Durham, England, United Kingdom · Hybrid
$139k–$231k/yr
Associate Director Regulatory Affairs, Oncology At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and deli…
Skills: Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance
Rockville, Maryland, United States · On-site
$19/hr–$24/hr
Shady Grove Medical Center If you are a current Adventist HealthCare employee, please click this link to apply through your Workday account. Shady Grove Medical Center seeks to hire a Certified Nursing Assistant for our …
Skills: Vital Signs Monitoring, Activities Of Daily Living, Patient Care, Basic Arithmetic, Computer Skills
Rockville, Maryland, United States · Hybrid
$70k–$105k/yr
Registered Nurse - Case Manager/Delegating Nurse - Montgomery County Community Nursing - Flexible Schedule - Partially Remote - No On-Call - Mileage Reimbursement - Benefits Package Competitive Pay Base Salary $70,000 - …
Skills: Case Management, Nursing Delegation, Clinical Assessment, Care Planning, Medication Administration
Rockville, Maryland, United States · Remote OK
$68k–$77k/yr
General Information Job Code: SHR-HC-02Location: Ripple Effect Headquarters – Rockville, MD Employee Type: Exempt, Full-Time RegularTelework: Fully RemoteSalary Range: $68,385.00 - $76,932.00 (how we pay and promote) Pos…
Skills: Social Media Management, Health Communications, Digital Engagement Strategy, Content Creation, Plain Language Writing
Rockville, Maryland, United States · On-site
$28/hr–$31/hr
About UNIPEC Universal Plastics & Engineering Company (UNIPEC), a UFP Technologies company, specializes in developing and manufacturing precision thermoformed and heat-sealed polymer components used primarily for shieldi…
Skills: Machining, Blueprint Reading, Precision Measuring, GD&T, Tooling Fabrication
Rockville, Maryland, United States · On-site
$100k–$180k/yr
It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. SummaryThere’s nothing more fulfilling than working with likeminded …
Skills: Pediatric Care, Acute Injury Treatment, Laceration Repair, Radiology Interpretation, Telemedicine
Rockville, Maryland, United States · On-site
$68k–$75k/yr
Position Summary The Medical Front Office Manager is responsible for overseeing the daily operations of the front office to ensure an exceptional patient experience while maintaining efficient, accurate, and compliant ad…
Skills: Team Leadership, Patient Experience Management, Healthcare Operations, Insurance Verification, HIPAA Compliance
Rockville, Maryland, United States · On-site
$100k–$180k/yr
It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. SummaryThere’s nothing more fulfilling than working with likeminded …
Skills: Pediatric Care, Acute Injury Treatment, Laceration Repair, Radiology Interpretation, Telemedicine
Rockville, Maryland, United States · On-site
$100k–$180k/yr
It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. SummaryThere’s nothing more fulfilling than working with likeminded …
Skills: Pediatric Care, Acute Injury Treatment, Laceration Repair, Radiology Interpretation, Telemedicine
Rockville, Maryland, United States · Hybrid
$113k–$188k/yr
Job Family: Strategy & Transformation Consulting Travel Required: None Clearance Required: Ability to Obtain Public Trust What You Will Do: You will support high-impact initiatives for the Food and Drug Administration, l…
Skills: Project Management, Executive Communication, Federal Consulting, Staffing Allocation, Risk Management
Rockville, Maryland, United States · On-site
$105k–$170k/yr
It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. SummaryThere’s nothing more fulfilling than working with likeminded …
Skills: Pediatric Care, Acute Injury Treatment, Laceration Repair, Radiology Interpretation, Telemedicine
Rockville, Maryland, United States · Remote OK
VetsEZ is currently looking for a Business Development & Capture Intern for a 100% remote position supporting our federal healthcare technology business. This internship is ideal for students currently pursuing an MBA, M…
Skills: Market Research, Competitive Intelligence, Capture Management, Proposal Development, Opportunity Qualification
Rockville, Maryland, United States · On-site
$26/hr–$28/hr
Overview Houry Pay: $26.45 to $28.85 depending on experience Location: 1445 Research Boulevard Suite 100, Rockville, Maryland 20850 Schedule: Monday to Friday, Alternating Shifts Three to Four Days Per Week: 8:30 AM to 4…
Skills: Case Management, Education Assessment, Crisis Intervention, Conflict Resolution, Care Coordination
Rockville, Maryland, United States · On-site
Shady Grove Medical Center If you are a current Adventist HealthCare employee, please click this link to apply through your Workday account. Shady Grove Medical Center seeks to hire an experienced Registered Nurse, for o…
Skills: Patient Assessment, Care Planning, Electronic Documentation, Clinical Intervention, Staff Mentoring
Rockville, Maryland, United States · On-site
$100k–$180k/yr
It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. SummaryThere’s nothing more fulfilling than working with likeminded …
Skills: Pediatric Care, Acute Injury Treatment, Laceration Repair, Radiology Interpretation, Telemedicine
Rockville, Maryland, United States · On-site
$85k–$100k/yr
About Us At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilities, equipment, and proc…
Skills: Project Management, DeltaV Automation, cGMP, FDA Regulations, Validation
Rockville, Maryland, United States · On-site
$100k–$180k/yr
It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. SummaryThere’s nothing more fulfilling than working with likeminded …
Skills: Pediatric Care, Acute Injury Treatment, Telemedicine, Laceration Repair, Abscess Drainage
Rockville, Maryland, United States · On-site
$20/hr–$30/hr
We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate…
Skills: Prescription Fulfillment, Patient Care, Inventory Management, Immunization Support, Customer Service
Rockville, Maryland, United States · On-site
$200k–$250k/yr
It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. SummaryThere’s nothing more fulfilling than working with likeminded …
Skills: Pediatric Care, Acute Injury Treatment, Telemedicine, Procedural Care, Radiology Interpretation
Rockville, Maryland, United States · On-site
$105k–$170k/yr
It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. SummaryThere’s nothing more fulfilling than working with likeminded …
Skills: Pediatric Care, Acute Injury Treatment, Laceration Repair, Radiograph Interpretation, Telemedicine
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Develop and execute global and regional regulatory strategies for oncology assets to ensure compliance and optimal labeling. Lead interactions with regulatory authorities and collaborate with cross-functional teams to meet medicine profiles.
Requires experience in all phases of drug development and leading regional submission and approval activities. A postgraduate degree and specific experience in Oncology regulatory affairs are preferred.
Associate Director Regulatory Affairs, Oncology
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.
Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionizing the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.
This role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Medicine Profile, commensurate with the available data.
Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile. Work closely with local / regional commercial team to secure best possible labeling commensurate with the available data. Lead interactions with local / regional regulatory authorities.
Key Responsibilities:
• Proactively develop regulatory strategy that will deliver the needs of the local region(s), taking into account the needs of other regions globally.
• Implement the regional strategy(s) in support of the project globally.
• Lead regulatory interactions and review processes in local region.
• Ensure appropriate interaction with global/regional counterparts and commercial teams in local region.
• Ensure compliance with global/ regional requirements at all stages of product life.
• Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset.
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
Experience of all phases of the drug development process in regulatory affairs preferred.
Experience leading regional development, submission and approval activities in local region(s).
Experience with clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.
Preferred Qualifications & Skills:
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
• Advanced Scientific Degree (PhD, MD, PharmD).
• Minimum of two years of experience in Oncology (Hematology or Solid Tumor) regulatory affairs.
• Strong matrix working skills, with the ability to facilitate dialogue and idea contribution among team members.
• Proactive problem-solving skills to identify and resolve project or team issues in advance.
• Creative regulatory problem-solving capabilities, balancing agency expectations and compliance.
• A focus on continuous improvement and excellence, with the ability to challenge current processes and recommend strategic changes.
• Ability to develop networks within GSK to secure support and achieve project outcomes.
#Li-GSK
• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $138,750 to $231,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [email protected]
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
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There are currently 474 open healthcare positions in Rockville, MD listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Adventist HealthCare, Samsung Biologics, PM Pediatric Care, JSSA, National Lutheran Communities & Services, among others. Browse the listings above to see every active employer.
Yes — 79 of the 474 open healthcare positions offer remote or hybrid work (37 remote, 42 hybrid).
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