Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology - Hybrid
BioSpace · Irvine, CA · 4 wk ago
LegalFull-time
We need to output HTML fragment with sections: About the role? Actually the job description includes "Company Description", "Job Description", "Responsibilities, Qualifications, Additional Information (benefits). We must use for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We should only include sections that have real specific content. The posting includes:
- Company Description (maybe not needed as heading? Could be "About the role"? But they said do NOT repeat job title as heading; we can have "About the role" maybe summarizing description. However we need to preserve substantive info. The company description is about AbbVie mission etc. Could be placed under a heading like "About the role" or maybe "About AbbVie"? The instruction says use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can use those headings if content exists.
We have:
- Responsibilities: many bullet points.
- Qualifications: Minimum and Preferred.
- Benefits: mention of comprehensive package: paid time off, medical/dental/vision insurance, 401(k), long-term incentive programs.
- Pay: they mention compensation range but it's generic: "Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible basepay compensation...". However they didn't actually give numbers. So it's placeholder; we should NOT create Pay section unless posting actually states them. Since no numbers given, we should not include Pay.
- Schedule: they mention hybrid work schedule (3 days in office & 2 days remotely) from locations. That's schedule info. So we can include Schedule section.
- Skills: maybe not explicitly listed; but we have negotiation skills, communication skills, etc. Could be under Skills. However we might combine into Qualifications. The instruction: prefer a few substantive sections over many thin ones. We could have Responsibilities, Qualifications, Benefits, Schedule. Possibly also About the role (company description). But we could incorporate company description into About the role.
We must not repeat job title as heading. So we can have
for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We should only include sections that have real specific content. The posting includes:
- Company Description (maybe not needed as heading? Could be "About the role"? But they said do NOT repeat job title as heading; we can have "About the role" maybe summarizing description. However we need to preserve substantive info. The company description is about AbbVie mission etc. Could be placed under a heading like "About the role" or maybe "About AbbVie"? The instruction says use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can use those headings if content exists.
We have:
- Responsibilities: many bullet points.
- Qualifications: Minimum and Preferred.
- Benefits: mention of comprehensive package: paid time off, medical/dental/vision insurance, 401(k), long-term incentive programs.
- Pay: they mention compensation range but it's generic: "Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible basepay compensation...". However they didn't actually give numbers. So it's placeholder; we should NOT create Pay section unless posting actually states them. Since no numbers given, we should not include Pay.
- Schedule: they mention hybrid work schedule (3 days in office & 2 days remotely) from locations. That's schedule info. So we can include Schedule section.
- Skills: maybe not explicitly listed; but we have negotiation skills, communication skills, etc. Could be under Skills. However we might combine into Qualifications. The instruction: prefer a few substantive sections over many thin ones. We could have Responsibilities, Qualifications, Benefits, Schedule. Possibly also About the role (company description). But we could incorporate company description into About the role.
We must not repeat job title as heading. So we can have About the role
with paragraph summarizing company description and job description overview.
We must use - for any list of duties/requirements/benefits. So responsibilities list as ul. Qualifications maybe as ul (minimum and preferred). Benefits as ul.
We need to preserve ALL substantive information; do not invent or summarize away detail. So we need to keep all bullet points exactly as given (or close). Must not omit any.
Let's extract responsibilities bullet points:
From text:
"Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVies interests.
Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations.
Drafts and finalizes comments in a timely manner, to regulators and trade associations.
Distributes proposed policies to SMEs.
Highlights key points in a clear and concise manner.
Represents department and participates in trade associations as needed.
Develops good working relationships with trade association managers.
Summarizes findings, under supervision, in concise reports for distribution within AbbVie
Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies.
Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
Development and guides implementation strategies for promotional activities
Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports.
Manages direct reports and assists in the development, training and mentoring of staff members
Effectively presents pertinent information to appropriate cross-functional groups.
Effectively delivers difficult messages to commercial organizations without damage to relationships
Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange."
Some lines seem fragmented; we need to keep them as is. Might need to split into separate li items where appropriate. The text includes some sentences that are not clearly separated by periods. We'll treat each sentence as a bullet.
Let's list them:
1. Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVies interests.
2. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations.
3. Drafts and finalizes comments in a timely manner, to regulators and trade associations.
4. Distributes proposed policies to SMEs.
5. Highlights key points in a clear and concise manner.
6. Represents department and participates in trade associations as needed.
7. Develops good working relationships with trade association managers.
8. Summarizes findings, under supervision, in concise reports for distribution within AbbVie
9. Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies.
10. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
11. Development and guides implementation strategies for promotional activities
12. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
13. Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports.
14. Manages direct reports and assists in the development, training and mentoring of staff members
15. Effectively presents pertinent information to appropriate cross-functional groups.
16. Effectively delivers difficult messages to commercial organizations without damage to relationships
17. Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.
Note: Some lines missing period; we keep as is.
Qualifications:
Minimum: Bachelors degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
PreferredPharmD degree plus 5years ofrelevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
Experience working in a complex and matrix environment and exhibits strong negotiation skills
Strong communication skills, both oral and written
Experience In Management Capacity Preferred
Experience in US Regulatory Affairs Advertising and Promotion
We need to keep as list items.
Benefits:
"We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible toparticipatein our long-term incentiveprograms."
Also maybe mention other benefits? That's it.
Schedule:
"This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA."
Also mention "Significant Work Activities:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required". That's also schedule/work activity; could be included under Schedule or maybe a separate section? But we only have headings list; we could include under Schedule as part of schedule description. Or we could add a separate "Work Activities" but not in allowed headings. Better to incorporate into Schedule section.
Thus Schedule section will include hybrid schedule and significant work activity.
Now About the role: we can combine company description and job description overview.
Company Description: "AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube."
Job Description overview: The first paragraph: "TheSenior Manager Regulatory Affairs US Advertising and Promotion-Immunologycombines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies."
We need to preserve that text. We'll put into a paragraph.
Now we must not include boilerplate like EEO, equal opportunity, etc. Remove those lines at end.
Now produce HTML fragment:
About the role
...
Responsibilities
- ...
...
Qualifications
- ...
...
Benefits
- ...
...
Schedule
... hybrid schedule ...
... Significant Work Activities: ...
We need to ensure we don't include empty sections.
Now let's craft the text precisely.
About the role paragraph: combine both paragraphs.
Let's copy exactly:
"AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.
The Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies."
Note: original had "TheSenior Manager" no space; we need to add space for readability but must preserve info; adding a space is not changing substantive info? It's formatting; likely okay. We'll keep as is but maybe keep original spacing? The original had no space after "The". But we can add a space; it's not altering meaning. Safer to keep exactly as original? The instruction: preserve ALL substantive information; adding a space is not substantive. I'll keep original but add a space after "The" for readability? Might be considered altering. I'll keep original exactly: "TheSenior Manager Regulatory Affairs US Advertising and Promotion-Immunologycombines knowledge..." That's awkward but okay.
I'll keep original string.
Now responsibilities list: need to ensure each bullet ends with proper punctuation as in original.
Let's copy each bullet exactly as in text, preserving line breaks.
Original responsibilities block:
"Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVies interests.
Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations.
Drafts and finalizes comments in a timely manner, to regulators and trade associations.
Distributes proposed policies to SMEs.
Highlights key
About the role
...
Responsibilities
- ... ...
Qualifications
- ... ...
Benefits
- ... ...
Schedule
... hybrid schedule ...
... Significant Work Activities: ...
We need to ensure we don't include empty sections. Now let's craft the text precisely. About the role paragraph: combine both paragraphs. Let's copy exactly: "AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube. The Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies." Note: original had "TheSenior Manager" no space; we need to add space for readability but must preserve info; adding a space is not changing substantive info? It's formatting; likely okay. We'll keep as is but maybe keep original spacing? The original had no space after "The". But we can add a space; it's not altering meaning. Safer to keep exactly as original? The instruction: preserve ALL substantive information; adding a space is not substantive. I'll keep original but add a space after "The" for readability? Might be considered altering. I'll keep original exactly: "TheSenior Manager Regulatory Affairs US Advertising and Promotion-Immunologycombines knowledge..." That's awkward but okay. I'll keep original string. Now responsibilities list: need to ensure each bullet ends with proper punctuation as in original. Let's copy each bullet exactly as in text, preserving line breaks. Original responsibilities block: "Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVies interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key