Regulatory Affairs Specialist - Pharma Advertising And Promotion
Company Name:
Pharthenogene
Seeking individual with experience interfacing directly with officials from the FDA Office of Prescription Drug Promotion (OPDP).
Shall:
Review advertising and marketing materials to ensure submission forms meet regulatory compliance criteria.
Communicate with key decision makers in the Office of Prescription Drug Promotion.
Review and approve all documents and forms including FDA Form-2253 before final submission.
Interface with cross-functional teams including Medical Affairs, Legal, Commercial and Business Development.
Qualifications:
B.S. or M.S. in Health or Life Sciences, Pharm.D. or J.D.
Minimum 5
years experience in regulatory review and approval for promotional materials in a pharmaceutical company.
Strong knowledge of regulatory submission processes and associated systems.
Join an industry leader as a key contributor to the release of new, high-profile therapeutic solutions. Frequent interaction with FDA members and industry executives. Steady growth opportunities and stable company. Competitive, industry leading salary and executive benefits package and perquisites including stock, matched 401(k), travel reimbursement, pension and retirement plans. Paid time off from start and attractive vacation packages.
For complete details contact Winston F. Reuning at:
(609) 584-9000 ext 230
Or submit resume online at:
Or email to:
Please reference #3609911 when responding
Education Requirements: Master Degree
Minimum Experience Requirements: 5-10 years
Job City Location: Berkeley Heights
Job State Location: NJ
Job Country Location: USA
Salary Range: $150,000 to $230,000
WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES:
Disclaimer: We will make every effort to consider applications for all available positions and shall use one or more of the contact methods and addresses indicated in resume or online application. Indicated location may be proximate or may be desirable point of embarkation for paid or unpaid relocation to another venue. Job descriptions may fit single or multiple presently available or anticipated positions and are NOT an offer of employment or contract implied or otherwise. Described compensation is not definite nor precise and may be estimated and approximate and is negotiable depending on market conditions and candidate availability and other factors and is solely at the discretion of employers. Linguistics used herein may use First Person Singular and First Person Plural grammatical person construction for and with the meaning of Third Person Singular and Third Person Plural references. We reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Response to a specific posting or advertisement may result in consideration for other opportunities and not necessarily the incentive or basis of the response. Nothing herein is or may be considered a promise, guarantee, offer, pledge, agreement, contract, or oath.
If you submit an application or resume which contains your email address, we will use that email address to communicate with you about this and other positions. We use an email quality control service to maintain security and a remove and dead address filter. To cancel receiving email communications, simply send an email from your address with the word remove in the subject line to Or, visit the website at .Estimated Salary: $20 to $28 per hour based on qualifications.
Pharthenogene
Seeking individual with experience interfacing directly with officials from the FDA Office of Prescription Drug Promotion (OPDP).
Shall:
Review advertising and marketing materials to ensure submission forms meet regulatory compliance criteria.
Communicate with key decision makers in the Office of Prescription Drug Promotion.
Review and approve all documents and forms including FDA Form-2253 before final submission.
Interface with cross-functional teams including Medical Affairs, Legal, Commercial and Business Development.
Qualifications:
B.S. or M.S. in Health or Life Sciences, Pharm.D. or J.D.
Minimum 5
years experience in regulatory review and approval for promotional materials in a pharmaceutical company.
Strong knowledge of regulatory submission processes and associated systems.
Join an industry leader as a key contributor to the release of new, high-profile therapeutic solutions. Frequent interaction with FDA members and industry executives. Steady growth opportunities and stable company. Competitive, industry leading salary and executive benefits package and perquisites including stock, matched 401(k), travel reimbursement, pension and retirement plans. Paid time off from start and attractive vacation packages.
For complete details contact Winston F. Reuning at:
(609) 584-9000 ext 230
Or submit resume online at:
Or email to:
Please reference #3609911 when responding
Education Requirements: Master Degree
Minimum Experience Requirements: 5-10 years
Job City Location: Berkeley Heights
Job State Location: NJ
Job Country Location: USA
Salary Range: $150,000 to $230,000
WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES:
Disclaimer: We will make every effort to consider applications for all available positions and shall use one or more of the contact methods and addresses indicated in resume or online application. Indicated location may be proximate or may be desirable point of embarkation for paid or unpaid relocation to another venue. Job descriptions may fit single or multiple presently available or anticipated positions and are NOT an offer of employment or contract implied or otherwise. Described compensation is not definite nor precise and may be estimated and approximate and is negotiable depending on market conditions and candidate availability and other factors and is solely at the discretion of employers. Linguistics used herein may use First Person Singular and First Person Plural grammatical person construction for and with the meaning of Third Person Singular and Third Person Plural references. We reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Response to a specific posting or advertisement may result in consideration for other opportunities and not necessarily the incentive or basis of the response. Nothing herein is or may be considered a promise, guarantee, offer, pledge, agreement, contract, or oath.
If you submit an application or resume which contains your email address, we will use that email address to communicate with you about this and other positions. We use an email quality control service to maintain security and a remove and dead address filter. To cancel receiving email communications, simply send an email from your address with the word remove in the subject line to Or, visit the website at .Estimated Salary: $20 to $28 per hour based on qualifications.
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