The Associate Director Principal Medical Writer leads the creation and management of high-quality regulatory-compliant clinical documentation supporting drug development. This role involves implementing innovative digital technologies, managing cross-functional projects, and mentoring junior writers to ensure compliance and efficiency. The position requires deep expertise in clinical development processes, regulatory requirements, and document management systems.
Job Title: Principal Medical Writer Associate Director
Location: USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings
About the Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
Global Medical writing and Document management serves to generate timely, high quality, cost effective and regulatory compliant documents. Our mission is to synergize and harness evolving technologies pushing the edge of regulatory writing.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
Document Development
• Create high-quality regulatory-compliant clinical documents supporting product life cycle
• Ensure timely delivery while maintaining compliance with standards
Innovation
• Lead implementation of new digital technologies and AI solutions
• Drive process improvements for efficiency gains
Regulatory Expertise
• Prepare registration dossiers and Health Authority responses
• Monitor and implement regulatory documentation requirements
Project Management
• Lead cross-functional initiatives as Subject Matter Expert
• Drive change management within writing teams
Communication
• Update relevant stakeholders on project progress and needs
• Maintain accurate information in planning, tracking, and reporting tools Ensure consistent communication across ClinDoc functions
Coordination
• Mentor junior writers and review contract work
Quality & Training
• Develop training programs and documentation standards
• Build effective relationships with stakeholders and partners...
About You
Core Experience:
Six+ years as medical writer or equivalent specialist role
Proven track record leading multiple clinical documentation projects
Expert in clinical documentation preparation
Clinical Development Knowledge:
Demonstrated expertise in clinical development processes
Strong understanding of clinical study methodology and basic statistics
Knowledge of regulatory environment
Proficient in document management systems and authoring platforms
Professional Attributes:
Strong attention to detail and deadline management
Excellent organizational and follow-up abilities
Proven ability to work independently and in global teams
Technical skills:
• Expertise in electronic document management and Microsoft Office
• Proven experience in implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SA
#LI-SA
#LI-Onsite
#vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Keywords:
medical writer, clinical documentation, regulatory compliance, drug development, document management, clinical study methodology, regulatory writing, digital technologies, AI-assisted authoring, project management
$238k-356k yearly est. 6d ago
Looking for a job?
Let Zippia find it for you.
Director, Medical Safety (Scientist)
Jazz Pharmaceuticals 4.8
Carlsbad, CA jobs
If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information.
The Director, Medical Safety (Scientist) is a key member of the Medical Safety team, and provides leadership, line management, and/or mentorship for the junior safety scientists within Medical Safety organization. In close collaboration with Medical Safety Physician and/or Medical Safety Scientist line manager, this role leads, oversees and coordinates all Medical Safety activities for respective TA/ product franchise as well as Medical Safety organization as a whole. This role is responsible for ensuring up to date processes / procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management and/or driving innovation initiatives within Medical Safety organization. In close collaboration with Medical Safety Physician, this role is also responsible for contributing to regulatory submission safety strategy. Other responsibilities include but are not limited to: signal management activities, production of aggregate safety reports (e.g., DSURs, PADERs, PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (e.g, signal evaluation reports, health hazard evaluations, and RMPs), global leadership / representation of Medical Safety within the company (e.g., leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections.
Essential Functions
• Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program.
• Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness
• Drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns.
• Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation.
• Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit for purpose evaluation documents with clear conclusions, as required.
• Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate.
• Authors or provides guidance for the production of risk management plans (RMPs).
• Provides strategic input into regulatory requests / responses.
• Delivers clinical safety input into clinical development program.
• Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications.
• Participate in and/or lead internal safety surveillance meetings as well as joint safety meetings with licensing Partners, as needed.
• Provides medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements.
• Escalates issues / concerns to senior management in a timely and appropriate manner. • Mentors and trains junior members of the Medical Safety team.
Required Knowledge, Skills, and Abilities
Minimum Requirements
• At least 8 years of experience in drug safety, including at least 5 years of experience in surveillance / risk management.
• Ability to independently search clinical safety and literature databases for relevant information.
• Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management.
• Excellent medical writing skills, as well as proven ability to effectively lead interdisciplinary teams.
• In-depth knowledge of medical and drug terminology, as well as the clinical development process.
• Familiarity with MedDRA and safety databases; Proficient with Windows applications, and ability to learn new programs / databases.
Required/Preferred Education and Licenses
• Requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline.
Description of Physical Demands
• Occasional mobility within office environment.
• Routinely sitting for extended periods of time.
• Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
• Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
• Frequent computer use at workstation.
• May move from one work location to another occasionally.
• Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
• Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $200,000.00 - $300,000.00
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
By applying, you consent to your information being transmitted by JobG8 to the Employer, as data controller, through the Employer's data processor SonicJobs.
See Jazz Pharma Privacy Policy at and SonicJobs Privacy Policy at and Terms of Use at
$200k-300k yearly 1d ago
Associate Director, Medical Writing
Jazz Pharmaceuticals 4.8
Carlsbad, CA jobs
If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information.
Brief Description:
The Associate Director, Medical Writing, is responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables within one or more program.
S/he will work directly with cross functional teams to author regulatory documents (eg, protocols, clinical study reports, briefing books, submission documents, investigator brochures). For programs with multiple deliverables, s/he may be responsible for managing writers. The incumbent will ensure that strategically aligned communication points are conveyed in medical writing deliverables and that the communication points are consistent across program documentation. S/He will mitigate risk associated with medical writing and disclosure processes by contributing to Best Practices and SOPs.
This role has global responsibilities, including participation in global teams and interaction with regulatory agencies in multiple regions. This role may have line management responsibilities.
Essential Functions/Responsibilities
Works with the cross functional team to ensure effective communication of data in the respective documents.
Works with the cross functional team to ensure that communication needs for the clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical program lifecycle.
Analyzes study level documents for their ability to deliver the information required by the target audience (eg, health authorities).
Communicates proactively and efficiently within the MW team and across R&D.
Ensures quality of medical writing deliverables and that work on assigned projects adheres to departmental procedures / practices, and industry / international standards.
Possible oversight of contract medical writers to ensure efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines.
Collaboration and strategic partnership with cross functional team members to ensure understanding of program strategy and the nature of medical writing services required to deliver on company objectives.
Required Knowledge, Skills, and Abilities
Exceptional English language skills and ability to write and edit complex material to ensure accuracy, clarity, and effectiveness.
Clear understanding of lean authoring for clinical regulatory documents.
A solid understanding of the clinical development process, including the documents that are required at each stage.
For early development: knowledge of pre-clinical and nonclinical regulatory requirements and reporting is required.
Prior contribution to, and an understanding of, global submissions.
Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
Excellent written and oral communication skills and demonstrated coaching and problem-solving abilities.
Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
Ability to think strategically; demonstrated negotiating skills and resourcefulness.
Demonstrated ability to manage several projects simultaneously.
Ability to critically analyze and synthesize complex scientific information.
High degree of influencing skills in shaping and developing content and wording.
Demonstrated ability to work collaboratively; multicultural sensitivity, builds positive and productive relationships, seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions / proposals.
Successful track record of leading complex clinical / regulatory writing projects.
Demonstrated ability to make decisions even in the absence of complete information.
An excellent understanding of all aspect of ICH-GCP; keen insight on external clinical publication practices and standards (ICMJE, AMA, GPP).
Excellent organizational and time management skills and attention to detail.
Required/Preferred Education and Licenses
BA/BS with at least 8 years (or advanced degree with at least 5 years) writing experience in the pharmaceutical industry across therapeutic areas required. Advanced degree preferred.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $154,400.00 - $231,600.00
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
By applying, you consent to your information being transmitted by JobG8 to the Employer, as data controller, through the Employer's data processor SonicJobs.
See Jazz Pharma Privacy Policy at and SonicJobs Privacy Policy at and Terms of Use at
$154.4k-231.6k yearly 1d ago
Director, Medical Safety (Scientist)
Jazz Pharmaceuticals 4.8
Palo Alto, CA jobs
If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information.
The Director, Medical Safety (Scientist) is a key member of the Medical Safety team, and provides leadership, line management, and/or mentorship for the junior safety scientists within Medical Safety organization. In close collaboration with Medical Safety Physician and/or Medical Safety Scientist line manager, this role leads, oversees and coordinates all Medical Safety activities for respective TA/ product franchise as well as Medical Safety organization as a whole. This role is responsible for ensuring up to date processes / procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management and/or driving innovation initiatives within Medical Safety organization. In close collaboration with Medical Safety Physician, this role is also responsible for contributing to regulatory submission safety strategy. Other responsibilities include but are not limited to: signal management activities, production of aggregate safety reports (e.g., DSURs, PADERs, PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (e.g, signal evaluation reports, health hazard evaluations, and RMPs), global leadership / representation of Medical Safety within the company (e.g., leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections.
Essential Functions
• Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program.
• Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness
• Drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns.
• Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation.
• Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit for purpose evaluation documents with clear conclusions, as required.
• Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate.
• Authors or provides guidance for the production of risk management plans (RMPs).
• Provides strategic input into regulatory requests / responses.
• Delivers clinical safety input into clinical development program.
• Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications.
• Participate in and/or lead internal safety surveillance meetings as well as joint safety meetings with licensing Partners, as needed.
• Provides medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements.
• Escalates issues / concerns to senior management in a timely and appropriate manner. • Mentors and trains junior members of the Medical Safety team.
Required Knowledge, Skills, and Abilities
Minimum Requirements
• At least 8 years of experience in drug safety, including at least 5 years of experience in surveillance / risk management.
• Ability to independently search clinical safety and literature databases for relevant information.
• Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management.
• Excellent medical writing skills, as well as proven ability to effectively lead interdisciplinary teams.
• In-depth knowledge of medical and drug terminology, as well as the clinical development process.
• Familiarity with MedDRA and safety databases; Proficient with Windows applications, and ability to learn new programs / databases.
Required/Preferred Education and Licenses
• Requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline.
Description of Physical Demands
• Occasional mobility within office environment.
• Routinely sitting for extended periods of time.
• Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
• Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
• Frequent computer use at workstation.
• May move from one work location to another occasionally.
• Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
• Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $200,000.00 - $300,000.00
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
By applying, you consent to your information being transmitted by JobG8 to the Employer, as data controller, through the Employer's data processor SonicJobs.
See Jazz Pharma Privacy Policy at and SonicJobs Privacy Policy at and Terms of Use at
$200k-300k yearly 1d ago
Associate Director, Medical Writing
Jazz Pharmaceuticals 4.8
Palo Alto, CA jobs
If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information.
Brief Description:
The Associate Director, Medical Writing, is responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables within one or more program.
S/he will work directly with cross functional teams to author regulatory documents (eg, protocols, clinical study reports, briefing books, submission documents, investigator brochures). For programs with multiple deliverables, s/he may be responsible for managing writers. The incumbent will ensure that strategically aligned communication points are conveyed in medical writing deliverables and that the communication points are consistent across program documentation. S/He will mitigate risk associated with medical writing and disclosure processes by contributing to Best Practices and SOPs.
This role has global responsibilities, including participation in global teams and interaction with regulatory agencies in multiple regions. This role may have line management responsibilities.
Essential Functions/Responsibilities
Works with the cross functional team to ensure effective communication of data in the respective documents.
Works with the cross functional team to ensure that communication needs for the clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical program lifecycle.
Analyzes study level documents for their ability to deliver the information required by the target audience (eg, health authorities).
Communicates proactively and efficiently within the MW team and across R&D.
Ensures quality of medical writing deliverables and that work on assigned projects adheres to departmental procedures / practices, and industry / international standards.
Possible oversight of contract medical writers to ensure efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines.
Collaboration and strategic partnership with cross functional team members to ensure understanding of program strategy and the nature of medical writing services required to deliver on company objectives.
Required Knowledge, Skills, and Abilities
Exceptional English language skills and ability to write and edit complex material to ensure accuracy, clarity, and effectiveness.
Clear understanding of lean authoring for clinical regulatory documents.
A solid understanding of the clinical development process, including the documents that are required at each stage.
For early development: knowledge of pre-clinical and nonclinical regulatory requirements and reporting is required.
Prior contribution to, and an understanding of, global submissions.
Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
Excellent written and oral communication skills and demonstrated coaching and problem-solving abilities.
Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
Ability to think strategically; demonstrated negotiating skills and resourcefulness.
Demonstrated ability to manage several projects simultaneously.
Ability to critically analyze and synthesize complex scientific information.
High degree of influencing skills in shaping and developing content and wording.
Demonstrated ability to work collaboratively; multicultural sensitivity, builds positive and productive relationships, seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions / proposals.
Successful track record of leading complex clinical / regulatory writing projects.
Demonstrated ability to make decisions even in the absence of complete information.
An excellent understanding of all aspect of ICH-GCP; keen insight on external clinical publication practices and standards (ICMJE, AMA, GPP).
Excellent organizational and time management skills and attention to detail.
Required/Preferred Education and Licenses
BA/BS with at least 8 years (or advanced degree with at least 5 years) writing experience in the pharmaceutical industry across therapeutic areas required. Advanced degree preferred.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $154,400.00 - $231,600.00
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
By applying, you consent to your information being transmitted by JobG8 to the Employer, as data controller, through the Employer's data processor SonicJobs.
See Jazz Pharma Privacy Policy at and SonicJobs Privacy Policy at and Terms of Use at
$154.4k-231.6k yearly 1d ago
Director, Medical Safety (Scientist)
Jazz Pharmaceuticals 4.8
Philadelphia, PA jobs
If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information.
The Director, Medical Safety (Scientist) is a key member of the Medical Safety team, and provides leadership, line management, and/or mentorship for the junior safety scientists within Medical Safety organization. In close collaboration with Medical Safety Physician and/or Medical Safety Scientist line manager, this role leads, oversees and coordinates all Medical Safety activities for respective TA/ product franchise as well as Medical Safety organization as a whole. This role is responsible for ensuring up to date processes / procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management and/or driving innovation initiatives within Medical Safety organization. In close collaboration with Medical Safety Physician, this role is also responsible for contributing to regulatory submission safety strategy. Other responsibilities include but are not limited to: signal management activities, production of aggregate safety reports (e.g., DSURs, PADERs, PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (e.g, signal evaluation reports, health hazard evaluations, and RMPs), global leadership / representation of Medical Safety within the company (e.g., leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections.
Essential Functions
• Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program.
• Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness
• Drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns.
• Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation.
• Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit for purpose evaluation documents with clear conclusions, as required.
• Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate.
• Authors or provides guidance for the production of risk management plans (RMPs).
• Provides strategic input into regulatory requests / responses.
• Delivers clinical safety input into clinical development program.
• Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications.
• Participate in and/or lead internal safety surveillance meetings as well as joint safety meetings with licensing Partners, as needed.
• Provides medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements.
• Escalates issues / concerns to senior management in a timely and appropriate manner. • Mentors and trains junior members of the Medical Safety team.
Required Knowledge, Skills, and Abilities
Minimum Requirements
• At least 8 years of experience in drug safety, including at least 5 years of experience in surveillance / risk management.
• Ability to independently search clinical safety and literature databases for relevant information.
• Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management.
• Excellent medical writing skills, as well as proven ability to effectively lead interdisciplinary teams.
• In-depth knowledge of medical and drug terminology, as well as the clinical development process.
• Familiarity with MedDRA and safety databases; Proficient with Windows applications, and ability to learn new programs / databases.
Required/Preferred Education and Licenses
• Requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline.
Description of Physical Demands
• Occasional mobility within office environment.
• Routinely sitting for extended periods of time.
• Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
• Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
• Frequent computer use at workstation.
• May move from one work location to another occasionally.
• Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
• Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $200,000.00 - $300,000.00
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
By applying, you consent to your information being transmitted by JobG8 to the Employer, as data controller, through the Employer's data processor SonicJobs.
See Jazz Pharma Privacy Policy at and SonicJobs Privacy Policy at and Terms of Use at
$200k-300k yearly 1d ago
Associate Director, Global Oncology Medical Training Lead
Takeda 4.7
Boston, MA jobs
A leading global biopharmaceutical company is seeking a new team member to enhance training within its Oncology division. This role involves developing tailored training programs, collaborating with cross-functional teams, and ensuring compliance within medical affairs. Candidates must have a doctoral degree in a scientific discipline and significant experience in medical affairs or related fields. This position offers a hybrid working environment in Boston, MA, with a competitive salary range of $168,700 to $265,100.
#J-18808-Ljbffr
$168.7k-265.1k yearly 3d ago
Associate Director Strategic Business Planning and Execution, US Medical Affairs
Astrazeneca 4.6
Boston, MA jobs
Are you ready to make a significant impact in the world of rare diseases? As the Associate Director of Strategic Planning & Execution for US Medical Affairs, you will drive strategic initiatives and collaborate with Therapeutic Area (TA) Leadership teams to align projects with our overarching goals. Your role will involve analyzing, resolving, and communicating key strategic programs, enabling informed decision‑making that contributes to our success. With your project management expertise, you'll ensure projects are delivered on time, within scope, and on budget.
Responsibilities Strategic Partnership
Develop annual enterprise strategy for assigned TA and/or Function and ensure effective, efficient, and equitable delivery of key strategic programs and operational activities
Oversight of business progress against performance targets through outcomes and metrics tracking/reporting
Highlight and communicate US Medical impact and effectiveness throughout all levels of the organization
Proactively apply business acumen to ensure business continuity and identify future opportunities
Financial Reporting
Liaise between Finance and assigned TA and/or Function to communicate details of operating plan and to track/report on spend
Lead annual budget plan, quarterly reforecasts, and various ad‑hoc financial requests, identifying key opportunities and risks
Partner with assigned TA and/or Functional team to provide detailed financial reports, reconcile monthly accruals, and ensure timely receipts
Manage financial analysis and trend reporting for senior leadership and cross‑functional partners
Develop various training documents, liaising with USMA colleagues to ensure their full understanding of Alexion's financial processes
Operations
Facilitate strategic cross‑functional meetings for increased collaboration across global medical, patient advocacy, commercial, and HEOR
Manage system improvements/enhancements with a focus on continuous improvement
Liaise with Compliance and Legal to resolve questions and mitigate risk
Oversight of P2P activities for all projects for assigned TA and/or Function, including contract review and execution in alignment with Alexion policies
Facilitate vendor onboarding, MSA generation, and SOW development with internal and external stakeholders
Oversee the TA tactical plans and activity towards plan, develop primary and secondary tactics strategy and metrics reporting to plan. Actively communicate with Key stakeholders from inception through execution and monitoring of plan.
Essential Skills/Experience
Bachelor's degree required
7+ years in the pharmaceutical industry in a Medical Affairs organization
Project management certification strongly preferred
Strong knowledge of Compliance and Legal requirements in the Biopharma space
FP&A experience preferred, with proven ability to manage annual budget/forecasts
Self‑starter with strong leadership problem solving, and negotiating skills
Highly influential with proven ability to create/lead successful cross‑functional teams
Ability to interact professionally with all levels of the organization
Flexibility to adapt to changing project scope
Excellent analytical and communication skills, both oral and written
Demonstrated energy and enthusiasm, bringing a positive approach to all challenges
Highly ethical, with ability to maintain confidentiality with sensitive information
Meeting facilitation skills (personal organization, advanced preparation, follow‑up)
Strong teamwork and collaboration skills
A continuous improvement mindset
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life‑changing medicines. In‑person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.
The annual base pay for this position ranges from $150,202 - $225,304 USD Annual. Hourly and salaried non‑exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job‑related knowledge, skills, and experience. In addition, our positions offer a short‑term incentive bonus opportunity; eligibility to participate in our equity‑based long‑term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at‑will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
At AstraZeneca, we are driven by a passion for innovation in rare disease biopharma. Our commitment to transparency, objectivity, and ethics allows us to push scientific boundaries and translate complex biology into transformative medicines. With our global reach and resources, we are uniquely positioned to address unmet needs in rare diseases. Join us in our mission to help people live their best lives by exploring new ideas in a supportive environment that values diversity, innovation, and connection.
Ready to make a difference? Apply now to join our team!
Date Posted
10-Dec-2025
Closing Date
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
#J-18808-Ljbffr
$150.2k-225.3k yearly 1d ago
Associate Director, Medical Writing
Jazz Pharmaceuticals 4.8
Philadelphia, PA jobs
If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information.
Brief Description:
The Associate Director, Medical Writing, is responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables within one or more program.
S/he will work directly with cross functional teams to author regulatory documents (eg, protocols, clinical study reports, briefing books, submission documents, investigator brochures). For programs with multiple deliverables, s/he may be responsible for managing writers. The incumbent will ensure that strategically aligned communication points are conveyed in medical writing deliverables and that the communication points are consistent across program documentation. S/He will mitigate risk associated with medical writing and disclosure processes by contributing to Best Practices and SOPs.
This role has global responsibilities, including participation in global teams and interaction with regulatory agencies in multiple regions. This role may have line management responsibilities.
Essential Functions/Responsibilities
Works with the cross functional team to ensure effective communication of data in the respective documents.
Works with the cross functional team to ensure that communication needs for the clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical program lifecycle.
Analyzes study level documents for their ability to deliver the information required by the target audience (eg, health authorities).
Communicates proactively and efficiently within the MW team and across R&D.
Ensures quality of medical writing deliverables and that work on assigned projects adheres to departmental procedures / practices, and industry / international standards.
Possible oversight of contract medical writers to ensure efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines.
Collaboration and strategic partnership with cross functional team members to ensure understanding of program strategy and the nature of medical writing services required to deliver on company objectives.
Required Knowledge, Skills, and Abilities
Exceptional English language skills and ability to write and edit complex material to ensure accuracy, clarity, and effectiveness.
Clear understanding of lean authoring for clinical regulatory documents.
A solid understanding of the clinical development process, including the documents that are required at each stage.
For early development: knowledge of pre-clinical and nonclinical regulatory requirements and reporting is required.
Prior contribution to, and an understanding of, global submissions.
Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
Excellent written and oral communication skills and demonstrated coaching and problem-solving abilities.
Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
Ability to think strategically; demonstrated negotiating skills and resourcefulness.
Demonstrated ability to manage several projects simultaneously.
Ability to critically analyze and synthesize complex scientific information.
High degree of influencing skills in shaping and developing content and wording.
Demonstrated ability to work collaboratively; multicultural sensitivity, builds positive and productive relationships, seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions / proposals.
Successful track record of leading complex clinical / regulatory writing projects.
Demonstrated ability to make decisions even in the absence of complete information.
An excellent understanding of all aspect of ICH-GCP; keen insight on external clinical publication practices and standards (ICMJE, AMA, GPP).
Excellent organizational and time management skills and attention to detail.
Required/Preferred Education and Licenses
BA/BS with at least 8 years (or advanced degree with at least 5 years) writing experience in the pharmaceutical industry across therapeutic areas required. Advanced degree preferred.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $154,400.00 - $231,600.00
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
By applying, you consent to your information being transmitted by JobG8 to the Employer, as data controller, through the Employer's data processor SonicJobs.
See Jazz Pharma Privacy Policy at and SonicJobs Privacy Policy at and Terms of Use at
$154.4k-231.6k yearly 1d ago
Medical Director
Med First Primary & Urgent Care 4.1
Raleigh, NC jobs
Med First is committed to expanding access to high-quality primary care in underserved communities. We're looking for a MedicalDirector who can lead with both clinical excellence and operational insight- advancing value-based care and sustainable growth across 25+ clinics.
How You'll Make an Impact:
Lead clinical strategy, quality, and patient safety across diverse, community-based settings
Advance value-based care, care management, and use of innovative AI models
Partner with operations/finance on access, growth, and performance (MLR, quality, experience)
Develop clinical leaders, recruit/retain talent, and foster a culture of compassion + accountability
Provide direct patient care in one of our primary care sites
Who you are:
Board-certified (FM/IM) with 5+ years of clinical leadership, success in value-based and multi-site environments, and a mission-driven, collaborative mindset.
Location: Hybrid: 2 Clinic Days in a Med First Clinic/2 Admin Days remote
$169k-263k yearly est. 1d ago
Medical Science Liaison, Breast Oncology - San Francisco/UT/NV
Daiichi Sankyo 4.8
San Francisco, CA jobs
Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Summary
Daiichi Sankyo, Inc. (DSI) is currently seeking a Medical Science Liaison (MSL) to join the Field Medical Affairs Team. The MSL develops ongoing professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas. The MSL develops skills and competencies to educate healthcare professionals, DSI internal stakeholders (e.g., Medical, Marketing, and Sales), and decision makers in healthcare systems regarding therapeutic areas and related products developed and commercialized by DSI.
This is a US Medical Affairs, Field based role. This territory currently covers the following states: Northern CA, NV and UT
Responsibilities
Present disease state and Daiichi Sankyo product specific data to HCPs
Respond to unsolicited requests for medical information
Identify and appropriately facilitate engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) investigator-initiated research study proposals, 3) speakers for DSI Brand Speaker programs, 4) advisors for DSI scientific, clinical and marketing advisory boards
Gather customer insights regarding DSI and competitor products to help inform medical and commercial decision-making
Enhance professional expertise through attendance of select scientific meetings and professional conferences for the purpose of continuing education and scientific exchange with key opinion leaders
Develop positive working relationships with local and regional internal stakeholders to enhance DSI HCP relationships
Develop the ability to apply the appropriate methods to implement the FMA department strategy within his/her geography in alignment with Medical and Brand strategies
Complete administrative duties, including monthly expense reporting and field activity reporting
Represent the Medical Science Liaison function by participating in DSI meetings, functions, events
Additional duties and responsibilities
Provide innovation in enhancing and developing professional relationships with national and regional healthcare opinion leaders and HCPs to provide medical and scientific support for DSI initiatives
Ability to anticipate trends and capitalize on opportunities
Lead special projects/initiatives
Assist in the development of team members
Represent FMA leadership at DSI meetings, functions and events
Qualifications
Education Qualifications
PharmD, MD, PhD, NP or PA in a health sciences-related field or an equivalent combination of education and experience required
Experience Qualifications
MSL/Sr. MSL
1 or More Years' experience, including medical & scientific affairs, clinical practice, research, academic or US-managed markets preferred
Previous experience in Oncology, clinical research and medical education preferred
Principal MSL/Associate Director MSL
5 or More Years' experience including medical & scientific affairs, clinical practice, research, academic or US managed markets preferred
Previous experience in Oncology, clinical research and medical education preferred
Additional Qualifications
Must have a valid driver's license with a driving record that meets company requirements
Ability to travel up to 60%
Compensation and seniority level/title based on experience and qualifications.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer.
Salary Range
$150,800.00 - $226,200.00
#J-18808-Ljbffr
$150.8k-226.2k yearly 3d ago
Breast Oncology Medical Science Liaison
Daiichi Sankyo 4.8
San Francisco, CA jobs
A global pharmaceutical company in San Francisco is seeking a Medical Science Liaison to develop professional relationships with healthcare professionals and support medical initiatives. The candidate will present scientific data, respond to medical inquiries, and gather insights for decision-making. A PharmD, MD, PhD, NP, or PA degree is required, along with experience in medical science affairs and oncology preferred. This field-based role requires up to 60% travel and offers a competitive salary range of $150,800 - $226,200.
#J-18808-Ljbffr
$150.8k-226.2k yearly 3d ago
CardioRenal Medical Science Liaison: Field Impact Leader
Astrazeneca 4.6
San Francisco, CA jobs
A global biopharmaceutical company seeks a Medical Science Liaison in San Francisco to support Cardiorenal marketed products. The role involves engaging with healthcare professionals, providing scientific support, and identifying patient management barriers. Candidates should have an advanced clinical degree and up to 2 years of experience in a clinical or commercial setting. Strong communication and leadership skills are essential. The position offers competitive pay and benefits.
#J-18808-Ljbffr
$145k-199k yearly est. 2d ago
Director, Order Management Operations - Hybrid Care Logistics
Vertex Pharmaceuticals 4.6
Boston, MA jobs
A global biotech company in Boston seeks a leader for their US care management team. This individual will manage operations, ensuring exceptional customer support while collaborating across functions. The role requires strong leadership, 5+ years in a people-leader position, and 10+ years in biotech or pharma. The position offers flexibility in a hybrid working environment with competitive benefits, including a bonus structure and generous paid time off.
#J-18808-Ljbffr
Cookie Notice* Identify, gain access to, and develop peer to peer relationships with regional and national thought leaders, active and potential study investigators, providers at academic and non-academic institutions and professional organizations within assigned geography.* Demonstrate and maintain deep scientific expertise on assigned Ipsen products and therapeutic area including competitive landscape and gaps in patient care.* Engage in ongoing scientific exchange about the science and clinical application of Ipsen's portfolio to external stakeholders to gather insights about current practice, treatment landscapes, and emerging data.* Assist with Company Sponsored Studies (CSS), including investigator/site identification, site initiation visits, education to support enrollment, and feedback regarding operational management to ensure optimal site selection and performance.* Partner with Medical Affairs and Medical Information services to ensure accurate delivery of medical and scientific information, as needed. Respond to on and off-label questions with integrity, compliance, and adherence to legal, regulatory, and Ipsen guidelines, policies & procedures.* Represent Ipsen and US Medical Affairs Team during scientific conferences, continuing medical educational events, and medical meetings.* Respond to unsolicited requests regarding interest in investigator sponsored studies (ISS) and supports ISS submissions, initiation and closure through appropriate internal processes, as needed.* Lead the development and implementation of a regional territory plan* Train and facilitate speakers on Ipsen's products.* Work efficiently and balance all work to enhance performance and execute local medical strategies within planned timelines.* Engage in continuous independent learning within the therapeutic area and actively attend and participate in upskilling programs related to Ipsen molecules, products, disease states and relevant business topics.* Differentiate Ipsen as the valued scientific partner of choice through innovative initiatives, coordinated strategy, scientific communication, and patient centricity.* Build and cultivate a close working relationship with all US cross-functional team members, including field-based counterparts and home office-based team members, marketing, HEOR, medical/clinical operations, etc. while maintaining full compliance with relevant company, industry, legal and regulatory requirements.* Support cross-functional teams to ensure operations are patient-focused, including rapidly responding to internal and external requests to discuss specific situations and challenges and provide medical affairs support to all stakeholders.* 2-3 years related MSL work experience required.* Previous Rare Disease experience required.* Knowledge of Rare Disease customer segments and market dynamics.* Excellent planning, presentation, written and presentation communication skills.* Demonstrated ability to develop and maintain credible and scientific relationships with top experts in the field.* Highly developed interpersonal skills and the ability to function on a cross-functional team.* Demonstrated expertise in ability to synthesize and communicate medical information clearly.* Knowledge of PhRMA, OIG, and other guidelines relating to compliant medical communications.* Knowledge of rare disease customer segments and market dynamics* Demonstrated expertise in discussing scientific content and context to multiple audiences.* Fundamental understanding of clinical research* Excellent project management ability* Excellent oral and written communication and interpersonal skills* Thorough knowledge of regulatory environment* Strong leadership capabilities* Excellent collaboration skills* Ability to travel (50-70%) based on size of geography.### Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.
#J-18808-Ljbffr
$96k-168k yearly est. 3d ago
Senior Medical Science Liaison - Nephrology (Missouri/Iowa/Nebraska/ Illinois: South/Central)
Vertex Pharmaceuticals 4.6
Boston, MA jobs
Senior Medical Science Liaison - Nephrology (Missouri/Iowa/Nebraska/ Illinois: South/Central) page is loaded## Senior Medical Science Liaison - Nephrology (Missouri/Iowa/Nebraska/ Illinois: South/Central)locations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-26673**Job Description****General Summary:**The Senior Medical Science Liaison (Sr MSL) (Nephrology) for Povetacicept programs. Povetacicept (pove) is an enhanced, dual BAFF/APRIL inhibitor in pivotal development for the treatment of IgA Nephropathy (IgAN).The Sr MSL will serve as a scientific liaison to the medical/academic community and is responsible for establishing and maintaining relationships with Health Care Providers/Professionals (HCPs) to ensure the appropriate dissemination of clinical and scientific information regarding Vertex' compounds in a timely, ethical and stakeholder-focused manner. The Sr MSL will contribute to shaping the medical plan by providing external stakeholders' insights and contribute to the designing and execution of the Medical Affairs strategy and plan. The Sr MSL will engage HCPs in response to scientific educational and research needs with available Vertex resources and provide the latest emerging data in response to specific inquiries, as appropriate.**Key Duties and Responsibilities:*** Develops and fosters effective and trusting relationships with Thought Leaders (TL) and identifies and engages other appropriate HCPs resulting in scientific engagement with a large network of T1D and transplant-team care providers and opinion leaders. Additionally, understands the inter-relationships both within and between academic centers and utilizes this expertise to enhance Thought Leader and HCP engagements* Consistently incorporates all aspects of the SEM (Scientific Engagement Model) into all interactions, enhancing the quality of interactions and overall relationships as assessed by field coaching observations* Independently incorporates the medical plan into interactions and territory planning (i.e. listening priorities) and captures valuable feedback in the CRM system to inform internal stakeholders and assist in shaping the medical strategy* Possesses an in-depth understanding of the utility and functionality of the CRM system/data analytics tools, allowing for the time sensitive capture of interaction details. Uses CRM/Analytics to enhance future TL engagements and manage workload* Discusses scientific information effectively and compliantly with external stakeholders at an advanced level of communication for both disease state and product to external stakeholders as assessed by management coaching and field observations* In-depth conceptual and practical knowledge of payers in the region and possesses an in-depth understanding of the impact of payers on patient care delivery* Assists clinical development/clinical operations by fully understanding IB content and presenting IB material, providing nominations for trial sites as requested, providing end of study data reviews with investigators (as needed)* Represents Vertex at medical congresses by providing scientific session/abstract coverage, booth staffing coverage, routine TL interactions, contributing to the daily and end of congress summaries and may provide logistical guidance through organizing and scheduling abstract/session coverage and preparing and delivering the conference debrief (as needed)* May serve as a mentor or trainer for colleagues with less experience; for example, assisting with new hire MSL onboarding* Conducts all activities in compliance with Vertex policy and procedures and performs all administrative tasks in a timely manner such as CRM entry, vehicle mileage reporting, expense reporting, calendar entries, training assignments, etc.**Knowledge and Skills:*** Ability to complete goals within allotted timeframes, and deliver high quality results* Ability to help plan and complete projects in a constantly changing field-based environment* Ability to appraise and comprehend medical and scientific literature* Ability to effectively present clinical/scientific information in a credible manner in varied settings* Good knowledge of assigned geographic territory* In-depth understanding of healthcare regulatory environment* Apply proficient knowledge of relevant T1D and T1D management protocols, healthcare environment and landscape to articulate the medical and scientific value of our products* Demonstrated working understanding around the compliance and regulatory frameworks that govern the pharmaceutical industry and conducts compliant interactions with internal and external stakeholders.* In-depth knowledge of payers and unique medical information needs to support access and appropriate use of Vertex medicines* Good knowledge of Health Economics and Outcomes Research* Fluent in English (oral and written)**Education and Experience:*** Minimum requirement for advanced biomedical or life sciences degree (ex. Masters, NP, PA)* Requires minimum of 3-4 years of experience as an MSL supporting Nephrology programs or in other medical affairs roles in the pharma/biotech industry or the equivalent combination of education and experience.* Previous training or experience in designated therapeutic area is helpful Pay Range:$171,300 - $245,000Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**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.
#J-18808-Ljbffr
$171.3k-245k yearly 4d ago
Director of Trauma & ECC: Lead Care & Improvement
Academy of Managed Care Pharmacy 3.4
Tyler, TX jobs
A healthcare organization is seeking a Director of Trauma in Tyler, Texas. The ideal candidate is a registered nurse with leadership experience in trauma care, holds a Master's degree, and has strong communication skills. Responsibilities include program oversight, educational opportunities for staff, and liaising with administration for quality trauma care. This full-time position requires active participation in budget processes and performance improvement initiatives.
#J-18808-Ljbffr
$50k-76k yearly est. 2d ago
Senior Oncology Medical Science Liaison - Field Leader
Verastem Oncology 3.7
Chicago, IL jobs
A leading oncology company is seeking a Medical Science Liaison (MSL) to engage with healthcare providers, providing education on investigational products and supporting research collaborations across multiple states. Candidates should have an advanced clinical degree, oncology experience, and excellent communication skills. This role requires significant travel across Illinois and surrounding areas to maintain key relationships and educate medical professionals. Join us in advancing cancer treatment innovations.
#J-18808-Ljbffr
$88k-165k yearly est. 4d ago
Medical Science Liaison / Senior Medical Science Liaison (Midwest)
Verastem Oncology 3.7
Chicago, IL jobs
Company Profile:
At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We've successfully launched this innovative combination therapygate in the U.S. and are exploring regulatory pathways for Europe and Japan.
We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients.
Summary
The Medical Science Liaison (MSL) role is the field-based medical/scientific expert for Verastem Oncology, focusing on engagement with healthcare providers to provide fair/balanced education on Doc investigational products, understanding the evolving therapeutic landscape, and supporting research collaborations across the portfolio.
Territory includes IL, MN, MO, IA, ND, SD, NE, and WI. Preferred locations for candidates to reside include Chicago, Minneapolis, and St. Louis.
Roles and Responsibilities< strangely> MSL:
Identifies, establishes, and maintains collaborative relationships with key investigators, institutions, groups and consortia in disease state areas of strategic focus forandung company.
Provides education to the medical community on company's investigational products and disease areas of focus.
Increases company visibility and enhances professional interaction with current and future oncology leaders.
Participates in medical education for healthcare professionals, including formulary (P&T) committees, through presentations at appropriate venues.
Works with the appropriate departments/personnel at clinical sites to ensure required education and training are होटल provided Completable.
Identifies clinical research opportunities that are consistent with company objectives.
Is the primary territory contact for the investigator-initiated research program, facilitating the processheiro concept submission through publication.
Identifies and communicates key clinical and research insights from oncology leaders to help shape company research.
Maintains a high level of clinical and scientific expertise through ongoing training and self-education, including attendance of relevant conferences, scientific workshops, and review of key publications.
Gathers and disseminates competitive intelligence in a compliant manner.
Takes advantage of opportunities to mentor other MSL team members, and actively contributes to cross-functional Medical Affairs team.
(language) Effectively executes administrative aspects of regional field activities.
Substantively contributes to, and provides medical leadership for internal cross functional programs/projects.
Provides responses to unsolicited requests for medical information, often in direct collaboration with Medical Information Services personnel.
Completes accurate and timely reports, project plans, and required documentation requests.
\-print>
Senior MSL:
The senior MSL will have all the responsibilities of an MSL and will have also consistently demonstrated core competencies and will assume broader responsibilities, that may include one or more of the following.
Substantively contributes to scientific publication planning, slide-deck development, training initiatives and the development/implementation of a Medical Strategy Plan.
Leading national level priority projects or cross-functional initiatives on behalf of Medical Affairs.
Leading interactions for specific select priority projects with external collaborators or groups.
Mentoring or coaching responsibilities for other MSLs especially new hires.
Coordinating with MA Training for identifying.constraints delivering advanced training initiatives
Experience, Education and Specialized Knowledge and Skills MSL:
Advanced Clinical/Science degree (MSN, PharmD, PhD) or professional credentials/ equivalent required with prior experience in the biotech/pharmaceutical industry, strongly preferred.
Prior MSL or relevant experience is strongly preferred.
Minimum of 3 years oncology experience, especially in gynecologic oncology, is strongly preferred.
Knowledge of applicable treatment, compliance, and regulatory guidelines.
Excellent interpersonal communication and presentation skills.
Strong problem solving, decision-making, and negotiation skills.
Ability to think strategically and apply knowledge and analytical skills.
Ability to summarize complex scientific information and present in a clear, concise, confident, and scientifically accurate and balanced manner to a range of audiences.
Ability to network and partner with external customers, including medical thought leaders, academic institutions, research consortia, and practice networks.
Thrives in a team environment and enjoys cross-functional collaboration; positively contributes to team culture.
Possesses demonstrable effective leadership skills (by example and through accomplishments) and can step forward to handle challenges within scope of authority.
Demonstrates deep therapeutic competency; stays abreast of trends and new information in the therapeutic/translational science area, as well as the profession at large.
Senior MSL:
For Senior MSL must meet the qualifications for MSL with a minimum five (5) years in Pharmaceutical Industry Medical Affairs as MSL, candidates with solid tumor experience preferred.
Ability to travel up to 65% of the time: As this is a customer-facing position, and the geographic territory expected to!!!!!/{
Knowledge of treatment guidelines (NCCN, ASCO, ESMO, etc.), clinical research processes, FDA regulations, CMS reimbursement coverage process, and OIG guidelines.败段>
Knowledge or experience in ovarian cancer/gynecologic oncology is a plus.
Must have the ability to network and partner with important external customers, including medical thought leaders, academic institutions, large group practices, NCI Cooperative Group leadership and members, medicaldirectors of medical groups or insurance carriers, as well as pharmacy directors.
Must be highly articulate and self-confident during formal and informal presentations; able to convey complex, scientific ideas fluently to any audience.
Travel:
Approximately 60-70% domestic travel is required.
#J-18808-Ljbffr
$88k-165k yearly est. 4d ago
Director Value Based Care
Med First Primary & Urgent Care 4.1
Raleigh, NC jobs
Med First Primary and Urgent Care is one of the largest independent family practice groups in the state of North Carolina. Our innovative hybrid model of delivering urgent care, primary care and occupational medicine care delivers exceptional patient care to the communities that we serve. Med First is growing rapidly and expanding into both rural and urban communities throughout North and South Carolina. Our mission is to fill primary care service gaps within underserved communities.
As a leader in accountable care organizations (ACOs) and population health management, we're committed to forward thinking programs that emphasize preventive care, chronic disease management and integrated delivery systems.
In this pivotal leadership role, you'll drive our value-based care (VBC) strategy, overseeing programs that reward quality outcomes. You'll collaborate with clinical leaders, analytics teams, and external partners to design and implement initiatives that enhance patient experiences, lower costs, and achieve superior performance in risk-based contracts. This is a chance to shape the future of healthcare in a dynamic, mission-driven environment.
Key Responsibilities
Lead the development and execution of VBC strategies, including ACOs, bundled payments, and shared savings programs
Oversee clinical initiatives focused on total cost of care reduction (e.g., chronic care management, readmission prevention, senior care programs)
Partner with providers to educate on VBC tools, workflows, and performance metrics; drive adoption of best practices
Analyze data to identify opportunities, monitor KPIs (quality metrics, utilization, RAF scores), and implement performance improvement plans
Negotiate and manage value-based contracts with payers, ensuring alignment with organizational goals
Build cross-functional teams and foster collaborations to support population health and care coordination
Stay abreast of regulatory changes (e.g., CMS guidelines, MIPS) and industry trends in VBC
Qualifications
Bachelor's degree in Healthcare Administration, Business, Nursing, or related field; Master's (MBA, MHA, MPH) or clinical degree strongly preferred
7+ years of progressive experience in healthcare, with at least 5 years in value-based care, population health, or managed care
Proven track record in leading VBC programs, contract negotiations, and achieving quality/cost targets
Deep knowledge of VBC models (e.g., ACOs, risk adjustment, shared risk), reimbursement methodologies, and healthcare regulations
Strong analytical skills with experience in data-driven decision-making and performance metrics
Preferred Skills
Experience with Medicare/Medicaid programs, chronic care management, or clinically integrated networks
Leadership in care transformation initiatives, such as reducing ED visits or managing chronic diseases
Excellent communication and stakeholder management abilities, with a focus on provider engagement
What We Offer
Competitive salary (depending on experience and location)
Performance-based bonuses and incentives tied to VBC outcomes
Comprehensive benefits: health, dental, vision, 401(k) match, and generous PTO
A collaborative, innovative culture committed to health equity and clinician well-being