Sr. Manager, Regulatory Affairs Advertising & Promotion - Remote, Emergent BioSolutions, Gaithersburg, MD
Emergent BioSolutions -
Gaithersburg, MD,
US
Sr. Manager, Regulatory Affairs Advertising & Promotion - Remote
Date Posted: 2024-06-14
Job description
We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
JOB SUMMARY
The Senior Manager RA Advertising and Promotion will help support advertising and promotion efforts across the enterprise at Emergent. The position will lead in developing and communicating RA Advertising and Promotion strategy to internal stakeholders, providing regulatory strategy, direction, support, and advice to the commercial teams. The position will interact closely with team members from Commercial, Medical Affairs, Marketing, Legal, and Compliance, and will represent RA on the various internal Promotional Review Committees.
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Leading voice for regulatory activities pertaining to the development of promotional and non-promotional material for external use.
Review internal communications intended for training, learning and development, and education.
Establish and collaborate on development of internal processes, standards and best practices to ensure promotional compliance and quality.
Provide training to other functions on Health Authority requirements.
Monitor corporate activities for regulatory compliance.
Provide critical regulatory review of promotional and non-promotional external communications.
Preparation of Promotional Labeling and Advertising submissions to OPDP/APLB.
Work closely with Regulatory Operations to ensure on-time submission of required documents.
Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed.
Present to Sr Management and drive decisions on complex material.
Interact with company partners and consultants for various regulatory matters as needed.
Interact with business unit teams, other functional managers, and internal/external customers.
Participate in Regulatory Department initiatives, such as process improvement projects.
Other duties as assigned.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
Bachelor's degree in life science field or healthcare-related field is required
Advanced degree in pharmacy, regulatory affairs, nursing or other life science is preferred
5-7 years of experience in Regulatory Affairs, Advertising and Promotion required; manager experience preferred
8-10 years of experience in US/global pharmaceutical industry required
Experience in global regulatory affairs (EU, Canada) preferred
Experience in regulatory submissions required
Biological and vaccine product experience preferred
Strong written and verbal communication skills.
Experience with Veeva suite products preferred
Strong interpersonal skills
Is able to direct work as required and manage complexity
Able to anticipate and prevent potential issues
Careful attention to detail and accuracy required
Extensive knowledge of MS Word, Project, PowerPoint, Excel, and other MS Office applications and Adobe Acrobat
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
ABOUT EMERGENT
Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.
Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal.
WE BELIEVE IN OUR VALUES
JOB SUMMARY
The Senior Manager RA Advertising and Promotion will help support advertising and promotion efforts across the enterprise at Emergent. The position will lead in developing and communicating RA Advertising and Promotion strategy to internal stakeholders, providing regulatory strategy, direction, support, and advice to the commercial teams. The position will interact closely with team members from Commercial, Medical Affairs, Marketing, Legal, and Compliance, and will represent RA on the various internal Promotional Review Committees.
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Leading voice for regulatory activities pertaining to the development of promotional and non-promotional material for external use.
Review internal communications intended for training, learning and development, and education.
Establish and collaborate on development of internal processes, standards and best practices to ensure promotional compliance and quality.
Provide training to other functions on Health Authority requirements.
Monitor corporate activities for regulatory compliance.
Provide critical regulatory review of promotional and non-promotional external communications.
Preparation of Promotional Labeling and Advertising submissions to OPDP/APLB.
Work closely with Regulatory Operations to ensure on-time submission of required documents.
Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed.
Present to Sr Management and drive decisions on complex material.
Interact with company partners and consultants for various regulatory matters as needed.
Interact with business unit teams, other functional managers, and internal/external customers.
Participate in Regulatory Department initiatives, such as process improvement projects.
Other duties as assigned.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
Bachelor's degree in life science field or healthcare-related field is required
Advanced degree in pharmacy, regulatory affairs, nursing or other life science is preferred
5-7 years of experience in Regulatory Affairs, Advertising and Promotion required; manager experience preferred
8-10 years of experience in US/global pharmaceutical industry required
Experience in global regulatory affairs (EU, Canada) preferred
Experience in regulatory submissions required
Biological and vaccine product experience preferred
Strong written and verbal communication skills.
Experience with Veeva suite products preferred
Strong interpersonal skills
Is able to direct work as required and manage complexity
Able to anticipate and prevent potential issues
Careful attention to detail and accuracy required
Extensive knowledge of MS Word, Project, PowerPoint, Excel, and other MS Office applications and Adobe Acrobat
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
ABOUT EMERGENT
Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.
Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal.
WE BELIEVE IN OUR VALUES
- Lead with Integrity
- We gain trust and confidence through ethics, quality, and compliance excellence
- Stand shoulder to shoulder no matter what
- We combine our best thinking and communicate openly to support each other.
- Own it always
- Every person at Emergent is engaged and accountable for delivering on our commitments.
- Break through thinking
- We take smart risks, pursue innovation and challenge ourselves to constantly improve.
- Compete where it counts
- We set the right goals and respect each other as we conquer them together.