
Job Description
General Summary:
The Director, Regulatory Affairs Resource Management leads the overall management of the Global Regulatory financials and resource plans, working in close collaboration with finance and HR. This position will report directly to the Senior Director of Regulatory Compliance and Business Operations.
Key Duties and Responsibilities:
Knowledge and Skills:
Education and Experience:
We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:
1. Hybrid and work remotely up to two days per week; or select
2. On-Site and work 5 days per week with ad hoc flexibility.
#LI-EE1 #LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
Official account of Jobstore.
Job Description
Our Medical Affairs team advances medical science and patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of our products is developed and realized.
Role Summary:
The Executive Director, Scientific Affairs (EDSA) maximizes meaningful bi-directional scientific exchange with the worldwide clinical and academic community to positively impact Research and Development (R&D) strategy for new medicines and to improve outcomes for patients.
The EDSA leads a large investigator-initiated studies program in partnership with late-stage development teams in Medical Affairs while also supporting early-stage development teams. The role also partners with Medical Affairs leadership to develop the global Value Evidence and Medical (VEAM) Planning strategy across designated therapeutic areas.
The EDSA has a key role at major Congresses, including, but not limited to, facilitating daily debriefs, engaging with Scientific Leaders (SLs), and producing comprehensive Congress summary reports.
Primary Responsibilities:
Leads our Company’s Investigator Initiated Studies program for our cardiovascular portfolio (Atherosclerosis, Atherothrombosis, Heart Failure) ensuring scientific rigor
Provides subject matter expertise for Product Development and Publications teams and facilitates cross-functional communication and collaboration in pursuit of our company’s R&D strategy
Leads R&D activities and synthesizes competitive intelligence relevant to our company’s R&D strategy at key scientific congresses
Leads our Company’s global scientific input forums to gain external scientific/ clinical insights in support of our Company’s R&D strategy
Sustains our Company’s scientific credibility and fosters and develops relationships with global leaders, major academic medical centers, and key professional societies and organizations through relevant bi-directional scientific exchange
Guides development of consistent and accurate scientific content in support of our global field-based Medical Affairs teams and advises and supports them in providing global perspective in their interactions with external stakeholders
Maintains personal expertise in the assigned disease area science in the context of advancing clinical and treatment paradigms
Education:
Medical Degree (e.g., MD or MD equivalent degree)
Additional higher Scientific Degree (e.g., PhD) preferred
Required Experience and Skills:
8+ years of clinical leadership experience after completing postgraduate training in cardiovascular
Significant research experience as lead clinical investigator, specifically experience with investigator-initiated studies, concept assessment, and protocol review
Proven ability to work in a complex matrix environment and effectively operate in a team-oriented structure
Advanced facilitation and consultative skills
Ability to effectively interact with internal and external stakeholders and to positively influence decision making at a senior level
Excellent interpersonal communication (written and verbal)
Results-oriented project management skills
Preferred Experience and Skills:
Impactful publication record in a relevant therapeutic area, with international recognition
Pharmaceutical industry experience
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:
$259,440.00 - $408,300.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aOfficial account of Jobstore.
Job Description
The Identification of Medicinal Products (IDMP) Business Analyst will play a key role in the management and leadership of the European implementation of the ISO Identification IDMP’s standard in our Company. You will be part of a team progressing the strategic, project and operational activities in relation with regulatory data submitted to European authorities, including IDMP/SPOR (European implementation of ISO IDMP), DADI (replacement of the PDF electronic Application Form) and knowledge of XEVMPD ((Extended EudraVigilance Medicinal Product Dictionary, or Article 57) is necessary to properly transition to IDMP from strategic and tactical perspectives. You are also expected to cover several non-EU related topics.
Primary Activities include but are not limited to:
Qualifications, Skills & Experience:
Desired Experience and Skills
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
IMPORTANT APPLICATION INSTRUCTIONS:
Note: If you have an expansive CV, we recommend that you apply manually and only include the positions you have held in the last ten (10) years. You will then be able to attach your Resume/CV, as well as all other supporting documentation in the "My Experience" section of your application.
Job Description
SUMMARY:
Reporting to the Director of Government Relations and Community Affairs, the Assistant Director assists with day-to-day management and coordination of activities and relationships with local, state, and federal legislative and agency officials, University staff, and other community stakeholders with a focus on local community engagement.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Provide support and direction to the varied University efforts involving community engagement, including, but not limited to the Center for Community Engagement and yet to be established units of the University that focus on forging University-Community partnerships and projects.
Serve as a thought leader with respect to program staff around methodologies and best practices in authentic and effective community engagement.
In conjunction with the Director of Government Relations, develop and maintain strong, authentic relationships with municipal, county, and state level community-based organizations as well as local and county elected officials and establish relationship strategic plan, goals, and expectations.
Understand and effectively communicate the University’s mission, vision, core values and strategic direction to external groups, including key stakeholders and intermediaries.
Work with community action groups to design and deliver projects that help to improve local health and wellbeing.
Build relationships, as well as connect people with skills, tools and networks.
Manage high-priority projects designed to achieve the University's mission and strategic vision; build and maintain successful working relationships and coordinate with a wide range of offices, staff, and stakeholders, internal and external to the University.
Gather, investigate, research, analyze, and/or study information affecting University-wide, intradepartmental, or interdepartmental operations; participate in institutional planning, policy development, and problem resolution as a member of senior staff.
Anticipate, identify and troubleshoot issues of concern or significance; exercise discretion to provide timely information and necessary updates across multiple stakeholders.
Research, write, edit and/or coordinate preparation of special reports, briefings and presentations; conceive, craft, and edit messages, letters and other communications on behalf of executive leadership and the Director of Government Relations and Community Affairs.
Coordinate and/or oversee the scheduling of strategic events, meetings and other requests to balance and address key institutional objectives.
Support and sustain a culture of service, professionalism and continuous improvement in the Office of the President.
Perform other duties as assigned.
Management retains the right to add or change job duties at any time.
QUALIFICATIONS:
REQUIRED:
Bachelor's degree from an accredited college or university.
Minimum of three years of professional experience in government relations.
Exceptional interpersonal skills and the ability to interact and work effectively with administrators, academic leadership, faculty, students, community leadership, public officials, funding agencies, and members of the community at large.
Demonstrated ability to maintain confidentiality.
Superior research, writing, and oral communication.
Strategic planning skills.
PREFERRED:
Master’s degree in political science, public administration, or related field.
Ability to identify, analyze and address a wide variety of issues and problems in a high-intensity environment.
Knowledge of the goals, objectives, structure and operations of a major public university.
Ability to gather data, compile information, and prepare reports.
Ability to perform complex tasks and to prioritize multiple projects.
PROCEDURE FOR CANDIDACY
Applicants should include a resume and cover letter describing how their background, skills and education match the needs of the University. When applying, please take a moment to carefully read and follow the steps in the application instruction.
Department
Government Relations and Community AffairsPosition Type
AdministrativeContact Information:
For questions or concerns, please contact Human Resources' Workday Recruiting Support at 973-655-5000 (Option 2), or email talent@montclair.edu.
EEO/AA Statement
Montclair State University is an Equal Opportunity/Affirmative Action institution with a strong commitment to diversity.
Additional information can be found on the website at
www.montclair.edu/human-resources/about-us/eo-aa-and-diversity/
Title IX and 34 C.F.R. 106 Policy
Montclair State is required by Title IX and 34 C.F.R. 106 not to discriminate on the basis of sex or gender, and does not discriminate on the basis of sex or gender in the operation of education programs and activities. The requirement to not discriminate on the basis of sex or gender in the operation of education programs and activities extends to admission and employment. For further details, please visit: https://www.montclair.edu/human-resources/job-seekers/
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Job Description
Role Summary:
The Global Senior Director Medical Affairs (GDMA) is responsible for driving execution of scientific & medical affairs plans for their assigned Therapy Areas (TA) in key countries and regions. They are impactful members of Product Development Team sub-teams and Global Human Health commercialization teams. They collaborate with Global Commercial, Center of Real-World Evidence (CORE), Policy and Market Access to address opportunities in key countries. They engage with their network of scientific leaders and decision makers. This is a headquarters-based position in Our Company Research Laboratories Global Medical and Scientific Affairs (Research & Development (R&D) GMSA).
Responsibilities and Primary Activities:
Drives execution of the annual scientific & medical plan with medical affairs colleagues from key countries and regions
Serves as an impactful member of Product Development Team sub-teams (Clinical, Value Evidence, Commercial, Publications and Label) and Global Human Health commercialization teams
Contributes to the development of a single global scientific communications platform
Consolidates actionable medical insights from countries and regions
Engages with a network of international scientific leaders and other key stakeholders (therapeutic guideline committees, payers, public groups, government officials, medical societies) about Our Company’s emerging science
Organizes global expert input events (advisory boards and expert input forums) to answer Our Company’s questions about how to develop and implement new medicines or vaccines
Aligns plans and activities with Global Human Health (commercial) executive directors
Organizes global symposia and educational meetings
Supports key countries with the development of local data generation study concepts and protocols
Reviews Investigator-Initiated Study proposals from key countries prior to headquarters submission (ex-USA)
Manages programs (patient support, educational or risk management) to support appropriate and safe utilization of Our Company medicines or vaccines
Required Qualifications, Skills & Experience:
Minimum:
M.D., Ph.D. or Pharm.D. (M.D. preferred) and recognized medical expertise
At least 3 years regional medical affairs experience (e.g., Regional Director Medical Affairs) with proven track record of contribution to medical affairs strategies
Minimum of 2 years Oncology experience.
Experience in country/region medical affairs or clinical development
Strong prioritization and decision-making skills
Ability to effectively collaborate with partners across divisions in a matrix environment
Excellent interpersonal, analytical, communication skills (written and oral) in addition to results-oriented project management skills
Preferred:
Customer expertise, especially of scientific leadership and other key stakeholders (payers, public groups, government officials, medical professional organizations) in the assigned therapeutic area
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:
$200,200.00 - $315,100.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
50%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aOfficial account of Jobstore.
Job Description
General Summary:
The Vendor Management Associate Director oversees all vendor management activities for Global Regulatory Affairs, including vendor governance, vendor relationship management, performance management, and new vendor selection process. This role will serve as the key interface between Regulatory functional leaders and departmental vendors.
Key Duties and Responsibilities:
Knowledge and Skills:
Education and Experience:
We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:
1. Hybrid and work remotely up to two days per week; or select
2. On-Site and work 5 days per week with ad hoc flexibility.
#LI-EE1 #LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
Official account of Jobstore.
The Role:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Moderna is solidifying its footprint in Basel, the vibrant hub of pharmaceutical innovation in Switzerland, to further our mission of delivering the greatest possible impact to people through mRNA medicines. As we grow our international operations and commercial activities in Basel, we invite global talents to join us in this exciting journey of transforming medicine and impacting lives worldwide.
An exciting opportunity has arisen for an Associate Director, CMC Regulatory Affairs-International, to join our team based in Basel. This pivotal role will focus on preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, governing CMC submissions, and providing regulatory compliance support for the development of global products. The successful candidate will lead and support all regulatory activities, ensuring the delivery of high-quality CMC sections of regulatory documentation. This role demands a dynamic individual capable of managing multiple projects in a fast and results-oriented environment, dedicated to bringing a new generation of transformative medicines to patients.
Here’s What You’ll Do:
Developing and implementing effective CMC regulatory strategies for international submissions (e.g., IND/CTA/BLA/MAA) and identifying regulatory risks.
Providing guidance on regulatory CMC aspects of product development projects.
Reviewing documents for submission readiness, ensuring conformity to health authority guidelines.
Leading Regulatory CMC discussions and interactions with health authorities to facilitate the review and approval of submissions.
Developing regulatory processes and procedures to support the CMC components of regulatory submissions.
Your responsibilities will also include:
Supporting the creation and maintenance of CMC submission templates.
Providing CMC regulatory guidance to manufacturing and quality teams; evaluating CMC change controls.
Offering interpretations of regulatory guidance documents, regulations, and directives, advising on their applicability and impact on internal programs.
Leading oversight of multiple programs in various therapeutic areas (vaccines, oncology, and/or rare diseases).
The key Moderna Mindsets you’ll need to succeed in the role:
Pursue options in parallel: This role requires a strategic thinker who can explore multiple avenues simultaneously to ensure the most efficient and effective regulatory strategies.
Act with urgency: Given the fast-paced and result-oriented environment, acting swiftly and decisively is crucial to meet deadlines and deliver transformative medicines to patients.
Here’s What You’ll Bring to the Table:
BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable
10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
8+ years of experience in Biologics focused Regulatory CMC
Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases)
Strong knowledge of current EU and ROW regulations
Strong knowledge of Cgmp
Strong experience with CTD format and content regulatory filings
Exceptional written and oral communication
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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Bridge building with key influencers, decision makers, policy makers and KOL´s , including but not limited to, Executive & Legislative branches of power, NGO´s, Federal, State and local authorities, political parties, in order to position Company´s agenda. Participation and leading role within trade and/or industry associations. Deep understanding of political & economical framework to bring opportunities to the business, ensure freedom to operate and anticipate any risk.
Interaction with key influencers, decision makers, policy makers, and KOL´s; participation in trade/industry associations
Ability to act as solely member of the team and work through influencing others
Ability to influence peers, colleagues from Regulatory & Medical Affairs and to interact with teams and GM´s from all the units.
Holistic approach and network
Bachelor degree in Law, Economics, International Relations, Political Sciences
Master´s degree related to public policy is a plus
+10 years of experience on the interaction with government, government officials, policy makers, influencers and KOL´s.
Experience in health sector is highly desirable and experience within public sector is a plus
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
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To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts.
Job Category
Customer SuccessJob Details
About Salesforce
We’re Salesforce, the Customer Company, inspiring the future of business with AI+ Data +CRM. Leading with our core values, we help companies across every industry blaze new trails and connect with customers in a whole new way. And, we empower you to be a Trailblazer, too — driving your performance and career growth, charting new paths, and improving the state of the world. If you believe in business as the greatest platform for change and in companies doing well and doing good – you’ve come to the right place.
Who We Are
We’re Salesforce, the Customer Company, inspiring the future of business with AI+ Data +CRM. Leading with our core values, we help companies across every industry blaze new trails and connect with customers in a whole new way. And, we empower you to be a Trailblazer, too — driving your performance and career growth, charting new paths, and improving the state of the world. If you believe in business as the greatest platform for change and in companies doing well and doing good - you’ve come to the right place.
Position Description
For our customers who wish to get the most value out of Salesforce with an enterprise experience, they purchase our Signature Success Plan. Signature drives the right insights and people at the right time - which can make all the difference. When you have Signature, you unlock our deepest level of partnership, most skilled expertise, and tools to stay agile.
The Frontline Senior Manager/Director - Customer success manager ensures that their team of 8-15 Customer Success Managers consistently offers a premium Signature experience to our customers. This role isn’t just about leadership; it's about encouraging collaboration across various facets of Salesforce, from ensuring efficient allocation of the team to aligning the right resources for customer delivery. Simultaneously, they cultivate valuable executive relationships, handle risk with foresight, and deepen connections with our broader Salesforce teams.
Responsibilities
Preferred Qualifications and Skills
Shifts - Candidate should be comfortable working in AMER shifts as well.
Accommodations
If you require assistance due to a disability applying for open positions please submit a request via this Accommodations Request Form.
Posting Statement
At Salesforce we believe that the business of business is to improve the state of our world. Each of us has a responsibility to drive Equality in our communities and workplaces. We are committed to creating a workforce that reflects society through inclusive programs and initiatives such as equal pay, employee resource groups, inclusive benefits, and more. Learn more about Equality at www.equality.com and explore our company benefits at www.salesforcebenefits.com.
Salesforce is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Salesforce does not accept unsolicited headhunter and agency resumes. Salesforce will not pay any third-party agency or company that does not have a signed agreement with Salesforce.
Salesforce welcomes all.
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Job Description
We are seeking a highly experienced and dedicated Sr. Medical Director to lead our US-centric Medical Affairs team in the Pain therapeutic area. As a key member of our organization, you will have the opportunity to make a significant impact on improving patient outcomes through your expertise and strategic leadership.
As the Sr. Medical Director, you will be driving development and execution of the US Pain Medical Strategy. Your knowledge, expertise, communication skills, experience with the US healthcare system and your ability to build strong relationships with various external stakeholders including key thought leaders relevant to the management of pain will be instrumental in effectively representing Vertex, our science and our commitment to improving patient outcomes.
Internally, you will collaborate closely with the global medical affairs team, development and project teams, as well as our commercial, HEOR and development teams, to align with disease and brand priorities. You will play a key role in identifying and filling key data gaps to optimize clinical practice and patient outcomes.
Key Responsibilities:
- Develop US-centric medical affairs plans, including launch and Life Cycle Management plans.
- Interpret scientific data and determine the potential impact on medical thinking and practice, ensuring appropriate care and long-term health outcomes for patients in the US.
- Lead thought leader engagement initiatives, building strong relationships with key opinion leaders in the Pain therapeutic area.
- Serve as a representative of Vertex, actively engaging with external stakeholders such as thought leaders, patient advocacy groups, and medical conferences.
- Collaborate with the development team on late-phase clinical development trials in the US.
- Incorporate insights and needs into US and global strategies
- Serve as the Medical Affairs representative in various cross-functional working group
- Partner with stakeholders to design and deliver Phase IIIB/IV studies to support reimbursement and access needs in the US.
- Provide medical support for the preparation of US-specific reimbursement dossiers.
- Establish strong relationships and scientific communication with External Experts and Patient Advocacy groups in the US Pain therapeutic area.
- Represent Vertex at key external meetings and medical conferences.
- Participate in grant committee meetings and support Investigator Initiated Studies (IIS) review for Pain in the US.
- Conduct medical/scientific training for US-based Commercial and other internal stakeholders.
- Provide medical intelligence and support at relevant medical congresses
- Ensure compliance with US laws, regulations, and codes.
Skills and Experience:
- MD degree, with a specialty in an area that manages acute and/or chronic pain.
- 8+ years of experience in the biotechnology or pharmaceutical industry, with at least 5 years in US-focused Medical Affairs.
- Strong communication skills, with the ability to effectively present complex medical information
- Excellent relationship-forming capabilities and the ability to work in a matrix environment.
- Team-oriented with strong interpersonal skills and the ability to collaborate effectively.
- Creative thinker with the ability to see the big picture while focusing on specific tactical needs in the US healthcare environment
- Strong negotiation and persuasion skills, able to hold positions and ideas without alienating others.
- Ability to work in tight timelines and willingness to travel up to 40% of the time
Pain touches so many of us. Apply now to make a difference in the lives of patients and represent Vertex's commitment to advancing science and healthcare.
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Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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Responsibilities:
Mainly focus on sales strategy planning and business development to meet or exceed given Annual Sales target.
Support technical queries from external (e.g.end users, consultants, and partners)
Work closely with Solution team in articulating technology and product positioning to both business and technical users in the form of presentation or bid proposaland clarifications.
Work with Solution team in solution design and produce guide specifications support to consultants, integrators, and customers.
Respond to functional and technical elements of RFIs/RFPs including conducting of cost and solution analysis to ensure competitiveness of bid response.
Develop opportunities from assigned industries and customer segments
Act as single point of contact to the assigned customers account and manage the customersâ requirements and feedbacks to ensure satisfactory level
Coordinate with solution team and project team to deliver project in timely, satisfactorily and quality manner and ensuring project delivery is delivered in compliance with contractual and regulatory requirements
Resolve issues in a manner that is consistent with the company mission, values, and project objectives.
Identify customer's needs and sales opportunities from the leads received, and to help future growth through value-added engineering.
Develop and maintain close relationship with customers.
Bi-weekly update of Sales CRM, sales gap and forecast report.
Requirements:
Degree/Diploma in Mechanical or Electrical Engineering or equivalent.
Minimum 5 years Sales experience in Data Centre / Engineering & Building Services Industry
Self-driven with initiative
Proven and strong interpersonal skills to communicate well with customers, colleagues and vendors
Proven record of meeting sales quota
Proficient in Microsoft Office,Microsoft Visio, and Project
Read architectural, structural, mechanical and electrical blueprints and have a solid understanding of building services such as electrical, fire,and mechanical system.
Understanding of enterprise infrastructure control systems and network communications technology âInternet, Intranet, VPN, TCP/IP, Ethernet, etc. will be a plus.
Driving license and have own vehicle.
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