Sr. Project Manager, Packaging Engineer
Remote or Philadelphia, PA Job
through AgileOne
This is a remote position. However, you MUST be able to commute to Philadelphia, PA when needed. 25% travel required.
*Must have experience in pharmaceutical/packaging prefilled syringes*
This role serves as an essential part of the External Manufacturing & Network Equipment team, overseeing product and technology transfers to Contract Manufacturing Organizations (CMOs). The role involves leading technical interactions with external packaging partners, which are Contract Manufacturing Organizations in the ExM space. The incumbent will work closely with other ExM functions (Quality, Operations, Supply Chain, Procurement) and technology experts within the Centers of Excellence. The engineer will leverage their scientific, technical, and business expertise to lead teams in solving complex packaging issues, optimizing processes, and ensuring compliance, focusing on developing and executing primary and secondary packaging components for Small and Large Molecule assets, assembling Medical Device Combination Products, designing packaging equipment for prefilled syringes, and ensuring packaging process control and efficiency.
Core Responsibilities:
Tasked with leading and implementing technology transfers, qualifications, validations, process enhancements, and change controls for projects involving Small and Large Molecule, medical devices, combination products, and prefilled syringes.
Assurance of compliant packaging and assembly process transfer, site readiness and execution excellence.
Offer technical expertise in quality and supply investigations with external packaging partners. Lead discussions on packaging processes, equipment, and components to help identify root causes and develop effective corrective and preventive actions.
Collaborate with internal packaging teams on project timelines, development of primary, secondary, and tertiary packaging components, testing methods, packaging processes, serialization requirements, and transport/storage systems for the finished product.
Collaborating with external packaging partners in weekly meetings to ensure project tasks are executed according to the project schedule.
Collaborate with external packaging partners to ensure packaging readiness, including component specifications, operation process, risk assessment (FMEA), testing method transfer, and line qualifications (IQ, OQ, PQ) and validation (PPQ).
Oversees Change Control activities for tech transfer workflows to ensure timely task execution.
Operating independently while ensuring coordination, communication, and oversight on all technical aspects related to the involved External Packaging partners.
Education Minimum Requirement:
A bachelor's degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline (such as Chemical Engineering or Material Engineering) is mandatory.
Required Experience and Skills:
Minimum of 10 years' experience in the medical device, prefilled syringe packaging, and combination product engineering and pharmaceutical field, with extensive practical knowledge in supporting packaging operations, managing packaging materials and components, and overseeing packaging processes
Strong preference for candidates with leadership experience at a pharmaceutical packaging facility or an External Manufacturing site.
Extensive experience in handling Capital packaging equipment projects, including technology transfers, designing packaging lines, creating purchase specifications, managing equipment installation and validation, pursuing operational excellence, and troubleshooting on the shop floor.
Broad experience with devices, combination products, covering design control to product and technology transfer for both new and existing packaging facilities.
Exceptional project management skills, from conception and initiation, through project close-out.
Thorough knowledge and proven expertise in GMP application and quality systems, particularly in process and equipment qualification, change control, deviation management, and cleaning qualification.
Expert grasp of relevant scientific or technical concepts to handle routine and complex tasks, along with advanced practical knowledge of techniques applicable to these tasks.
Experience with key manufacturing change control compliance systems such as Veeva and/or other similar systems
Extensive experience with quantitative decision tools for risk management and options analysis to support risk-based decision making.
Exhibited leadership qualities and inclusive practices in managing a diverse, cross-functional team.
Familiarity with the regulatory standards of key pharmaceutical markets, such as USFDA cGMPs and EMA guidelines.
Demonstrate ability to have a continuous learning mindset and commitment to experiment, learn and embrace informed risk taking and doing things in new ways without fear of failure.
Adopt a critical mindset in decision-making to ensure thorough analysis while considering potential impacts on key stakeholders.
Ability to serve as a change agent to work collaboratively and act with an enterprise mindset to make appropriate tradeoffs for the project & organization's greater good.
Strong analytical and decision-making abilities, combined with outstanding oral and written communication skills.
Manager, Process & Procedures Operations
Remote Job
The Manager Process and Procedures Operations is responsible for the quality review of procedural documentation and system metadata to ensure deliverables adhere to standards and identify and evaluate issues and/or gaps in procedural document content; in collaboration with P&P Ops Mgr and Author, propose effective solutions.
In this role, a typical day might include:
Manage workflows for Administrative and simple quality changes
for continuous improvements to further strengthen procedural document development
Prepares project-specific initial impact assessment
Support inspection management activities by providing copies of procedural documents, as requested
Negotiates complex situations without direct authority
This role might be for you if have:
Solid understanding of GCP, GVP and regulatory requirements
Demonstrated proficiency in project management, collaboration and negotiation of complex situations
Self-motivated with the ability to work effectively in a dynamic environment
Ability to apply critical thinking and situational analysis to solve problems and manage multiple priorities with varying levels of urgency
To be considered for this opportunity, we require a Master's degree and 4 years of relevant experience or a Bachelors degree with 7 years of experience.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$113,100.00 - $184,700.00
Oncology Regional Medical Scientific Director - Thoracic Malignancies - Southern CA (Remote)
Remote or Rahway, NJ Job
Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio.
The Oncology Regional Medical Scientific Director, RMSD, is a credentialed (i.e., MD, PhD, or PharmD) therapeutic and disease expert who engages in scientific exchange with leaders in the external medical and scientific community. Scientific exchange does not include promotional claims about any drug, vaccine or biologic product. RMSDs provide to Scientific Leaders (SLs) balanced, factual, scientific information about non-product areas of interest to the company. The RMSD provides research support to our Investigator-Sponsored and Company-Sponsored Trials to enhance the understanding of the scientific foundations and goals of the study, support patient enrollment and retention efforts for a given study or address Investigator questions. RMSDs also respond to scientific questions from SLs, including questions about company products. RMSDs have no sales objectives or accountability for prescribing or sales of any company product and are required to avoid any situations that could create the appearance that they have such responsibilities. An RMSD may not comment on or make suggestions with respect to the diagnosis, treatment, or circumstances of a specific patient.
Location:
This position covers the territory of southern CA, primarily Los Angeles, but will exclude San Diego. Applicants must reside within the assigned territory.
Up to 50% travel required with some overnight.
Primary Responsibilities
Develop professional relationships and communicate with national and regional scientific leaders to ensure access to medical and scientific information on areas of therapeutic interest and company products.
Conduct peer to peer scientific discussions and maintain a reliable presence with those scientific leaders to ensure they have a medical contact within the company.
Upon request from Global Clinical Trial Operations (GCTO), support Company-Sponsored Trials to enhance the understanding of scientific foundations and goals of the study, support patient enrollment and retention efforts or address investigator questions.
May initiate discussion with potential investigators to determine the level of interest and qualifications for a specific compound or trial.
Recommend potential study sites to Global Clinical Trial Operations (GCTO)/Clinical Research.
Address requests from investigators for information regarding participation in our Research and Development Division's studies.
Address scientific questions.
Studies to enhance the understanding of the scientific foundations and goals of the study, support patient enrollment and retention efforts or address investigator questions.
Investigator-Sponsored upon request from Global Center for Scientific Affairs (GCSA), support company
Share the company's "˜areas of interest' and discuss study concepts to assess scientific merit and alignment with the company's research strategies.
Respond to unsolicited requests for assistance from potential investigators in submitting research proposals by providing internal guidelines or technical and scientific advice.
Education and training to maintain current knowledge and understanding of dynamic scientific and clinical environment in the company's areas of interest.
Direct scientific leader inquiries on issues outside of RMSD scope of responsibilities (e.g., grants) to appropriate company resources consistent with applicable policies.
When requested by our Research and Development Division, serve as a resource for the identification of potential investigators for consideration for participating in phase II-IV clinical development programs
In response to unsolicited requests from scientific leaders, provide areas of interest and general high-level information regarding the company Investigator Study Program process.
Serve as a role model for other field medical team members, including on-boarding and/or therapeutic training partner.
Attend scientific and medical meetings.
Education Minimum Requirement
PhD, Pharm.D, MD, DNP
Required Experience and Skills
Clinical (patient care) or deep research experience in assigned therapeutic area(s) beyond that obtained in the terminal degree program.
A minimum of 3 years' experience and proven therapeutic competence in the oncology.
Capable of conducting doctoral level discussions with key external stakeholders
Strong focus on scientific education and dialogue
Business and market knowledge, including quality management.
Excellent interpersonal, communication, and networking skills
Must possess a thorough understanding of the United States Federal Drug Administration (FDA), Office of Inspector General (OIG), Health Insurance Portability and Accountability Act (HIPAA) and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry and its customers.
Must be able to organize, prioritize, and work effectively in a constantly changing environment.
Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Access).
Preferred Experience and Skills
Field-based medical experience
Clinical research experience
Demonstrated record of scientific/medical publication
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$206,200.00 - $324,600.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
50%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
Yes
Hazardous Material(s):
n/a
Job Posting End Date:
02/11/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Technical Applications Specialist-(Remote) 1 (282330)
Remote or Charlotte, NC Job
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
Your Role:
The position will work with the local Commercial team members to support sales opportunities in the Southeast United States. As part of this team, you will leverage your expertise and strategic insights in the field of downstream technologies including filtration and purification portfolios to effectively collaborate with commercial partners and drive sales. Use your understanding of customers, current industry drivers and trends, together with an appreciation of competition dynamics to effectively identify strategic opportunities to gain market share and grow the business. You will also bring customer and commercial feed-back to leadership, business, & strategy to share best practices and identify potential gaps. Position involves 30% domestic travel to customer locations within Southeast.
Who You Are
Minimum Qualifications:
Bachelor's Degree in Biology, Chemistry, or other scientific discipline or Chemical Engineering, Mechanical Engineering, or other engineering discipline
1+ years of downstream purification experience in the biopharma industry
1+ years of experience with development of TFF and/or Clarification purification unit operations
Preferred Qualifications:
Master of Business Administration
5+ years direct experience with development and implementation of purification unit operations, ideally as a Process Development Scientist
Demonstrated ability to establish strong partnerships with internal and external partners
Experience working in a sales or marketing organization
Demonstrated ability to communicate clearly, concisely, and effectively to diverse audiences through both written and oral communications
Strong customer and sales orientation
Strong experience in downstream purification operations, with an emphasis on Clarification and Tangential Flow Filtration
RSREMD
Pay Range for this position - $70,000 - $120,000/year
Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit ********************************************************
Associate Director, Field Medical Affairs - Gastroenterology-Allergy-ENT (NY, NJ, VT)
Remote Job
As an Associate Director, Field Medical Affairs, you will play a pivotal role as a field-based professional within Gastroenterology, Allergy, and Rhinology to support the clinical and business objectives across the product life cycle. We deliver strategic and operational support by establishing, developing and maintaining scientific exchange with medical specialists, health care professionals, and payers, aligned with our strategic objectives. We provide clinical and health economic information that enhances the value and appropriate use of Regeneron products. You will work with clinical research sites and investigators, and support of research activities as directed by the Global Medical Functional head.
Responsibilities of this role are to ensure accurate exchange and distribution of clinical and scientific information relevant to in-line and pipeline products in a timely, ethical and customer-focused manner.
Territory: NY, NJ, VT
A typical day may include:
• Engaging in scientific discussions with medical and scientific specialists, including Healthcare Professionals and population health decision makers (“payers”) consistent with Medical Affairs objectives.
• Demonstrating deep scientific expertise related to assigned molecules/products and the associated therapeutic area to exchange relevant information and insights with specialists within a region.
• Building and developing relationships with key external scientific and medical specialists and organizations in a region to ensure strong understanding of evolving healthcare trends across the relevant therapeutic area landscape.
• Shaping and executing local medical strategy based on Global Medical Affairs strategy within planned timelines.
This may be for you if you:
• Enjoy working independently in the field, while having an impact on our mission.
• Are passionate about developing knowledge of and sharing clinical scientific data.
• Enjoy working collaboratively and building relationships in academic and clinical practice settings.
• Possess the innate ability to balance multiple initiatives, prioritize them and execute them independently, while excelling at keeping all partners advised and engaged.
To be considered for this position, you must have an advanced Clinical/Science Degree (e.g., MD, PharmD, PhD) with a minimum of 5 years related work experience (clinical, managed care, or industry experience). Experience in a Field Medical Affairs position (Medical Science Liaison) is required. Experience in Immunology is required; Gastroenterology or Allergy experience is preferred. It is required to have the ability to communicate and disseminate scientific and clinical data.
Residency in the territory is required.
#msl #medicalscienceliaison
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$173,500.00 - $283,100.00
Regional Account Manager
Remote Job
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, cancer, high LDL-cholesterol, atopic dermatitis and ultra-orphan conditions and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
A Typical Day Might Look Like the Following:
The Regional Account Manager (West) reports to the Senior Director, Payer Access. This role is responsible for developing key relationships with targeted regional commercial payers as well as select IPAs, IDNs and ACOs in the described geography. This position will maintain account management to attain key objectives for the entire Regeneron-owned product portfolio. The position will be responsible for implementing short- and long-term business initiatives to ensure appropriate coverage and coding within the specific managed market segments and for communicating these items with field sales, reimbursement and field medical teams on an on-going basis. The regional account manager will work closely with the national account directors on business planning and strategy and with field sales for pull through in the described geography.
• Assess and monitor product positioning within each targeted payer and channel customer. When appropriate, take action to move payer decisions in a direction that results in open access for patient care.
• Develop strategic plans for regional customers who may include select commercial payers, IDNs, IPAs, ACOs and other account targets as defined by Market Access leadership.
• Cross-functional collaboration with National Account Directors, Field Reimbursement (RBMs and Directors), Field Sales (RDs/MSs and Director Strategic Accounts) and internal corporate partners to ensure appropriate market coverage and support.
• Develop short- and long-term business planning for regional accounts, that addresses overall business unit, brand and corporate initiatives and goals. Work with management to assess progress and track progress.
• Assess competitive market landscape and opportunities for improved or expanded market penetration and adoption.
• Focus on a vertical integration plan within all targeted regional accounts, which includes payer Medical/Pharmacy and Purchasing Directors (clinical and administrative), case managers, and other medical management team members. In addition, efforts should include working with regional affiliates in executing pull-through strategies from corporate partners.
• Work closely with Managed Markets stakeholders to assist in segment support, which includes Managed Markets strategic imperatives implementation, brand initiative planning and strategy pull-through, RBM and trade team collaboration for segment support, while ensuring optimal pull through effectiveness for all patient support and access programs.
• Reporting of progress in regional accounts through business plan updates to management and internal partners on a regular basis.
• Monitor, track and improve key performance indicators as identified by scorecard metrics.
Regional Account Manager - West (CA, OR, WA, ID, MT, WY, UT, CO, NM, AZ, NV, AK, HI)
This Position Might be for You if:
• Work harmoniously with Commercial teams to assure adherence to all compliance guidelines.
• Effectively implement and manage all programs as directed by Market Access leadership, including providing input to Managed Markets Marketing to assist in the development of segment marketing programs and tools.
• Provide frequent market segment updates to Commercial leadership and functional area partners. Map important provider and regional payer trends, and current Managed Markets landscape, competitive intelligence, and positioning, to the overall strategic initiative and pull-through outcomes of the Managed Markets Access Team.
• Serve as a subject matter expert to support all functional area partners on assigned managed market topics. Collaborate closely with other stakeholders within the Regeneron Commercial team to ensure consistent exchange of important payer information and field messaging.
• Implement strategies and tactics to support appropriate product placement and reimbursement (coverage, coding, payment and patient access) across Managed Markets and regional payer customers.
• Create clear messages for dissemination to RBMs and Sales partners on important payer trends, reimbursement changes, and billing requirements that will affect product utilization.
• Represent the Managed Markets organization at identified regional payer organizations and other industry associations or entities.
• Manage expenses within assigned budgetary allocations to ensure operational margin goals are achieved.
To be considered for this role you must have a Bachelor's degree and/or Master's degree from an accredited college or university. 8+ years of "progressive" industry/relevant professional experience; including strong knowledge of reimbursement, IPA/IDN/ACO organizational structure. Current Managed Markets experience with regional commercial payers and/or experience calling on IPAs, IDNs or ACOs in the assigned geography. A strong understanding of BlueShield California, Premara Blue Cross, Cambia Health Solutions (Regence), SelectHealth, BCBS of Arizona and/or HMSA is desirable. Extensive Part B experience and fundamental understanding of buy-and-bill marketplace is mandatory. A strong oncology background is a plus. Ability to accommodate 40-60% travel depending on home-base. This position supports the West. Candidate must currently live within the geography, preferably with easy access to a major airport.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$174,000.00 - $217,400.00
Director IT Quality Assurance & Compliance
Remote or Ridgefield, NJ Job
As a Director of IT, Quality Assurance and Compliance you will lead and manage a team, consisting of 20 to 30 members, including direct reports. The focus of this role is to provide leadership, coaching, and technical support to the Corporate IT QA & Compliance Management Team, the supporting IT and business functions, and Managed Service Providers. We provide regulatory compliance support and services continuing to advance the principles of regulatory compliance throughout the IT organization.
This is an on-site position for 3+ days/week at our Sleepy Hollow, NY or Basking Ridge, NJ office. If eligible, we can offer relocation benefits. We cannot offer a fully remote option.
A typical day may include the following:
Collaborate with Manufacturing, Research and Clinical Studies QA teams to ensure seamless integration of IT quality assurance practices.
Oversee the preparation and management of our Health Authority and internal company audits. Ensures all IT-related aspects are compliant and audit-ready.
Facilitate risk analysis and process modeling white-board sessions with direct reports team to develop cross-functional support processes.
Define the approach and provide oversight for the Corp. IT GxP Training efforts.
Ensure compliance with all GxP regulations, including GMP, GCP, and GLP, across all our IT systems and processes.
Ensure policies, procedures, and best practices to maintain the highest standards of compliance.
Provide strategic direction and leadership fostering a culture of continuous improvement and excellence.
Ensure timely and effective communication with all collaborators, including senior management, regulatory authorities, and cross-functional teams.
Monitor and assess the impact of new regulations and guidelines and implement needed changes to maintain compliance.
Applying practical experience of IT Risk Management Methodology to Computer Systems Validation (CSV) and Computer Systems Assurance (CSA) models.
Manage the budget and resources, ensuring efficient and effective use of resources.
Oversee IT quality incident investigations, including input and approval of plans for resolution of issues. Partner with collaborators to ensure CAPAs are appropriate and effective.
Manage and develop Quality Assurance personnel, including recruitment, performance management, hiring, training and development.
This may be for you if you:
* Want to be entrusted to support all IT compliance aspects of our science from conceptualization through manufacturing.
* Possess experiences to inspire others within your organization
* Have worked in a rapid response environment.
* Ability to think strategically and drive continuous improvement initiatives.
* Strong problem-solving skills ensuring sound decisions under pressure.
* Meticulous with a solid focus on quality and compliance.
To be considered for this role, you must have: Bachelor's degree in Information Technology, Computer Science, Life Sciences, or a related field along with 12+ years of experience in IT quality assurance and compliance within the biopharmaceutical industry. An advanced degree is preferred. Strong leadership and management skills, with experience in leading and developing high-performing teams. Strong communication and presentation skills.
Additional requirements:
* Extensive knowledge of GxP regulations, including GMP, GCP, and GLP
* Managing IT responsibilities for Health Authority and internal company audits. The ability to review, assess and defend critical audit observations where applicable.
* Ability to train staff in accordance with regulatory and company standards is critical.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$180,400.00 - $300,700.00
Director, Omnichannel Marketing
Remote or Princeton, NJ Job
The Role
As the Director, Omnichannel Strategy, you will play a pivotal role in shaping Moderna's approach to customer engagement by developing and executing a comprehensive omnichannel strategy. This role will lead the integration of digital, retail, and field channels, creating seamless, data-driven experiences that enhance the customer journey for healthcare professionals and key opinion leaders. In this position, you will optimize touchpoints across all channels, ensuring consistent messaging and alignment with our broader commercial and medical marketing goals. Through close collaboration with cross-functional teams, you will champion best-in-class marketing technologies, elevating Moderna's ability to engage with healthcare stakeholders in a dynamic, regulated environment. Your leadership will drive customer loyalty and enhance Moderna's market performance, positioning the company as a trusted partner to healthcare professionals worldwide.
Here's What You'll Do
Lead the design, development, and execution of omnichannel marketing strategies to enhance customer engagement and drive awareness, access, and uptake of vaccines.
Align channel strategy with broader marketing goals by identifying an optimal mix of digital, in-person, and traditional channels to effectively reach target audiences, including healthcare providers, patients, health systems, and retail pharmacies.
Partner closely with cross-functional teams such as Sales, Medical, Digital, Integrated Media and Analytics to integrate omnichannel approaches into marketing plans, ensuring a seamless and consistent experience across customer touchpoints.
Oversee customer segmentation strategies, using data insights to tailor messaging and engagement methods based on specific audience needs (e.g., regional health systems, IDNs, retail channels, public health agencies).
Implement personalization at scale by leveraging advanced tools and technologies to deliver targeted, relevant content that resonates with specific demographics and customer preferences.
Drive data-informed decision-making, utilizing analytics to measure channel effectiveness, optimize content delivery, and refine strategies based on performance insights, customer behaviors, and engagement metrics.
Collaborate with the analytics team to develop dashboards and reporting frameworks that monitor key KPIs, including engagement rates, campaign ROI, and customer journey insights.
Champion the adoption of digital platforms and emerging technologies to maximize omnichannel effectiveness, including CRM, marketing automation, content management systems, and AI-driven tools.
Work alongside IT and digital teams to ensure integration and smooth functioning of technology systems supporting marketing activities, such as real-time data tracking, automated customer insights, and digital campaign execution.
Serve as a central collaboration point across US Commercial teams, aligning omnichannel efforts with broader marketing, medical, and sales initiatives.
Engage with Global Marketing counterparts to maintain brand consistency and share best practices, especially in adapting global strategies to suit the US market.
Build relationships with external partners, including digital agencies, retail pharmacy chains, healthcare organizations, and public health agencies, to expand the reach and impact of Moderna's omnichannel marketing.
Strengthen partnerships with regional and local health systems to support local and regional vaccination initiatives through the omnichannel approach.
Ensure all omnichannel activities comply with regulatory standards and company policies, collaborating with Legal and Compliance teams to navigate the complexities of vaccine marketing across various channels.
Develop guidelines and best practices that prioritize patient safety and data privacy, ensuring alignment with regulatory standards.
Here's What You'll Need (Minimum Qualifications)
Bachelor's Degree in Marketing, Business Administration, Communications, or a related field is required.
Master's Degree (MBA or MPH) in Marketing, Business, Public Health, or a related field is highly preferred, especially for candidates transitioning into the biopharma or vaccine space from other industries.
8-10+ years of marketing experience within the pharmaceutical, biotech, or healthcare industries, with a minimum of 3-5 years specifically focused on omnichannel or digital marketing strategy.
Here's What You'll Bring to the Table (Preferred Qualifications)
Proven expertise in developing and executing data-driven marketing strategies that span multiple channels, including digital, in-person, and traditional mediums.
Strong understanding of healthcare industry regulations, with the ability to navigate compliance requirements in highly regulated environments.
Experience with advanced marketing technologies and tools, such as CRM, marketing automation, content management systems, and AI-driven analytics.
Demonstrated ability to work collaboratively with cross-functional teams (e.g., Sales, Medical, Digital, Analytics) to drive customer-centric marketing solutions.
Exceptional analytical skills, with a track record of using data insights to inform and adjust marketing strategies.
Effective communication and stakeholder management skills, with experience working with external partners such as digital agencies, healthcare organizations, and public health agencies.
A forward-thinking approach to marketing, with a desire to innovate and apply new techniques that enhance Moderna's engagement with healthcare stakeholders.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
This role is expected to be in office 70% of the time with flexibility to work from home up to 30%.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community
Generous paid time off, including:
• Vacation, sick time and holidays
• Volunteer time to participate within your community
• Discretionary year-end shutdown
• Paid sabbatical after 5 years; every 3 years thereafter
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras!
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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Oncology Regional Medical Scientific Director - Thoracic Malignancies - Southern CA (Remote)
Remote or Los Angeles, CA Job
Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio.
The Oncology Regional Medical Scientific Director, RMSD, is a credentialed (i.e., MD, PhD, or PharmD) therapeutic and disease expert who engages in scientific exchange with leaders in the external medical and scientific community. Scientific exchange does not include promotional claims about any drug, vaccine or biologic product. RMSDs provide to Scientific Leaders (SLs) balanced, factual, scientific information about non-product areas of interest to the company. The RMSD provides research support to our Investigator-Sponsored and Company-Sponsored Trials to enhance the understanding of the scientific foundations and goals of the study, support patient enrollment and retention efforts for a given study or address Investigator questions. RMSDs also respond to scientific questions from SLs, including questions about company products. RMSDs have no sales objectives or accountability for prescribing or sales of any company product and are required to avoid any situations that could create the appearance that they have such responsibilities. An RMSD may not comment on or make suggestions with respect to the diagnosis, treatment, or circumstances of a specific patient.
**Location:**
+ This position covers the territory of southern CA, primarily Los Angeles, but will exclude San Diego. **Applicants must** **reside within the assigned territory.**
+ Up to 50% travel required with some overnight.
**Primary Responsibilities**
+ Develop professional relationships and communicate with national and regional scientific leaders to ensure access to medical and scientific information on areas of therapeutic interest and company products.
+ Conduct peer to peer scientific discussions and maintain a reliable presence with those scientific leaders to ensure they have a medical contact within the company.
+ Upon request from Global Clinical Trial Operations (GCTO), support Company-Sponsored Trials to enhance the understanding of scientific foundations and goals of the study, support patient enrollment and retention efforts or address investigator questions.
+ May initiate discussion with potential investigators to determine the level of interest and qualifications for a specific compound or trial.
+ Recommend potential study sites to Global Clinical Trial Operations (GCTO)/Clinical Research.
+ Address requests from investigators for information regarding participation in our Research and Development Division's studies.
+ Address scientific questions.
+ Studies to enhance the understanding of the scientific foundations and goals of the study, support patient enrollment and retention efforts or address investigator questions.
+ Investigator-Sponsored upon request from Global Center for Scientific Affairs (GCSA), support company
+ Share the company's " areas of interest' and discuss study concepts to assess scientific merit and alignment with the company's research strategies.
+ Respond to unsolicited requests for assistance from potential investigators in submitting research proposals by providing internal guidelines or technical and scientific advice.
+ Education and training to maintain current knowledge and understanding of dynamic scientific and clinical environment in the company's areas of interest.
+ Direct scientific leader inquiries on issues outside of RMSD scope of responsibilities (e.g., grants) to appropriate company resources consistent with applicable policies.
+ When requested by our Research and Development Division, serve as a resource for the identification of potential investigators for consideration for participating in phase II-IV clinical development programs
+ In response to unsolicited requests from scientific leaders, provide areas of interest and general high-level information regarding the company Investigator Study Program process.
+ Serve as a role model for other field medical team members, including on-boarding and/or therapeutic training partner.
+ Attend scientific and medical meetings.
**Education Minimum Requirement**
+ PhD, Pharm.D, MD, DNP
**Required Experience and Skills**
+ Clinical (patient care) or deep research experience in assigned therapeutic area(s) beyond that obtained in the terminal degree program.
+ A minimum of 3 years' experience and proven therapeutic competence in the oncology.
+ Capable of conducting doctoral level discussions with key external stakeholders
+ Strong focus on scientific education and dialogue
+ Business and market knowledge, including quality management.
+ Excellent interpersonal, communication, and networking skills
+ Must possess a thorough understanding of the United States Federal Drug Administration (FDA), Office of Inspector General (OIG), Health Insurance Portability and Accountability Act (HIPAA) and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry and its customers.
+ Must be able to organize, prioritize, and work effectively in a constantly changing environment.
+ Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Access).
**Preferred Experience and Skills**
+ Field-based medical experience
+ Clinical research experience
+ Demonstrated record of scientific/medical publication
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
Pay Transparency Nondiscrimination (***********************************************************************************************
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$206,200.00 - $324,600.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (********************************* .
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
50%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
02/11/2025
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R330273
Technical Applications Specialist (Remote) (283872)
Remote or Burlington, MA Job
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
You should have strong experience in downstream purification operations, with an emphasis on Clarification and Tangential Flow Filtration. The position will work with the local Commercial team members to support sales opportunities in the Midwest United States & Eastern Canada. As part of this team, you will leverage your expertise and strategic insights in the field of downstream technologies including filtration and purification portfolios to effectively collaborate with commercial partners and drive sales. Use your understanding of customers, current industry drivers and trends, together with an appreciation of competition dynamics to effectively identify strategic opportunities to gain market share and grow the business. You will also bring customer and commercial feed-back to leadership, business, & strategy to share best practices and identify potential gaps.
Travel Requirement: 30% visiting customer locations within US and Eastern Canada (best if located in the mid-west (Chicago, MN)
Who You Are
Minimum Qualifications:
Bachelor of Science degree in a scientific or engineering discipline or other scientific discipline
1 + years of hands-on downstream purification experience in the biopharma industry
1+ years of experience working with development of TFF and/or Clarification purification unit operations
Preferred Qualifications
Strong customer and sales orientation
Demonstrated ability to establish partnerships
The ability to communicate clearly, concisely, and effectively to diverse audiences through both written and oral communications
Graduate degree science or engineering degree and / or a Master of Business Administration
5+ years direct experience with development and implementation of purification unit operations, ideally as a Process Development Scientist
Demonstrated ability to establish strong partnerships with internal and external partners
Experience working in a sales or marketing organization
Demonstrated ability to communicate clearly, concisely, and effectively to diverse audiences through both written and oral communications
Pay Range for this position - $70,000 - $120,000/year
Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k)-matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit ********************************************************
Senior Director-Epidemiology/HEOR
Remote Job
As a Senior Director, HEOR you will be responsible for leading HEOR-Epidemiology activities to inform, support, and strengthen global development and commercialization activities for our products within our General Medical area. Drawing on your expertise in epidemiologic study design and methods as well as on your knowledge of real-world data, you will design, conduct, and reporting of real-world evidence (RWE) studies. It is expected to have current epidemiologic methods and work effectively in a cross-functional environment.
This is a Sleepy Hollow, NY office-based position with requirements to be on-site for a minimum of 3 days/week. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option for this position.
A typical day may include the following:
• Conducting observational research, using large electronic healthcare databases to generate a better understanding of disease and real-world outcomes
• Developing and/or reviewing protocols and statistical analysis plans for studies assessing the natural history of disease, burden of illness, treatment patterns, healthcare resource utilization/costs, and effectiveness of treatments
• Critically reviewing the literature and querying real-world data to estimate the incidence and prevalence of disease
• Authoring epidemiology sections of regulatory documents (e.g., orphan drug designation, diversity plans, etc.)
• Working cross-functionally with medical affairs, clinical development, regulatory affairs, pharmacoepidemiology
• Collaborating with HEOR colleagues and other internal partners to disseminate RWE in compliance with company, industry, and regulatory requirements
• Maintaining an up-to-date awareness of guidance documents and communications that may impact RWE strategies and RWE generation
• Contributing to the advancement of the field of RWE/epidemiology by publishing high-quality research in leading journals, speaking publicly at scientific conferences, and serving as a peer-reviewer
This may be for you if:
• Can influence epidemiology strategy for internal and external audiences.
• Want to work for a highly accomplished team who strive for excellence.
• Thrive working in a “rapid response” environment.
• Want to have an impact on patient lives
To be considered you are required to have a Ph.D. in epidemiology, public health, health services research or related field with 10+ years of academic, pharma/biotech, or consulting experience with a focus. Experience in drug development is required. Any experience in cardiovascular, ophthalmology, rare diseases, immunology, infectious diseases or oncology is preferred.
Required experience includes:
• Designing and drafting study protocols and statistical analysis plans using real-world data (e.g. administrative claims data, EMRs, registries) with a record of publications in peer-reviewed journals;
• Advanced knowledge of statistical methods commonly used in the analysis of large electronic healthcare databases (e.g. survival analysis, propensity scores); knowledge of machine learning is a plus
• Excellent written and verbal communication skills
• Ability to work cross-functionally and present to internal partners, including senior management.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$233,700.00 - $389,500.00
Manager, Medical Study Operations
Remote or Sleepy Hollow, NY Job
As a Manager, Medical Study Operations you will be responsible for all operational aspects of multiple projects/programs such as the Compassionate Use Programs, Investigator-Initiated (IIS) Studies Program, Collaboration Studies. This is an on-site position will require you to be on-site 3+ days/week at our Sleepy Hollow, NY location. We cannot offer a fully remote option. If eligible, we can offer relocation benefits.
A typical day may include the following:
Operational responsibility across programs within Compassionate Use, Expanded Access Programs, IIS, Pre-Clinical Collaborations, Sample Analysis Studies, Collaboration studies, Data Transparency
Participating in team review meetings, product team alignment meetings, and program budget & status update meetings as needed.
Accountable for financial forecasting accuracy of studies within span of responsibility.
Maintenance of program budget trackers, ensuring communicated actuals and accruals are captured, projections are re-forecasted as necessary, and brand give back are fully assessed.
Maintains financial forecast for programs for quarterly for reporting to Accounting & Finance, and responsible for ensuring issue resolution for all discrepancies.
Managing drug supply for Compassionate Use and IIS programs, as appropriate.
Ongoing analyses, tracking and reporting of projects/programs support, timelines for completion, expected or assessed delays.
Participating in solutions for streamlining processes for greater efficiency, and other related metrics in support of program activities.
Manages vendors and financial tracking as required per program.
Ensuring appropriate archiving of projects'/programs' essential documents.
Uses appropriate systems to contribute to cross-functional communication, planning and transparency.
Ensuring ongoing QC of SharePoint document storage for completeness and audit readiness.
Utilization of QlikSense, QlikView, SharePoint, Oracle and ERRS portal to support team needs.
Adheres to all relevant processes, trainings, and SOPS to ensure consistency, efficiency, and compliance.
Continued process improvements ensuring consistency, efficiency, and compliance.
This may be for you if you:
* Want to have an impact on patient lives.
* Can work effectively in a rapid-response environment.
* Enjoy collaborating with different partners (clinical, pre-clinical, commercial, external customers)
* Want to make a difference in developing processes and systems.
To be considered a bachelor's degree is required and an advanced degree preferred. You are to have 5+ years' experience working in clinical research or medical operations within the pharmaceutical or biotech industry. Active working experience and/or courses pertaining to clinical research and/or MA areas (such as GCP, Investigator Initiated Studies; medical/educational grants administration; medical information; registries; OIG/PhRMA guidance.).
Preferred experiences:
* Compassionate Use or Managed Access programs
* A science background with active experience in the areas of inflammation/immunology/antibody research.
* Working within or supporting Medical Affairs
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$110,900.00 - $181,100.00
Oncology Regional Medical Scientific Director - Thoracic Malignancies - Southern CA (Remote)
Remote or Juneau, AK Job
Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio.
The Oncology Regional Medical Scientific Director, RMSD, is a credentialed (i.e., MD, PhD, or PharmD) therapeutic and disease expert who engages in scientific exchange with leaders in the external medical and scientific community. Scientific exchange does not include promotional claims about any drug, vaccine or biologic product. RMSDs provide to Scientific Leaders (SLs) balanced, factual, scientific information about non-product areas of interest to the company. The RMSD provides research support to our Investigator-Sponsored and Company-Sponsored Trials to enhance the understanding of the scientific foundations and goals of the study, support patient enrollment and retention efforts for a given study or address Investigator questions. RMSDs also respond to scientific questions from SLs, including questions about company products. RMSDs have no sales objectives or accountability for prescribing or sales of any company product and are required to avoid any situations that could create the appearance that they have such responsibilities. An RMSD may not comment on or make suggestions with respect to the diagnosis, treatment, or circumstances of a specific patient.
**Location:**
+ This position covers the territory of southern CA, primarily Los Angeles, but will exclude San Diego. **Applicants must** **reside within the assigned territory.**
+ Up to 50% travel required with some overnight.
**Primary Responsibilities**
+ Develop professional relationships and communicate with national and regional scientific leaders to ensure access to medical and scientific information on areas of therapeutic interest and company products.
+ Conduct peer to peer scientific discussions and maintain a reliable presence with those scientific leaders to ensure they have a medical contact within the company.
+ Upon request from Global Clinical Trial Operations (GCTO), support Company-Sponsored Trials to enhance the understanding of scientific foundations and goals of the study, support patient enrollment and retention efforts or address investigator questions.
+ May initiate discussion with potential investigators to determine the level of interest and qualifications for a specific compound or trial.
+ Recommend potential study sites to Global Clinical Trial Operations (GCTO)/Clinical Research.
+ Address requests from investigators for information regarding participation in our Research and Development Division's studies.
+ Address scientific questions.
+ Studies to enhance the understanding of the scientific foundations and goals of the study, support patient enrollment and retention efforts or address investigator questions.
+ Investigator-Sponsored upon request from Global Center for Scientific Affairs (GCSA), support company
+ Share the company's " areas of interest' and discuss study concepts to assess scientific merit and alignment with the company's research strategies.
+ Respond to unsolicited requests for assistance from potential investigators in submitting research proposals by providing internal guidelines or technical and scientific advice.
+ Education and training to maintain current knowledge and understanding of dynamic scientific and clinical environment in the company's areas of interest.
+ Direct scientific leader inquiries on issues outside of RMSD scope of responsibilities (e.g., grants) to appropriate company resources consistent with applicable policies.
+ When requested by our Research and Development Division, serve as a resource for the identification of potential investigators for consideration for participating in phase II-IV clinical development programs
+ In response to unsolicited requests from scientific leaders, provide areas of interest and general high-level information regarding the company Investigator Study Program process.
+ Serve as a role model for other field medical team members, including on-boarding and/or therapeutic training partner.
+ Attend scientific and medical meetings.
**Education Minimum Requirement**
+ PhD, Pharm.D, MD, DNP
**Required Experience and Skills**
+ Clinical (patient care) or deep research experience in assigned therapeutic area(s) beyond that obtained in the terminal degree program.
+ A minimum of 3 years' experience and proven therapeutic competence in the oncology.
+ Capable of conducting doctoral level discussions with key external stakeholders
+ Strong focus on scientific education and dialogue
+ Business and market knowledge, including quality management.
+ Excellent interpersonal, communication, and networking skills
+ Must possess a thorough understanding of the United States Federal Drug Administration (FDA), Office of Inspector General (OIG), Health Insurance Portability and Accountability Act (HIPAA) and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry and its customers.
+ Must be able to organize, prioritize, and work effectively in a constantly changing environment.
+ Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Access).
**Preferred Experience and Skills**
+ Field-based medical experience
+ Clinical research experience
+ Demonstrated record of scientific/medical publication
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
Pay Transparency Nondiscrimination (***********************************************************************************************
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$206,200.00 - $324,600.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (********************************* .
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
50%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
02/11/2025
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R330273
Director IT Quality Assurance & Compliance
Remote or Ridgefield, NJ Job
As a Director of IT, Quality Assurance and Compliance you will lead and manage a team, consisting of 20 to 30 members, including direct reports. The focus of this role is to provide leadership, coaching, and technical support to the Corporate IT QA & Compliance Management Team, the supporting IT and business functions, and Managed Service Providers. We provide regulatory compliance support and services continuing to advance the principles of regulatory compliance throughout the IT organization.
This is an on-site position for 3+ days/week at our Sleepy Hollow, NY or Basking Ridge, NJ office. If eligible, we can offer relocation benefits. We cannot offer a fully remote option.
A typical day may include the following:
Collaborate with Manufacturing, Research and Clinical Studies QA teams to ensure seamless integration of IT quality assurance practices.
Oversee the preparation and management of our Health Authority and internal company audits. Ensures all IT-related aspects are compliant and audit-ready.
Facilitate risk analysis and process modeling white-board sessions with direct reports team to develop cross-functional support processes.
Define the approach and provide oversight for the Corp. IT GxP Training efforts.
Ensure compliance with all GxP regulations, including GMP, GCP, and GLP, across all our IT systems and processes.
Ensure policies, procedures, and best practices to maintain the highest standards of compliance.
Provide strategic direction and leadership fostering a culture of continuous improvement and excellence.
Ensure timely and effective communication with all collaborators, including senior management, regulatory authorities, and cross-functional teams.
Monitor and assess the impact of new regulations and guidelines and implement needed changes to maintain compliance.
Applying practical experience of IT Risk Management Methodology to Computer Systems Validation (CSV) and Computer Systems Assurance (CSA) models.
Manage the budget and resources, ensuring efficient and effective use of resources.
Oversee IT quality incident investigations, including input and approval of plans for resolution of issues. Partner with collaborators to ensure CAPAs are appropriate and effective.
Manage and develop Quality Assurance personnel, including recruitment, performance management, hiring, training and development.
This may be for you if you:
• Want to be entrusted to support all IT compliance aspects of our science from conceptualization through manufacturing.
• Possess experiences to inspire others within your organization
• Have worked in a rapid response environment.
• Ability to think strategically and drive continuous improvement initiatives.
• Strong problem-solving skills ensuring sound decisions under pressure.
• Meticulous with a solid focus on quality and compliance.
To be considered for this role, you must have: Bachelor's degree in Information Technology, Computer Science, Life Sciences, or a related field along with 12+ years of experience in IT quality assurance and compliance within the biopharmaceutical industry. An advanced degree is preferred. Strong leadership and management skills, with experience in leading and developing high-performing teams. Strong communication and presentation skills.
Additional requirements:
• Extensive knowledge of GxP regulations, including GMP, GCP, and GLP
• Managing IT responsibilities for Health Authority and internal company audits. The ability to review, assess and defend critical audit observations where applicable.
• Ability to train staff in accordance with regulatory and company standards is critical.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$180,400.00 - $300,700.00
Director, Omnichannel Marketing
Remote or Princeton, NJ Job
The Role
As the Director, Omnichannel Strategy, you will play a pivotal role in shaping Moderna's approach to customer engagement by developing and executing a comprehensive omnichannel strategy. This role will lead the integration of digital, retail, and field channels, creating seamless, data-driven experiences that enhance the customer journey for healthcare professionals and key opinion leaders. In this position, you will optimize touchpoints across all channels, ensuring consistent messaging and alignment with our broader commercial and medical marketing goals. Through close collaboration with cross-functional teams, you will champion best-in-class marketing technologies, elevating Moderna's ability to engage with healthcare stakeholders in a dynamic, regulated environment. Your leadership will drive customer loyalty and enhance Moderna's market performance, positioning the company as a trusted partner to healthcare professionals worldwide.
Here's What You'll Do
Lead the design, development, and execution of omnichannel marketing strategies to enhance customer engagement and drive awareness, access, and uptake of vaccines.
Align channel strategy with broader marketing goals by identifying an optimal mix of digital, in-person, and traditional channels to effectively reach target audiences, including healthcare providers, patients, health systems, and retail pharmacies.
Partner closely with cross-functional teams such as Sales, Medical, Digital, Integrated Media and Analytics to integrate omnichannel approaches into marketing plans, ensuring a seamless and consistent experience across customer touchpoints.
Oversee customer segmentation strategies, using data insights to tailor messaging and engagement methods based on specific audience needs (e.g., regional health systems, IDNs, retail channels, public health agencies).
Implement personalization at scale by leveraging advanced tools and technologies to deliver targeted, relevant content that resonates with specific demographics and customer preferences.
Drive data-informed decision-making, utilizing analytics to measure channel effectiveness, optimize content delivery, and refine strategies based on performance insights, customer behaviors, and engagement metrics.
Collaborate with the analytics team to develop dashboards and reporting frameworks that monitor key KPIs, including engagement rates, campaign ROI, and customer journey insights.
Champion the adoption of digital platforms and emerging technologies to maximize omnichannel effectiveness, including CRM, marketing automation, content management systems, and AI-driven tools.
Work alongside IT and digital teams to ensure integration and smooth functioning of technology systems supporting marketing activities, such as real-time data tracking, automated customer insights, and digital campaign execution.
Serve as a central collaboration point across US Commercial teams, aligning omnichannel efforts with broader marketing, medical, and sales initiatives.
Engage with Global Marketing counterparts to maintain brand consistency and share best practices, especially in adapting global strategies to suit the US market.
Build relationships with external partners, including digital agencies, retail pharmacy chains, healthcare organizations, and public health agencies, to expand the reach and impact of Moderna's omnichannel marketing.
Strengthen partnerships with regional and local health systems to support local and regional vaccination initiatives through the omnichannel approach.
Ensure all omnichannel activities comply with regulatory standards and company policies, collaborating with Legal and Compliance teams to navigate the complexities of vaccine marketing across various channels.
Develop guidelines and best practices that prioritize patient safety and data privacy, ensuring alignment with regulatory standards.
Here's What You'll Need (Minimum Qualifications)
Bachelor's Degree in Marketing, Business Administration, Communications, or a related field is required.
Master's Degree (MBA or MPH) in Marketing, Business, Public Health, or a related field is highly preferred, especially for candidates transitioning into the biopharma or vaccine space from other industries.
8-10+ years of marketing experience within the pharmaceutical, biotech, or healthcare industries, with a minimum of 3-5 years specifically focused on omnichannel or digital marketing strategy.
Here's What You'll Bring to the Table (Preferred Qualifications)
Proven expertise in developing and executing data-driven marketing strategies that span multiple channels, including digital, in-person, and traditional mediums.
Strong understanding of healthcare industry regulations, with the ability to navigate compliance requirements in highly regulated environments.
Experience with advanced marketing technologies and tools, such as CRM, marketing automation, content management systems, and AI-driven analytics.
Demonstrated ability to work collaboratively with cross-functional teams (e.g., Sales, Medical, Digital, Analytics) to drive customer-centric marketing solutions.
Exceptional analytical skills, with a track record of using data insights to inform and adjust marketing strategies.
Effective communication and stakeholder management skills, with experience working with external partners such as digital agencies, healthcare organizations, and public health agencies.
A forward-thinking approach to marketing, with a desire to innovate and apply new techniques that enhance Moderna's engagement with healthcare stakeholders.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
This role is expected to be in office 70% of the time with flexibility to work from home up to 30%.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community
Generous paid time off, including:
• Vacation, sick time and holidays
• Volunteer time to participate within your community
• Discretionary year-end shutdown
• Paid sabbatical after 5 years; every 3 years thereafter
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras!
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
-
Senior Director-Epidemiology/HEOR
Remote or Sleepy Hollow, NY Job
As a Senior Director, HEOR you will be responsible for leading HEOR-Epidemiology activities to inform, support, and strengthen global development and commercialization activities for our products within our General Medical area. Drawing on your expertise in epidemiologic study design and methods as well as on your knowledge of real-world data, you will design, conduct, and reporting of real-world evidence (RWE) studies. It is expected to have current epidemiologic methods and work effectively in a cross-functional environment.
This is a Sleepy Hollow, NY office-based position with requirements to be on-site for a minimum of 3 days/week. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option for this position.
A typical day may include the following:
* Conducting observational research, using large electronic healthcare databases to generate a better understanding of disease and real-world outcomes
* Developing and/or reviewing protocols and statistical analysis plans for studies assessing the natural history of disease, burden of illness, treatment patterns, healthcare resource utilization/costs, and effectiveness of treatments
* Critically reviewing the literature and querying real-world data to estimate the incidence and prevalence of disease
* Authoring epidemiology sections of regulatory documents (e.g., orphan drug designation, diversity plans, etc.)
* Working cross-functionally with medical affairs, clinical development, regulatory affairs, pharmacoepidemiology
* Collaborating with HEOR colleagues and other internal partners to disseminate RWE in compliance with company, industry, and regulatory requirements
* Maintaining an up-to-date awareness of guidance documents and communications that may impact RWE strategies and RWE generation
* Contributing to the advancement of the field of RWE/epidemiology by publishing high-quality research in leading journals, speaking publicly at scientific conferences, and serving as a peer-reviewer
This may be for you if:
* Can influence epidemiology strategy for internal and external audiences.
* Want to work for a highly accomplished team who strive for excellence.
* Thrive working in a "rapid response" environment.
* Want to have an impact on patient lives
To be considered you are required to have a Ph.D. in epidemiology, public health, health services research or related field with 10+ years of academic, pharma/biotech, or consulting experience with a focus. Experience in drug development is required. Any experience in cardiovascular, ophthalmology, rare diseases, immunology, infectious diseases or oncology is preferred.
Required experience includes:
* Designing and drafting study protocols and statistical analysis plans using real-world data (e.g. administrative claims data, EMRs, registries) with a record of publications in peer-reviewed journals;
* Advanced knowledge of statistical methods commonly used in the analysis of large electronic healthcare databases (e.g. survival analysis, propensity scores); knowledge of machine learning is a plus
* Excellent written and verbal communication skills
* Ability to work cross-functionally and present to internal partners, including senior management.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$233,700.00 - $389,500.00
Oncology Regional Medical Scientific Director - Thoracic Malignancies - Southern CA (Remote)
Remote or Madison, WI Job
Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio.
The Oncology Regional Medical Scientific Director, RMSD, is a credentialed (i.e., MD, PhD, or PharmD) therapeutic and disease expert who engages in scientific exchange with leaders in the external medical and scientific community. Scientific exchange does not include promotional claims about any drug, vaccine or biologic product. RMSDs provide to Scientific Leaders (SLs) balanced, factual, scientific information about non-product areas of interest to the company. The RMSD provides research support to our Investigator-Sponsored and Company-Sponsored Trials to enhance the understanding of the scientific foundations and goals of the study, support patient enrollment and retention efforts for a given study or address Investigator questions. RMSDs also respond to scientific questions from SLs, including questions about company products. RMSDs have no sales objectives or accountability for prescribing or sales of any company product and are required to avoid any situations that could create the appearance that they have such responsibilities. An RMSD may not comment on or make suggestions with respect to the diagnosis, treatment, or circumstances of a specific patient.
**Location:**
+ This position covers the territory of southern CA, primarily Los Angeles, but will exclude San Diego. **Applicants must** **reside within the assigned territory.**
+ Up to 50% travel required with some overnight.
**Primary Responsibilities**
+ Develop professional relationships and communicate with national and regional scientific leaders to ensure access to medical and scientific information on areas of therapeutic interest and company products.
+ Conduct peer to peer scientific discussions and maintain a reliable presence with those scientific leaders to ensure they have a medical contact within the company.
+ Upon request from Global Clinical Trial Operations (GCTO), support Company-Sponsored Trials to enhance the understanding of scientific foundations and goals of the study, support patient enrollment and retention efforts or address investigator questions.
+ May initiate discussion with potential investigators to determine the level of interest and qualifications for a specific compound or trial.
+ Recommend potential study sites to Global Clinical Trial Operations (GCTO)/Clinical Research.
+ Address requests from investigators for information regarding participation in our Research and Development Division's studies.
+ Address scientific questions.
+ Studies to enhance the understanding of the scientific foundations and goals of the study, support patient enrollment and retention efforts or address investigator questions.
+ Investigator-Sponsored upon request from Global Center for Scientific Affairs (GCSA), support company
+ Share the company's " areas of interest' and discuss study concepts to assess scientific merit and alignment with the company's research strategies.
+ Respond to unsolicited requests for assistance from potential investigators in submitting research proposals by providing internal guidelines or technical and scientific advice.
+ Education and training to maintain current knowledge and understanding of dynamic scientific and clinical environment in the company's areas of interest.
+ Direct scientific leader inquiries on issues outside of RMSD scope of responsibilities (e.g., grants) to appropriate company resources consistent with applicable policies.
+ When requested by our Research and Development Division, serve as a resource for the identification of potential investigators for consideration for participating in phase II-IV clinical development programs
+ In response to unsolicited requests from scientific leaders, provide areas of interest and general high-level information regarding the company Investigator Study Program process.
+ Serve as a role model for other field medical team members, including on-boarding and/or therapeutic training partner.
+ Attend scientific and medical meetings.
**Education Minimum Requirement**
+ PhD, Pharm.D, MD, DNP
**Required Experience and Skills**
+ Clinical (patient care) or deep research experience in assigned therapeutic area(s) beyond that obtained in the terminal degree program.
+ A minimum of 3 years' experience and proven therapeutic competence in the oncology.
+ Capable of conducting doctoral level discussions with key external stakeholders
+ Strong focus on scientific education and dialogue
+ Business and market knowledge, including quality management.
+ Excellent interpersonal, communication, and networking skills
+ Must possess a thorough understanding of the United States Federal Drug Administration (FDA), Office of Inspector General (OIG), Health Insurance Portability and Accountability Act (HIPAA) and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry and its customers.
+ Must be able to organize, prioritize, and work effectively in a constantly changing environment.
+ Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Access).
**Preferred Experience and Skills**
+ Field-based medical experience
+ Clinical research experience
+ Demonstrated record of scientific/medical publication
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
Pay Transparency Nondiscrimination (***********************************************************************************************
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$206,200.00 - $324,600.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (********************************* .
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
50%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
02/11/2025
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R330273
Associate Director, Field Medical Affairs-Hematology (Florida)
Remote Job
As an Associate Director, Field Medical Affairs (Medical Science Liaison) you will engage in the exchange of our scientific data and medical information with KOLs, HCPs, researchers, pharmacists and population-based decision makers. We are expected to demonstrate a thorough understanding of B-Cell Malignancies (NHL and Multiple Myeloma) aligned with our strategic medical plans.
Territory: Florida
A typical day may include the following:
Identifying and maintaining a list of medical/therapeutic area experts, investigator targets and associated plans of action.
Establishing, fostering, cultivating and maintaining relationships with KOLs in Hematological Malignancies
Act as the primary clinical/scientific resource for information pertaining to disease state and our products ensuring awareness and understanding.
Participates in the development and management of company sponsored clinical trials including.
Establishing scientific relationship with investigators and internal Medical Affairs, supporting investigator-initiated study (IIS) concept program.
Identifying relevant insights on research developments, treatment landscape to shape medical strategy
Identifies gaps in research needs and creates opportunities by collaborating with potential and existing investigators and site personnel.
Responds to requests for information related to study indications, disease state and therapeutic area, and presents/discusses scientific/clinical data.
Attends medical conferences collecting and reporting relevant, scientific, clinical, & competitive intelligence.
Ensures company policies, procedures, principles and financial controls are maintained with integrity and professionalism is displayed internally and externally
This may be for you if you:
Want to be a part of a pre-launch stage team potentially for multiple launches.
Are skilled in the art of strategic conversation along with a proven ability to assess issues adapting appropriately.
Can demonstrate an understanding of “know your audience” and ability to tailor information appropriately.
Have demonstrated the ability to anticipate, organize, plan and handle multiple priorities, while adapting to the needs of the company.
To be considered a terminal scientific degree (MD, PharmD, or PhD) is required. 8+ years of experience with a minimum of 4 years experience within a Hematology/Oncology Medical Science Liaison function is required. Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines.
Additional requirements:
• Residency in the assigned territory
• Travel: Capable of engaging in frequent business travel (approximately 70% of time), including air travel, overnight and occasionally on weekends.
• Possesses and maintains a valid driver's license and clean driving record.
Preferred experiences include:
• Established relationships with KOLs and institutions focused on Hematologic Malignancies
• Drug launch experience.
#msl #medicalscienceliasion #hematology
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$173,500.00 - $283,100.00
Director IT Quality Assurance & Compliance
Remote or Sleepy Hollow, NY Job
As a Director of IT, Quality Assurance and Compliance you will lead and manage a team, consisting of 20 to 30 members, including direct reports. The focus of this role is to provide leadership, coaching, and technical support to the Corporate IT QA & Compliance Management Team, the supporting IT and business functions, and Managed Service Providers. We provide regulatory compliance support and services continuing to advance the principles of regulatory compliance throughout the IT organization.
This is an on-site position for 3+ days/week at our Sleepy Hollow, NY or Basking Ridge, NJ office. If eligible, we can offer relocation benefits. We cannot offer a fully remote option.
A typical day may include the following:
Collaborate with Manufacturing, Research and Clinical Studies QA teams to ensure seamless integration of IT quality assurance practices.
Oversee the preparation and management of our Health Authority and internal company audits. Ensures all IT-related aspects are compliant and audit-ready.
Facilitate risk analysis and process modeling white-board sessions with direct reports team to develop cross-functional support processes.
Define the approach and provide oversight for the Corp. IT GxP Training efforts.
Ensure compliance with all GxP regulations, including GMP, GCP, and GLP, across all our IT systems and processes.
Ensure policies, procedures, and best practices to maintain the highest standards of compliance.
Provide strategic direction and leadership fostering a culture of continuous improvement and excellence.
Ensure timely and effective communication with all collaborators, including senior management, regulatory authorities, and cross-functional teams.
Monitor and assess the impact of new regulations and guidelines and implement needed changes to maintain compliance.
Applying practical experience of IT Risk Management Methodology to Computer Systems Validation (CSV) and Computer Systems Assurance (CSA) models.
Manage the budget and resources, ensuring efficient and effective use of resources.
Oversee IT quality incident investigations, including input and approval of plans for resolution of issues. Partner with collaborators to ensure CAPAs are appropriate and effective.
Manage and develop Quality Assurance personnel, including recruitment, performance management, hiring, training and development.
This may be for you if you:
* Want to be entrusted to support all IT compliance aspects of our science from conceptualization through manufacturing.
* Possess experiences to inspire others within your organization
* Have worked in a rapid response environment.
* Ability to think strategically and drive continuous improvement initiatives.
* Strong problem-solving skills ensuring sound decisions under pressure.
* Meticulous with a solid focus on quality and compliance.
To be considered for this role, you must have: Bachelor's degree in Information Technology, Computer Science, Life Sciences, or a related field along with 12+ years of experience in IT quality assurance and compliance within the biopharmaceutical industry. An advanced degree is preferred. Strong leadership and management skills, with experience in leading and developing high-performing teams. Strong communication and presentation skills.
Additional requirements:
* Extensive knowledge of GxP regulations, including GMP, GCP, and GLP
* Managing IT responsibilities for Health Authority and internal company audits. The ability to review, assess and defend critical audit observations where applicable.
* Ability to train staff in accordance with regulatory and company standards is critical.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$180,400.00 - $300,700.00
Oncology Regional Medical Scientific Director - Thoracic Malignancies - Southern CA (Remote)
Remote or Montgomery, AL Job
Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio.
The Oncology Regional Medical Scientific Director, RMSD, is a credentialed (i.e., MD, PhD, or PharmD) therapeutic and disease expert who engages in scientific exchange with leaders in the external medical and scientific community. Scientific exchange does not include promotional claims about any drug, vaccine or biologic product. RMSDs provide to Scientific Leaders (SLs) balanced, factual, scientific information about non-product areas of interest to the company. The RMSD provides research support to our Investigator-Sponsored and Company-Sponsored Trials to enhance the understanding of the scientific foundations and goals of the study, support patient enrollment and retention efforts for a given study or address Investigator questions. RMSDs also respond to scientific questions from SLs, including questions about company products. RMSDs have no sales objectives or accountability for prescribing or sales of any company product and are required to avoid any situations that could create the appearance that they have such responsibilities. An RMSD may not comment on or make suggestions with respect to the diagnosis, treatment, or circumstances of a specific patient.
**Location:**
+ This position covers the territory of southern CA, primarily Los Angeles, but will exclude San Diego. **Applicants must** **reside within the assigned territory.**
+ Up to 50% travel required with some overnight.
**Primary Responsibilities**
+ Develop professional relationships and communicate with national and regional scientific leaders to ensure access to medical and scientific information on areas of therapeutic interest and company products.
+ Conduct peer to peer scientific discussions and maintain a reliable presence with those scientific leaders to ensure they have a medical contact within the company.
+ Upon request from Global Clinical Trial Operations (GCTO), support Company-Sponsored Trials to enhance the understanding of scientific foundations and goals of the study, support patient enrollment and retention efforts or address investigator questions.
+ May initiate discussion with potential investigators to determine the level of interest and qualifications for a specific compound or trial.
+ Recommend potential study sites to Global Clinical Trial Operations (GCTO)/Clinical Research.
+ Address requests from investigators for information regarding participation in our Research and Development Division's studies.
+ Address scientific questions.
+ Studies to enhance the understanding of the scientific foundations and goals of the study, support patient enrollment and retention efforts or address investigator questions.
+ Investigator-Sponsored upon request from Global Center for Scientific Affairs (GCSA), support company
+ Share the company's " areas of interest' and discuss study concepts to assess scientific merit and alignment with the company's research strategies.
+ Respond to unsolicited requests for assistance from potential investigators in submitting research proposals by providing internal guidelines or technical and scientific advice.
+ Education and training to maintain current knowledge and understanding of dynamic scientific and clinical environment in the company's areas of interest.
+ Direct scientific leader inquiries on issues outside of RMSD scope of responsibilities (e.g., grants) to appropriate company resources consistent with applicable policies.
+ When requested by our Research and Development Division, serve as a resource for the identification of potential investigators for consideration for participating in phase II-IV clinical development programs
+ In response to unsolicited requests from scientific leaders, provide areas of interest and general high-level information regarding the company Investigator Study Program process.
+ Serve as a role model for other field medical team members, including on-boarding and/or therapeutic training partner.
+ Attend scientific and medical meetings.
**Education Minimum Requirement**
+ PhD, Pharm.D, MD, DNP
**Required Experience and Skills**
+ Clinical (patient care) or deep research experience in assigned therapeutic area(s) beyond that obtained in the terminal degree program.
+ A minimum of 3 years' experience and proven therapeutic competence in the oncology.
+ Capable of conducting doctoral level discussions with key external stakeholders
+ Strong focus on scientific education and dialogue
+ Business and market knowledge, including quality management.
+ Excellent interpersonal, communication, and networking skills
+ Must possess a thorough understanding of the United States Federal Drug Administration (FDA), Office of Inspector General (OIG), Health Insurance Portability and Accountability Act (HIPAA) and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry and its customers.
+ Must be able to organize, prioritize, and work effectively in a constantly changing environment.
+ Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Access).
**Preferred Experience and Skills**
+ Field-based medical experience
+ Clinical research experience
+ Demonstrated record of scientific/medical publication
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
Pay Transparency Nondiscrimination (***********************************************************************************************
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$206,200.00 - $324,600.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (********************************* .
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
50%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
02/11/2025
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R330273