Associate Director/Associate Principal Scientist, GRACS Regulatory Digital Health (Hybrid)
Job DescriptionTeam Overview:
The GRACS Regulatory Digital Health team assists in bringing new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies.
We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world through a highly regulated industry.
Position Overview:
Under the direction and guidance of the Regulatory Digital Health (RDH) leadership and their manager, the incumbent will assist in driving the overarching strategy for all Medical Device Modalities including, but not limited to:
Complex Combination Products, diagnostics, and digital health in partnership with the Global Regulatory Leads (GRLs), Chemistry, Manufacturing and Control (CMC) scientists, Pharmacovigilance (PV), Global Labeling (GL), and various other functions.
The incumbent will help drive the development of new processes and establishment of internal guidance/policy that enables timely and accurate advice to Global Regulatory Teams and Product Development Teams to ensure adherence to evolving global regulations.
The incumbent will partner with internal organizations to ensure the development and clinical aspects needed to support, plan, and/or execute regulatory filings.
Primary duties/assignments:
Communication and assessment of the emerging regulatory landscape and drive cross functional implementation of existing and new requirements across the affected functional areas for digital health solutions.
Development of best practice guidance for regulatory deliverables for digital health, diagnostics, and complex combination products to support the therapeutically aligned development teams.
Schedule as needed and actively facilitate discussions and interactions with cross functional and cross divisional teams and/or external partners.
Provide support to assigned Global Regulatory Teams (GRTs) to bring broad-based perspective on digital health aspects impacting product development and share leading practices for teams to incorporate into their regulatory strategies.
Collaborate with the Policy Execution Team for the assessment, implementation, and tracking of new and updated global regulatory policies for IQSE (Innovation, Quality, and Strategic Execution).
Contribute to the strategic vision and planning of new digital health initiatives that establish operational processes and systems to fully incorporate device and digital health into our company's way of working across the broad product portfolio.
Ensure close collaboration with cross functional and cross divisional teams (Research, Manufacturing, Commercial, IT) to align on and incorporate regulatory requirements into strategies for digital health solutions and complex combination products (with connectivity) to ensure successful product registrations.
Provide technical expertise in support of organizational risk management initiatives, including providing audit/assessment support.
Education:
Minimum:
Bachelor's Degree in Regulatory Affairs, Quality Assurance, Clinical Affairs, Pharmacovigilance, Biology, Engineering, Chemistry, or related science field.
Preferred:
Advanced degree and/or RAPS RAC, ASQ Quality, PMP, or Scrum certifications.
Required Experience and Skills:
At least five (5) years of relevant experience, including medical device/biological/ pharmaceutical research; compliance, manufacturing, testing, quality, regulatory affairs, or related fields.
Knowledgeable in the global regulatory requirements and emerging landscape for Drugs, Digital Health Technologies, and/or Combination products for both new product development for initial registration and maintenance of registrations.
Excellent business acumen, stakeholder management, communication, and influencing skills and ability to manage conflict.
The ability to lead global teams in the assessment, implementation, and tracking of new and updated Global Regulatory Policies.
Excellent time-management, problem-solving, and organizational skills in a constantly changing, ambiguous environment.
Broad awareness of the strategy for digital health technologies and their application to drug development and marketed biopharmaceutical products.
NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
GRACSJOBS#EBRGEmployees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERECurrent Contingent Workers apply HEREUS 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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe 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.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work ModelEffective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job.
Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$118,640.
00 - $186,800.
00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
For Washington State Jobs, a summary of benefits is listed here.
Learn more about your rights, including under California, Colorado and other US State ActsSearch Firm Representatives Please Read Carefully Merck & Co.
, Inc.
, Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Where agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Flex Time, HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
na Recommended Skills Auditing Biology Certified Project Management Professional Clinical Works Commercial Awareness Coordinating Estimated Salary: $20 to $28 per hour based on qualifications.
The GRACS Regulatory Digital Health team assists in bringing new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies.
We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world through a highly regulated industry.
Position Overview:
Under the direction and guidance of the Regulatory Digital Health (RDH) leadership and their manager, the incumbent will assist in driving the overarching strategy for all Medical Device Modalities including, but not limited to:
Complex Combination Products, diagnostics, and digital health in partnership with the Global Regulatory Leads (GRLs), Chemistry, Manufacturing and Control (CMC) scientists, Pharmacovigilance (PV), Global Labeling (GL), and various other functions.
The incumbent will help drive the development of new processes and establishment of internal guidance/policy that enables timely and accurate advice to Global Regulatory Teams and Product Development Teams to ensure adherence to evolving global regulations.
The incumbent will partner with internal organizations to ensure the development and clinical aspects needed to support, plan, and/or execute regulatory filings.
Primary duties/assignments:
Communication and assessment of the emerging regulatory landscape and drive cross functional implementation of existing and new requirements across the affected functional areas for digital health solutions.
Development of best practice guidance for regulatory deliverables for digital health, diagnostics, and complex combination products to support the therapeutically aligned development teams.
Schedule as needed and actively facilitate discussions and interactions with cross functional and cross divisional teams and/or external partners.
Provide support to assigned Global Regulatory Teams (GRTs) to bring broad-based perspective on digital health aspects impacting product development and share leading practices for teams to incorporate into their regulatory strategies.
Collaborate with the Policy Execution Team for the assessment, implementation, and tracking of new and updated global regulatory policies for IQSE (Innovation, Quality, and Strategic Execution).
Contribute to the strategic vision and planning of new digital health initiatives that establish operational processes and systems to fully incorporate device and digital health into our company's way of working across the broad product portfolio.
Ensure close collaboration with cross functional and cross divisional teams (Research, Manufacturing, Commercial, IT) to align on and incorporate regulatory requirements into strategies for digital health solutions and complex combination products (with connectivity) to ensure successful product registrations.
Provide technical expertise in support of organizational risk management initiatives, including providing audit/assessment support.
Education:
Minimum:
Bachelor's Degree in Regulatory Affairs, Quality Assurance, Clinical Affairs, Pharmacovigilance, Biology, Engineering, Chemistry, or related science field.
Preferred:
Advanced degree and/or RAPS RAC, ASQ Quality, PMP, or Scrum certifications.
Required Experience and Skills:
At least five (5) years of relevant experience, including medical device/biological/ pharmaceutical research; compliance, manufacturing, testing, quality, regulatory affairs, or related fields.
Knowledgeable in the global regulatory requirements and emerging landscape for Drugs, Digital Health Technologies, and/or Combination products for both new product development for initial registration and maintenance of registrations.
Excellent business acumen, stakeholder management, communication, and influencing skills and ability to manage conflict.
The ability to lead global teams in the assessment, implementation, and tracking of new and updated Global Regulatory Policies.
Excellent time-management, problem-solving, and organizational skills in a constantly changing, ambiguous environment.
Broad awareness of the strategy for digital health technologies and their application to drug development and marketed biopharmaceutical products.
NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
GRACSJOBS#EBRGEmployees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERECurrent Contingent Workers apply HEREUS 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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe 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.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work ModelEffective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job.
Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$118,640.
00 - $186,800.
00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
For Washington State Jobs, a summary of benefits is listed here.
Learn more about your rights, including under California, Colorado and other US State ActsSearch Firm Representatives Please Read Carefully Merck & Co.
, Inc.
, Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Where agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Flex Time, HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
na Recommended Skills Auditing Biology Certified Project Management Professional Clinical Works Commercial Awareness Coordinating Estimated Salary: $20 to $28 per hour based on qualifications.
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