Associate Director, Regulatory Affairs Advertising - Boston, United States - argenx SE

argenx SE Boston, United States

1 week ago

Description

Associate Director, Regulatory Affairs Advertising & Promotion page is loaded

Associate Director, Regulatory Affairs Advertising & Promotion

Apply

locations

Boston

time type

Full time

posted on

Posted 4 Days Ago

job requisition id

REQ-2604

The Associate Director, Regulatory Affairs Advertising & Promotion will be responsible for providing strategic, operational and tactical regulatory advice to internal stakeholders regarding communications about investigational product pipeline assets and approved prescription products ensuring they comply with US laws and regulations and company policies, while supporting achievement of business objectives.

Provides regulatory review of advertising and promotional labeling, disease awareness and training materials, new campaigns, and product launch strategies.

Roles and Responsibilities:

Serves as subject matter expert on FDA regulations and OPDP guidance governing promotion and prescription drug/ biologic products and disease awareness activities.

Participates on multidisciplinary medical, legal and regulatory review team with individual responsibility for the review, risk assessment, and Regulatory decisions regarding product communications.

Provides regulatory strategic oversight for at least one (1) complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional and non-promotional materials assigned, including management of Form 2253 submissions.

Ensures that US Prescribing Information (USPI) is accurately and contextually applied to relevant external communications and changes to USPI are incorporated within a timely manner.

Monitors and keeps organization abreast on US regulatory promotional environment (e.g., the issuance of new FDA regulations/guidance documents, relevant FDA enforcement action and general awareness of industry practices, including those of competitors).

Contributes to culture of compliance at argenx by participating as needed in training argenx personnel on promotional, marketing, labeling and advertising regulations and updates.

Skills and Competencies:
Ability to maintain collaborative, efficient, and effective working relations with cross-functional argenx teams (commercial, medical, legal and regulatory).
Strong interpersonal, oral and written communication skills
Understands business goals and common marketing concepts/tools
High degree of professional ethics, integrity and responsibility
Shows flexibility and is open to change in a growing, multi-cultural environment
Capable of strategic thinking and proposing innovative solutions involving regulatory issues, while being a team player who invites response and discussion
Comfortable in a fast-paced, results-driven, and highly accountable work environment
Analytical and Problem-Solving Skills - ability to understand complex issues and propose achievable solutions
Working knowledge of Veeva PromoMats
T his position is a hybrid role located in Boston, MA.
#

LI-Hybrid
At argenx we strive to create a welcoming and inclusive environment.

Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.

argenx is proud to be an equal opportunity employer.

If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us .

Only inquiries related to an accommodation request will receive a response.

About Us

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer.

Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines.

argenx is evaluating efgartigimod in multiple serious autoimmune diseases. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan, and Switzerland.

#J-18808-Ljbffr

Faculty/Academic Affairs Coordinator

6 days ago

Integrated Resources Boston, United States

Faculty/Academic Affairs Coordinator · This position will provide support to the Faculty /Academic Affairs Office at the Pardee School of Global Studies. Specifically, the position will play a crucial role in the recruiting and hiring of new faculty as well as in the process of ...
PROJECT FINANCIAL ANALYST, Business Affairs

1 week ago

Merchant Flow Financial Boston, United States

PROJECT FINANCIAL ANALYST, Business Affairs · Tracking Code: · Job Description · Reporting to the Assistant Director of Capital Planning, the Project Financial Analyst performs a variety of tasks related to the management budget and fiscal affairs for University space planning, ...
Regulatory Affairs Strategy Director or Associate Director

2 weeks ago

Dennis Partners Boston, United States

Our client is developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders. They are seeking a Regulatory Affairs Strategy Director or Associate Director who can develop and execute global regulatory strategy plans for their clinical-st ...
STAFF ACCOUNTANT, GIFTS

1 week ago

MassCPAs Boston, United States

STAFF ACCOUNTANT, GIFTS & ENDOWMENT, Financial Affairs, Comptroller's Office, General Accounting · Tracking Code: · Job Description · The Staff Accountant is a key member of General Accounting and Financial Reporting team here at Boston University. This position has the potenti ...
Faculty Affairs Coordinator

6 days ago

Brigham & Women's Hospital(BWH) Boston, United States

GENERAL SUMMARY/ OVERVIEW STATEMENT: Summarize the nature and level of work performed. · The Faculty Affairs Coordinator is an integral part of Department Administration requiring a high degree of independence to oversee and execute Department Administration.This position is res ...
Regulatory Affairs Associate

1 week ago

INTELLECTT INC Boston, United States

Role: Regulatory Affairs Associate · Location: Remote · Duration: 7 Months · Main Responsibilities · Provide regulatory input to product lifecycle planning. Assist in SOP development and review. · Assist in the development of regional regulatory strategy and update strategy ...
Director, Regulatory Affairs Operations

4 days ago

Olema Oncology Boston, United States

Who We Are >>> Why You Should Work With Us · Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women's cancers. Olema's lead product candidate, palazestrant (OP-1250), is a proprieta ...
Vice President Marketing

1 week ago

CareQuest Institute for Oral Health Boston, United States

The Vice President, Marketing will support the mission of the Enterprise (CareQuest Institute and CareQuest Innovation Partners) and be responsible for advancing and managing the organization's external image, outreach, and engagement through the areas of Brand Marketing, Content ...
TAX ANALYST, Financial Affairs, Comptroller's Office, General Accounting

1 week ago

Acord (association For Cooperative Operations Research And Development) Boston, United States

TAX ANALYST, Financial Affairs, Comptroller's Office, General Accounting · Tracking Code: · Job Description · The Tax Analyst is a key member of General Accounting and Financial Reporting team here at Boston University. This position has the potential to work a hybrid schedule ...
Director of Retail

4 days ago

Jushi Holdings Inc. Boston, United States

**Jushi** · **Director of Retail** · **Retail - Boston, MA - Full Time** · **THE OPPORTUNITY** · The Director of Retail will be responsible for the in-store customer experience to ensure that every location consistently reflects the companys brand image. The Director of Retai ...
Sr. Administrative Associate

1 week ago

Children's Hospital Boston Boston, United States

74651BRJob Posting Title:Sr. Administrative Associate - International Health Affairs (onsite)Department:International AffairsAutoReqId:74651BRStatus:Full-TimeStandard Hours per Week:40 Job Posting Category:AdministrationJob Posting Description:This position is a front-desk recept ...
Vice President of Marketing and Communications

1 week ago

Massachusetts Clean Energy Center Boston, MA, US, United States

Job Type: Full-time · Pay: $125,000 - $135,000 per year, dependent on experience and education · Benefits: 457b plan and matching; Medical coverage and 100% deductible coverage through HRA; Dental coverage; Vision coverage; Life insurance; Paid time off; Parental leave; Tuition R ...
Vice President of Marketing and Communications

55 minutes ago

Massachusetts Clean Energy Center Boston, United States

Job Type: · Full-time · Pay: · $125,000 - $135,000 per year, dependent on experience and education · Benefits: · 457b plan and matching; Medical coverage and 100% deductible coverage through HRA; Dental coverage; Vision coverage; Life insurance; Paid time off; Parental leave; ...
Senior Product Manager, Lung

4 days ago

Takeda Oncology Boston, United States

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...
Senior Product Manager, Lung

2 weeks ago

Takeda Boston, United States

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
Senior Product Manager, Lung

2 weeks ago

Takeda Pharmaceuticals Boston, United States

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...
Senior Product Manager, Lung

1 week ago

Workday Boston, United States

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that · the information I provide in my application will be processed in line with · Takeda's · Privacy Notice · and · Terms of Use . · I further attest that all ...
Professor and Associate Dean of Nursing

1 week ago

University of Massachusetts Boston, United States

Professor and Associate Dean of Nursing · Job no: · 519880 · Work type: · Faculty Full Time · Campus: · UMass Boston · Department: · Nursing · Pay Grade: · No Pay Grade · Categories: · Faculty, College of Nursing · The University of Massachusetts Boston (UMass Boston) inv ...