Associate Director, Research Quality Assurance
for section headings (e.g. About the role, About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to decide which sections to include based on content.
We have:
- Intro: mission statement, location, flexible work. Could be "About the role" or maybe "About the company". Since they said "About the role" as example, we can use that for overview.
- Job Summary: description of role.
- Primary responsibilities: list.
- Essential Functions & Duties: broken into subcategories: Compliance Support, Create and Execute on Audit Plans, Management, Regulatory Agency Inspection Support. These are responsibilities/duties.
- Basic Qualifications: Bachelor's degree, 8+ years, GCP/GLP compliance and auditing experience.
- Preferred Qualifications: long list.
- Base Compensation: salary range, mention base pay depends, bonus, equity, benefits.
- Additional benefits: health care, vision, dental, retirement, PTO, etc.
- "Are you an Akebian?" description of culture.
- EEO statement (should be removed as boilerplate). Also "Visit our website" maybe not needed? It's not boilerplate but could be considered promotional; but we should preserve substantive information. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The EEO line is boilerplate, remove. The "Visit our website: www.akebia.com" maybe not boilerplate but could be considered promotional; but it's not required to remove. However it's not a substantive job detail; but it's okay to keep? Might be considered fluff. Safer to remove? The instruction only says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The website link is not those; we can keep.
We need to avoid repeating job title as heading. No job ID.
We need to use - for any list of duties/requirements/benefits, and
for prose.
We need to include sections only when posting has real specific content. So we can have sections: About the role (intro + job summary?), Responsibilities (primary responsibilities + essential functions), Qualifications (basic + preferred), Benefits (benefits + maybe PTO), Pay (salary range). Possibly Schedule? Not present. So we omit Schedule.
We need to preserve all substantive information; do not invent or summarize away detail. Must not omit details like flexible work, location, mission statement. Must include those in About the role section.
We need to format lists appropriately.
Let's extract content:
Intro paragraphs:
"Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees’ challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Please note that our offices recently relocated to Waltham, MA. We follow a flexible, “magnet not mandate” approach to in-office work, encouraging collaboration and onsite engagement while supporting hybrid flexibility based on role and business needs."
That's prose.
Job Summary:
"The Associate Director, Research and Development Quality Assurance provides technical leadership in programs managed by the Clinical Development, Global Medical Affairs organizations, and process managed by Drug Safety and Nonclinical Development. This position has the understanding of the regulatory requirements, experience, leadership, communication skills and business acumen to conduct responsibilities independently. Key areas of accountability for this role are to provide professional expertise and strong technical leadership in Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP) and applicable regulations and guidance and to proactively identify compliance issues/risks in assigned programs."
That's prose.
Primary responsibilities include but are not limited to: list:
- liaise with various internal R&D functions and external groups including contract auditors, clinical vendors and investigator sites in an effort to ensure a high level of quality and consistency across the studies;
- contribute to the audit strategy;
- assist project teams in identifying and implementing corrective and preventive actions;
- and enable teams to be inspection ready, in support of a culture of sustainable compliance.
That's a list.
Essential Functions & Duties: broken into categories with bullet-like sentences. We need to turn each bullet into
- . The content includes many sentences; we can treat each sentence as a list item. However we must preserve all substantive information; we can break them into items.
Let's list each bullet under each subheading.
Compliance Support:
- Serve in an advisory/consultative role in compliance related matters for clinical programs/projects and supports project team in identifying and implementing corrective and preventive actions
- Supports project team to be inspection ready with a culture of sustainable compliance
- Performs program specific investigations to identify root cause of compliance issues and provides the appropriate metrics for tracking, trending for the overall reporting requirements to functional and senior management
- Assists with continuous process improvement of the Clinical Quality system and RQA processes
- Support vendor qualification and internal audit program
- Escalate signals to RQA Management
- Provide consultation on, and interpretation of, regulations, guidance documents and industry standards.
- Provide support on Quality Issues to ensure appropriate investigation, root cause analysis and corrective and preventative actions.
- Create and Execute on Audit Plans (actually this is a separate heading; but we need to keep under Compliance Support? Actually the text shows "Create and Execute on Audit Plans" as a separate heading after Compliance Support. So we need to treat that as its own subsection.
Thus we need to structure: maybe we keep headings inside the Responsibilities section? But we only allowed
for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We cannot add custom headings like "Compliance Support". However we could still include those as ? Not allowed. The instruction says use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but likely they want only those standard headings. To be safe, we should not add extra headings beyond those. We can embed the subheadings as plain text within
or
- . But we need to preserve the structure; we could keep the subheading as plain text inside a
before the list.
Thus we can have a for Responsibilities with
Responsibilities
then a describing that responsibilities include... then a
with all duty items (including those from Primary responsibilities and Essential Functions). That would preserve all info.
Similarly for Qualifications: we can have Qualifications
then Basic Qualifications: ...
then for Preferred Qualifications items.
Benefits: we have "Additional benefits include health care, vision, dental, retirement, PTO, etc." plus mention of corporate bonus program, incentive compensation, equity. Also "Base pay is only one component of the company’s total rewards package". So we can have Benefits section with list.
Pay: we have salary range and statement about base pay depending on factors. So Pay section.
We should not include Schedule.
Now we need to ensure we don't include boilerplate like EEO line. Also remove duplicated lines. There's no duplication apparent.
Now craft HTML.
We'll start with About the role
then containing mission statement, location, flexible work, plus Job Summary? Actually Job Summary could be part of About the role or Responsibilities. Since About the role is for overview, we can include mission, location, flexible work, and Job Summary there. Then Responsibilities section for duties.
Let's compose About the role paragraph:
Combine:
"Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees’ challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Please note that our offices recently relocated to Waltham, MA. We follow a flexible, “magnet not mandate” approach to in-office work, encouraging collaboration and onsite engagement while supporting hybrid flexibility based on role and business needs.
The Associate Director, Research and Development Quality Assurance provides technical leadership in programs managed by the Clinical Development, Global Medical Affairs organizations, and process managed by Drug Safety and Nonclinical Development. This position has the understanding of the regulatory requirements, experience, leadership, communication skills and business acumen to conduct responsibilities independently. Key areas of accountability for this role are to provide professional expertise and strong technical leadership in Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP) and applicable regulations and guidance and to proactively identify compliance issues/risks in assigned programs."
That's a long paragraph; okay.
Now Responsibilities
Responsibilities
then a maybe short intro: "Primary responsibilities include but are not limited to:" then
with items.
We need to list all duties from Primary responsibilities and Essential Functions.
Let's compile list items:
From Primary responsibilities:
1. liaise with various internal R&D functions and external groups including contract auditors, clinical vendors and investigator sites in an effort to ensure a high level of quality and consistency across the studies
2. contribute to the audit strategy
3. assist project teams in identifying and implementing corrective and preventive actions
4. enable teams to be inspection ready, in support of a culture of sustainable compliance
From Essential Functions & Duties:
Compliance Support:
5. Serve in an advisory/consultative role in compliance related matters for clinical programs/projects and supports project team in identifying and implementing corrective and preventive actions
6. Supports project team to be inspection ready with a culture of sustainable compliance
7. Performs program specific investigations to identify root cause of compliance issues and provides the appropriate metrics for tracking, trending for the overall reporting requirements to functional and senior management
8. Assists with continuous process improvement of the Clinical Quality system and RQA processes
9. Support vendor qualification and internal audit program
10. Escalate signals to RQA Management
11. Provide consultation on, and interpretation of, regulations, guidance documents and industry standards.
12. Provide support on Quality Issues to ensure appropriate investigation, root cause analysis and corrective and preventative actions.
Create and Execute on Audit Plans:
13. Develop the audit strategy for clinical programs
14. Lead the execution of the audit activities associated with GCP, GPP, GLP and GVP to meet applicable regulatory requirements
15. Collaborate with key stakeholders from program teams, audit coordinators and/or other QA colleagues to ensure audit plan execution
16. Ensure the corrective and preventative actions are appropriate and completed in a timely manner
17. Oversee the timely development and distribution of audit reports and follow up actions
18. Assist in the review and identification of potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation
19. As appropriate, escalate issues of critical noncompliance and/or lack of urgency in remediation to senior
for prose. We need to include sections only when posting has real specific content. So we can have sections: About the role (intro + job summary?), Responsibilities (primary responsibilities + essential functions), Qualifications (basic + preferred), Benefits (benefits + maybe PTO), Pay (salary range). Possibly Schedule? Not present. So we omit Schedule. We need to preserve all substantive information; do not invent or summarize away detail. Must not omit details like flexible work, location, mission statement. Must include those in About the role section. We need to format lists appropriately. Let's extract content: Intro paragraphs: "Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees’ challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Please note that our offices recently relocated to Waltham, MA. We follow a flexible, “magnet not mandate” approach to in-office work, encouraging collaboration and onsite engagement while supporting hybrid flexibility based on role and business needs." That's prose. Job Summary: "The Associate Director, Research and Development Quality Assurance provides technical leadership in programs managed by the Clinical Development, Global Medical Affairs organizations, and process managed by Drug Safety and Nonclinical Development. This position has the understanding of the regulatory requirements, experience, leadership, communication skills and business acumen to conduct responsibilities independently. Key areas of accountability for this role are to provide professional expertise and strong technical leadership in Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP) and applicable regulations and guidance and to proactively identify compliance issues/risks in assigned programs." That's prose. Primary responsibilities include but are not limited to: list: - liaise with various internal R&D functions and external groups including contract auditors, clinical vendors and investigator sites in an effort to ensure a high level of quality and consistency across the studies; - contribute to the audit strategy; - assist project teams in identifying and implementing corrective and preventive actions; - and enable teams to be inspection ready, in support of a culture of sustainable compliance. That's a list. Essential Functions & Duties: broken into categories with bullet-like sentences. We need to turn each bullet into
for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We cannot add custom headings like "Compliance Support". However we could still include those as ? Not allowed. The instruction says use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but likely they want only those standard headings. To be safe, we should not add extra headings beyond those. We can embed the subheadings as plain text within
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but likely they want only those standard headings. To be safe, we should not add extra headings beyond those. We can embed the subheadings as plain text within
or
before the list. Thus we can have a for Responsibilities with
Responsibilities
then adescribing that responsibilities include... then a
- with all duty items (including those from Primary responsibilities and Essential Functions). That would preserve all info.
Similarly for Qualifications: we can have
Qualifications
thenBasic Qualifications: ...
then- for Preferred Qualifications items.
Benefits: we have "Additional benefits include health care, vision, dental, retirement, PTO, etc." plus mention of corporate bonus program, incentive compensation, equity. Also "Base pay is only one component of the company’s total rewards package". So we can have Benefits section with list.
Pay: we have salary range and statement about base pay depending on factors. So Pay section.
We should not include Schedule.
Now we need to ensure we don't include boilerplate like EEO line. Also remove duplicated lines. There's no duplication apparent.
Now craft HTML.
We'll start with
About the role
thencontaining mission statement, location, flexible work, plus Job Summary? Actually Job Summary could be part of About the role or Responsibilities. Since About the role is for overview, we can include mission, location, flexible work, and Job Summary there. Then Responsibilities section for duties. Let's compose About the role paragraph: Combine: "Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees’ challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Please note that our offices recently relocated to Waltham, MA. We follow a flexible, “magnet not mandate” approach to in-office work, encouraging collaboration and onsite engagement while supporting hybrid flexibility based on role and business needs. The Associate Director, Research and Development Quality Assurance provides technical leadership in programs managed by the Clinical Development, Global Medical Affairs organizations, and process managed by Drug Safety and Nonclinical Development. This position has the understanding of the regulatory requirements, experience, leadership, communication skills and business acumen to conduct responsibilities independently. Key areas of accountability for this role are to provide professional expertise and strong technical leadership in Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP) and applicable regulations and guidance and to proactively identify compliance issues/risks in assigned programs." That's a long paragraph; okay. Now Responsibilities
Responsibilities
then amaybe short intro: "Primary responsibilities include but are not limited to:" then
- with items.
We need to list all duties from Primary responsibilities and Essential Functions.
Let's compile list items:
From Primary responsibilities:
1. liaise with various internal R&D functions and external groups including contract auditors, clinical vendors and investigator sites in an effort to ensure a high level of quality and consistency across the studies
2. contribute to the audit strategy
3. assist project teams in identifying and implementing corrective and preventive actions
4. enable teams to be inspection ready, in support of a culture of sustainable compliance
From Essential Functions & Duties:
Compliance Support:
5. Serve in an advisory/consultative role in compliance related matters for clinical programs/projects and supports project team in identifying and implementing corrective and preventive actions
6. Supports project team to be inspection ready with a culture of sustainable compliance
7. Performs program specific investigations to identify root cause of compliance issues and provides the appropriate metrics for tracking, trending for the overall reporting requirements to functional and senior management
8. Assists with continuous process improvement of the Clinical Quality system and RQA processes
9. Support vendor qualification and internal audit program
10. Escalate signals to RQA Management
11. Provide consultation on, and interpretation of, regulations, guidance documents and industry standards.
12. Provide support on Quality Issues to ensure appropriate investigation, root cause analysis and corrective and preventative actions.
Create and Execute on Audit Plans:
13. Develop the audit strategy for clinical programs
14. Lead the execution of the audit activities associated with GCP, GPP, GLP and GVP to meet applicable regulatory requirements
15. Collaborate with key stakeholders from program teams, audit coordinators and/or other QA colleagues to ensure audit plan execution
16. Ensure the corrective and preventative actions are appropriate and completed in a timely manner
17. Oversee the timely development and distribution of audit reports and follow up actions
18. Assist in the review and identification of potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation
19. As appropriate, escalate issues of critical noncompliance and/or lack of urgency in remediation to senior