Regulatory Affairs Associate - Advertising & Promotional Labeling Job at Parexel (Remote)

Director, Regulatory Labeling

Beam is seeking a Director of Regulatory Affairs – Advertising, Labeling, and Pr...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS required
an advanced degree (i.e. MS, PharmD, PhD, MD) is a plus
A minimum of 6 years of experience working in Regulatory Affairs Advertising, Labeling, and Promotion
ideally 15 plus years in the biotech industry with at least 8 years in regulatory affairs
Record of success with interactions with Regulatory Agencies and Health Authorities as part of label negotiations and label updates
Comprehensive knowledge of US and global regulatory procedures and practices
Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP)
Strong strategic thinking and problem-solving skills
Experience in representing programs to internal and external stakeholders
Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendors

Job Responsibility

Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profiles
Lead labeling negotiations between Beam and health authorities as part of marketing authorization applications
Create regulatory labeling processes and associated SOPs, Work Instructions, and any other required documentation
Represent Regulatory Affairs as part of the Promotional Review Process
Incorporate the evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, and prescription drug labeling
Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risks
Guide and assist on the planning, preparation, writing and submission of regulatory documentation
Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time
Provide regulatory due diligence as required
Supervise and mentor direct reports

Fulltime

Regulatory Affairs Specialist

This position will be working in the BD Interventional Surgery Business Unit on ...

Location

United States , Warwick

Salary:

Not provided

BD

Expiration Date

Until further notice

Requirements

B.A. or B.S. degree in a technical field preferred (e.g., engineering, biology, chemistry, health science). B.A. or B.S. in other field acceptable with appropriate level of experience
Minimum 1-2 years Regulatory Affairs experience in medical device or in vitro diagnostic device companies
Proven ability to resolve problems and to make appropriate regulatory decisions
Good oral and written communications skills - analytical thinking and technical writing
ability to work on cross-functional teams
ability to manage several parallel deliverables
Proficient in using Microsoft Word, Excel, PowerPoint, and Project
Strong communication and project management skills
Must be able to handle multiple tasks with attention to detail with limited supervision
Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills

Job Responsibility

Assess necessity for reporting changes to FDA/Notified Body for proposed device modifications. Prepare robust reporting justifications for changes that do not require supplements or notices. Sends out notifications of change to Notified Body as required
Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to stakeholders
Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards
Maintains regulatory databases/systems for key regulatory data
Remains current on regulations affecting BD products and keep the relevant team and supervisors informed about potential product or process impacts
Provides regulatory support during internal/external audits and inspections
Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register devices worldwide
Review and approve product labeling, promotional, and advertising materials to ensure regulatory compliance
Carry out the above tasks with minimal supervision

Fulltime

Associate Manager of Marketing - Elastomeric Infusion

This is where creativity meets strategy. As a member of the Baxter Marketing tea...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Compelling & Concise Communication
Creative & Innovative Thinking
Strategic Planning
Competitive Intelligence
Collaborative
Digitally Savvy

Job Responsibility

Owns and execute global marketing strategy for the elastomeric portfolio across the full product lifecycle, including NPD, sustaining initiatives, regulatory transitions, cost reduction, and product phase-out
Develop and maintain portfolio roadmaps, prioritization recommendations, and resource needs in alignment with business objectives
Identify unmet customer needs and growth opportunities through market analysis, competitive benchmarking, and customer engagement
Serve as the global marketing member on project core teams for NPD and SPO initiatives, representing the voice of the customer throughout the development process
Define and communicate market and customer requirements, including intended use, value propositions, and usability insights, in partnership with R&D and Marketing Communications
Lead or support market research activities such as customer usability studies, willingness‑to‑pay assessments, qualitative interviews, and quantitative research
Conduct market impact assessments for product changes (i.e., change control) and own assigned marketing deliverables
Develop commercial business cases, in partnership with Finance, to support new product and portfolio initiatives
Support development of global value propositions and pricing strategies informed by customer needs and competitive dynamics
Monitor and benchmark competitive offerings, identifying implications for portfolio strategy and positioning

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

New

Digital Communications System Technician

The Digital Communications Systems Technician (DCS Tech) works under the directi...

Location

United States , Los Angeles

Salary:

Not provided

Dash Technologies

Expiration Date

Until further notice

Requirements

At least three (3) years of experience in the installation, configuration, testing, maintenance, and repair of digital telephone private branch exchange (PBX) and key switching systems. One (1) year must have been at the journey-level
Five or more years of experience with NEC PBX systems, Nortel Norstar Key phone system (MICS, Call-pilot, Trunk/station modules, RAD) and VOIP products (Cisco, Microsoft Teams Voice)
High school diploma or GED certificate
Valid class C driver's license with no restrictions
Physical dexterity, color perception, and visual acuity

Job Responsibility

Install, configure, test, maintain, and repair analog, digital telephone or data communications systems and equipment
Install, configure, test, maintain, and repair analog, digital and Internet based communications systems, infrastructure, and equipment, including servers supporting applications such as voicemail, call recording, automated telephone attendants, interactive voice response, digital network telecommunications circuits, and digital communications equipment such as modems, channel banks, multiplexers, and repeaters
Install, program, test, maintain, and repair private branch exchange (PBX) and key telephone switching systems, Cloud Services (MS TEAMS, Web-EX, Zoom) and related equipment
Install, rehabilitate, and remove cabling infrastructure such as copper and fiber-optic cables, wire management systems, patch panels and jacks according to industry standards
Test, troubleshoot, and repair telephone and network cabling
Provide technical support for telephone equipment moves, equipment added, or equipment changes
Confer and consult with vendors and other County department representatives regarding operational problems, repair, maintenance, and installation of digital communications systems and equipment
Work closely with vendors regarding operational problems, repair, modification, and installation of software, hardware, and circuits
Configure, add, move, change, and troubleshoot voice over IP equipment in an enterprise call control and session management platform
Determine the tip-ring and low voltage wiring color code for voice functionality

Fulltime

New

Lead Telecomm Operator, PBX Services

The Lead Operator will operate efficiently and train other operators on the Hosp...

Location

United States , Miami

Salary:

16.00 - 18.84 USD / Hour

Baptist Health

Expiration Date

Until further notice

Requirements

High School Diploma, Certificate of attendance, GED, or Experience
Minimum of 2 years customer service experience
Excellent communication and computer skills with knowledge of office practice and use of standard office equipment
Must be able to manage multiple tasks requiring immediate attention
Must be able to work in a high energy, fast paced environment
Ability to work well under pressure

Job Responsibility

Operate efficiently and train other operators on the Hospital switchboard
Ability to operate multiple-position telephone switchboard to relay incoming, outgoing, and interoffice calls
Performs miscellaneous hospital Telecommunications and clerical duties
Monitors all hospital alarms, performs code paging, and also provides callers with patient information
Assumes the duties of the Consumer Access Operator Supervisor in their absence
Consistently delivers exceptional service to patients, guests, and fellow co-workers

What we offer

Career growth and development opportunities
Comprehensive health and wellness resources
Wellness program that can help employees eliminate their medical plan deductible
Tuition reimbursement

Fulltime

New

Medical Assistant 2, MNI NeuroPsych - Office

Works under the clinical supervision of the practice physician(s) and clinic sup...

Location

United States , Miami

Salary:

21.24 - 27.61 USD / Hour

Baptist Health

Expiration Date

Until further notice

Requirements

High School,Cert,GED,Trn,Exper
Licensed Practical Nurse
Paramedic
AAMA Certified Medical Assistant
Emergency Medical Technician
Certified Nursing Assistant
Basic Life Support
Registered Medical Assistant
Must have at least one of the above required licenses/certifications (MA, CNA, LPN, EMT, Paramedic)
Medical Assistants with a Certificate or Diploma of Completion of a Medical Assistant training program hired after 7/1/16 or foreign Medical Doctor with a foreign medical doctor diploma hired after 5/1/17 will have up to 6 months from start of employment with BHSF to obtain Medical Assistant Certification

Job Responsibility

Works under the clinical supervision of the practice physician(s) and clinic supervisor/manager and is responsible for assisting the physicians in the practice
Assists in examination and treatment of patients, rooms patients and obtains information, measures vital signs (i.e.: pulse rate, temperature, blood pressure, pulse oximeter, pain level, weight, and height), and records information on patients' charts/Electronic Medical Record (EMR)
Collects and prepares specimens for laboratory analysis

What we offer

$3000 Bonus
Career growth and development opportunities
Comprehensive health and wellness resources
A wellness program that can help employees eliminate their medical plan deductible
Tuition reimbursement

Fulltime

New

Athletic Trainer 1

Works under the clinical supervision of the practice physician(s) and office man...

Location

United States , Coral Gables

Salary:

26.13 - 33.97 USD / Hour

Baptist Health

Expiration Date

Until further notice

Requirements

Bachelors
NATA Certified Athletic Trainer
Licensed Athletic Trainer
Automated External Defibrillator Certification
Basic Life Support
Professional, detail-oriented team player with effective interpersonal communication skills
Confidentiality a must
Proficient in computer applications and typing skills
High ethical standards, HIPAA /OSHA compliance required

Job Responsibility

Assisting the physician and advanced practice providers in the practice
Communicates regularly with patients
Demonstrates sufficient knowledge and skills to perform basic duties in the office clinic
Has the added responsibilities of being assigned to a provider and/or service line
Practices Baptist Health's mission of service excellence in providing professional, compassionate and friendly service to our patients and physicians

What we offer

Career growth and development opportunities
Comprehensive health and wellness resources
Wellness program that can help employees eliminate their medical plan deductible
Tuition reimbursement
$10000 Bonus

Fulltime

New

Tax Manager

We are looking for a Tax Manager to join a client-focused team in Bloomington, M...

Location

United States , Bloomington

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

At least 2 years of progressive accounting experience, including direct interaction with clients
Working knowledge of bookkeeping, financial statement preparation, and core tax principles for business and individual matters
Experience overseeing accounting workflows, with prior team coordination or leadership exposure preferred
Familiarity with accounting and tax applications such as QuickBooks, Drake Tax Software, and related reporting tools
Ability to prepare or review tax returns, including individual filings and annual income tax provision support
Strong analytical and organizational skills with the ability to manage several priorities in a deadline-sensitive environment
Clear written and verbal communication skills for effective collaboration with clients, colleagues, and external partners
Self-directed approach to work, including the judgment to identify issues early and escalate concerns when appropriate

Job Responsibility

Direct accounting activities for assigned clients, ensuring records, reconciliations, and deliverables are completed accurately and on schedule
Evaluate monthly financial reports and related statements, identifying discrepancies, trends, and areas that require follow-up
Manage engagement timelines and service expectations while keeping clients informed about required documentation, milestones, and upcoming deadlines
Review financial activity to uncover reporting issues, resolve account concerns, and recommend practical improvements to clients and internal teams
Guide new client implementations by helping establish workflows, configuring processes, and supporting early-stage account management needs
Contribute to the preparation and review of business and individual tax returns, helping maintain quality and compliance across filings
Coordinate tax calendars and related workstreams to ensure submissions, planning activities, and client responses are completed within required timeframes
Address tax notices and other correspondence by gathering information, preparing responses, and following matters through resolution
Support improvements to accounting and tax technology by assisting with software updates, working with external vendors, and identifying ways to strengthen reporting efficiency
Assist with special assignments such as cash flow reviews, forecasting support, and other client service or operational projects as needed

What we offer

Medical, vision, dental, and life and disability insurance
401(k) plan
Free online training

Fulltime

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Regulatory Affairs Associate - Advertising & Promotional Labeling

Job Description

Job Responsibility

Requirements

What we offer

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