Associate Director, Medical Affairs Job at Connexion Systems & Engineering, Inc (Boston)

Associate Director, Medical Affairs

As the Associate Director, UCAN Medical Affairs, you will play a pivotal leaders...

Location

United States , Deerfield

Salary:

184000.00 - 253000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced healthcare degree with 10+ years of clinical experience
Background in ICU, Med-Surg, or Clinical Informatics strongly preferred
Prior Medical Affairs experience highly desirable
Proven experience within the healthcare or life sciences industry
Strong leadership, interpersonal, analytical, and problem-solving skills
Clinical trial experience with a solid understanding of Good Clinical Practice (GCP)
Working knowledge of biostatistics and clinical trial design
Strong digital fluency, including advanced PowerPoint capabilities
Expertise in literature review, synthesis, and scientific analysis
Confidence and effectiveness in public speaking and scientific presentations

Job Responsibility

Provide regional Medical Affairs leadership for new product development, ensuring scientific rigor and clinical relevance
Identify evidence-generation gaps and drive regional evidence strategies in collaboration with Global Business Unit (GBU) Medical Affairs teams
Develop and execute scientific communication and non-promotional education (NPE) plans aligned with product and portfolio strategy
Design, lead, and support advisory boards, clinical investigator meetings, roundtables, and scientific forums
Partner with cross-functional stakeholders to shape long-term Medical Affairs strategies, including comprehensive thought leader engagement plans
Represent Medical Affairs at regional, national, and international medical congresses, providing scientific support and translating emerging data into actionable insights
Monitor and communicate scientific trends, opportunities, and risks that may impact the business
Maintain strong alignment with Global Medical Affairs, ensuring collaboration across data generation, clinical trials, publications, advisory boards, CMEs, and literature strategy
Oversee Grants and Sponsorships, ensuring compliance, accurate documentation, and timely execution
Ensure strict adherence to all internal, legal, regulatory, and compliance standards

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Associate Director, Medical Affairs

As the Associate Director, UCAN Medical Affairs, you will play a pivotal leaders...

Location

United States , Deerfield

Salary:

184000.00 - 253000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced healthcare degree with 10+ years of clinical experience
Background in ICU, Med-Surg, or Clinical Informatics strongly preferred
Prior Medical Affairs experience highly desirable
Proven experience within the healthcare or life sciences industry
Strong leadership, interpersonal, analytical, and problem-solving skills
Clinical trial experience with a solid understanding of Good Clinical Practice (GCP)
Working knowledge of biostatistics and clinical trial design
Strong digital fluency, including advanced PowerPoint capabilities
Expertise in literature review, synthesis, and scientific analysis
Confidence and effectiveness in public speaking and scientific presentations

Job Responsibility

Provide regional Medical Affairs leadership for new product development, ensuring scientific rigor and clinical relevance
Identify evidence-generation gaps and drive regional evidence strategies in collaboration with Global Business Unit (GBU) Medical Affairs teams
Develop and execute scientific communication and non-promotional education (NPE) plans aligned with product and portfolio strategy
Design, lead, and support advisory boards, clinical investigator meetings, roundtables, and scientific forums
Partner with cross-functional stakeholders to shape long-term Medical Affairs strategies, including comprehensive thought leader engagement plans
Represent Medical Affairs at regional, national, and international medical congresses, providing scientific support and translating emerging data into actionable insights
Monitor and communicate scientific trends, opportunities, and risks that may impact the business
Maintain strong alignment with Global Medical Affairs, ensuring collaboration across data generation, clinical trials, publications, advisory boards, CMEs, and literature strategy
Oversee Grants and Sponsorships, ensuring compliance, accurate documentation, and timely execution
Ensure strict adherence to all internal, legal, regulatory, and compliance standards

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Associate Medical Director, Medical & Scientific Affairs

At KARL STORZ, we are dedicated to improving patient outcomes through cutting-ed...

Location

United States , El Segundo

Salary:

229400.00 - 310200.00 USD / Year

KARL STORZ

Expiration Date

Until further notice

Requirements

MD or DO degree required
8+ years of surgical experience, including residency training (general surgery or closely related specialty preferred)
Strong foundation in medical device technology, clinical evaluation, and patient safety principles
Demonstrated ability to communicate complex scientific concepts to diverse internal and external audiences
Excellent leadership, collaboration, and organizational skills
able to thrive in dynamic, cross-functional settings

Job Responsibility

Serve as a clinical and scientific expert in general surgery, video and imaging platforms, and operating room integration products
Partner cross-functionally with R&D, Regulatory Affairs, Quality, Legal, and Commercial teams to ensure clinical accuracy and sound medical decision-making throughout the product lifecycle
Lead and support medical safety initiatives, including post-market surveillance, product recalls, and risk assessments to safeguard patient care
Engage with Key Opinion Leaders (KOLs), facilitate advisory boards, and lead scientific and educational programs to advance product knowledge and adoption
Collaborate with Clinical Affairs to assess and communicate clinical evidence, literature, and research insights that guide strategic decisions
Provide medical input for product development, regulatory submissions, and educational content for healthcare professionals
Represent KARL STORZ in external scientific forums and peer-to-peer clinical discussions while maintaining the highest standards of compliance and professionalism

What we offer

Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too
3 weeks vacation, 11 holidays plus paid sick time
Up to 8 weeks of 100% paid company parental leave
includes maternal/ paternal leave, adoption, and fostering of a child
401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)
Section 125 Flexible Spending Accounts
Life, STD, LTD & LTC Insurance
We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
Fitness reimbursement of up to $200 annually

Fulltime

Associate Medical Director, US Medical Affairs

The Associate Medical Director will be responsible for contributing to and parti...

Location

United States , Morristown

Salary:

180000.00 - 210000.00 USD / Year

Alfasigma

Expiration Date

Until further notice

Requirements

MD/PhD/PharmD (or equivalent) with a minimum of 5 years of professional/clinical experience
At least 3 years of biopharmaceutical industry experience in Medical Affairs and/or Clinical Research is required
Experience working with professional societies and quality organizations preferred
Prior experience in Hepatology, Gastroenterology, or Immunology preferred
Ability to travel up to 20% required (mostly to congresses/ad boards), which may include overnight and/or weekend travel
Strong understanding of Medical Affairs functions, processes, and strategic execution
Track record of being held accountable for key individual deliverables with successful results required
Strong verbal and written communication skills are essential, including strong presentation skills
Excellent organization and multi-tasking skills
Strong interpersonal skills and problem-solving capabilities

Job Responsibility

Participate in the development of a cross-functionally aligned set of medical strategies for the US market needs, focused on commercialized as well as late-stage development indications/assets
Develop the strategy for professional medical association engagement in the US in conjunction with other US stakeholders as part of the broader professional society strategy
Support medical affairs data generation and dissemination working group(s) and collaborate with the Scientific Communications team to develop and execute aligned strategies/tactics for maximizing our scientific communication efforts
Support field medical activities and help to assess and address internal/external medical education needs in collaboration with the Field Medical and Scientific Communications teams
Perform scientific and clinical training for internal staff, including Commercial/Sales, on Alfasigma products and respective disease-related aspects
Lead and execute scientific advisory boards to generate strategic insights that inform medical affairs plans
Participate in or perform review of promotional and medical/scientific materials as the Medical Reviewer, following standard operating practices (SOPs) and in collaboration with Regulatory, Legal, and Commercial counterparts
Maintain strong relationships with the external thought leader and influencer communities
Contribute to, and support execution of the lifecycle management activities for Alfasigma’s commercialized indications/assets
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team

What we offer

401(k) plan with company match
Rewards and recognition program
Health care benefits (medical, prescription drugs, dental, and vision insurance)
Short and long-term disability coverage provided
Plan coverage for domestic partners
Paid parental leave benefits and adoption assistance
Tuition reimbursement assistance
A generous Paid Time Off program that includes 20 vacation days, 11 holidays, 4 personal days, and 2 volunteer days per calendar year
Numerous well-being and work/life programs

Fulltime

Associate Director, Regulatory Affairs

Responsible for global strategic planning of the portfolio within a business uni...

Location

United States , Deerfield

Salary:

176000.00 - 242000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelors Degree required, or country equivalent
Masters and/or PhD will be an advantage
Minimum of 8-year experience in RA or related medical device function, including at least 3-year experience managing people
Ability to work effectively in multinational/multicultural environment
Management skills
Sound basis of Scientific (Training/ Communications) knowledge
Expert knowledge of regulations, and experience with interpretation and application
Excellent written and verbal communication, presentation, and facilitation skills
Strong negotiation skills and significant experience in interacting with regulatory authorities
Established relationships with regulatory authorities

Job Responsibility

Develop and implement regulatory strategy aligned with business strategy
Lead FDA, EU MDR and global submission strategy
Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups
Participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
Initiate and maintain appropriate communication within the RA function and represent Regulatory Affairs with business units and other functions
Act as primary contact for meetings with the regulatory authorities including the planning and leadership
Implement policies to ensure ongoing compliance with regulatory requirements
May manage regulatory budget at project level
Independently lead global regulatory strategy development, planning, and implementation for multiple complex programs and platforms
May represent Baxter interests in industry and working groups

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Associate Director, Regulatory Affairs

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

United States , Deerfield, Illinois

Salary:

176000.00 - 242000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelors Degree required, or country equivalent
Minimum of 8-year experience in RA or related medical device function, including at least 3-year experience managing people
Ability to work effectively in multinational/multicultural environment
Management skills
Sound basis of Scientific (Training/ Communications) knowledge
Expert knowledge of regulations, and experience with interpretation and application
Excellent written and verbal communication, presentation, and facilitation skills
Strong negotiation skills and significant experience in interacting with regulatory authorities
Established relationships with regulatory authorities
Demonstrated ability to lead, mentor, and develop others for future growth and development

Job Responsibility

Responsible for global strategic planning of the portfolio within a business unit including development, implementation and management of plans and standards
Leads, mentors, and develops others in service of Baxter's objectives in alignment with PSS’s hospital bed segment
Participates in strategic LRP and AOP for Hospital Beds
Responsible for all aspects of regulatory strategy for the PSS hospital bed product segment
Provides quarterly regulatory intelligence impact assessments for Batesville, IN site
Oversee Notified Body consolidation activities for the PSS hospital bed group
Lead regulatory efforts for consistent delivery of CCS business objectives
regulatory policy and implementation
and identification and prioritization of key opportunities and risks
Mentors staff for 510(k) submissions, EU MDR submissions, MDD certificate extensions, and NPD and sustaining projects

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Associate Director / Director, Clinical Quality Assurance

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

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

Job Responsibility

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

Fulltime

New

Associate Director of Regional Accounts - Eastern US

The Regional Account Associate Director (RAD) is responsible for leading market ...

Location

United States

Salary:

Not provided

The Muse

Expiration Date

Until further notice

Requirements

A bachelor's degree is required, with an advanced degree preferred
At least 10 years of pharmaceutical experience, including a minimum of 3-5 years GPO, MSO and Non-Acute clinic customer account management and/or sales management and rare disease experience
Preferred experience working with infusion site of care delivering settings
Working knowledge of GPOs, Infusion center and Specialty Pharmacy
Demonstrated success with account management, market sales growth and product profitability
Proven performance in previous roles
Knowledge and/or understanding of contract of purchase performance and data agreements

Job Responsibility

Demonstrate broad knowledge of the regional healthcare industry including emerging trends, evolving customer segments and developing policies impacting patient flow, product flow and dollar flow
Lead negotiation and execution of customer contracts, including performance-based agreements and data agreements, to support access, accountability, and achievement of business objectives
Work with teams across Strategic Pricing and Contracting, Marketing, Sales, Medical Affairs, Insights and Analytics, Payer Channel Marketing, and Patient Support to implement brand strategies and deliver portfolio value
Provide leadership in developing account strategies by aligning with Strategic Account Plans, focusing on both short-term (12-24 months) and long-term (over 2 years) engagement and partnership objectives
Models the ability to influence others and lead without authority during complex situations, fostering collaborative problem-solving and reaching consensus
For identified key accounts responsible for executing business to business engagement for assigned products with key leaders in community clinics and health systems, including business, C-Suite, procurement, and financial decision-makers
Identify, pursue, and secure product adoption opportunities within GPO, MSO and Non-Acute clinic customers
Lead large-scale initiatives to drive product utilization and business growth

What we offer

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

Fulltime

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Associate Director, Medical Affairs

Job Description

Job Responsibility

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