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Associate Director - Regulatory Affairs Advertising & Promotion Job
Eingestellt von Yoh
Gesuchte Skills: Marketing, Support, Sales
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
- Regulatory Affairs
- Advertising and Promotion
WHAT YOU'LL BE DOING:
- Manage regulatory aspects of Post-Marketing regulatory submissions and communications with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) [formerly the Division of Drug Marketing, Advertising and Communications (DDMAC)).
- Develop regulatory, strategic, and compliance plans for maximizing the commercial aspects for the marketing of client's products. Manage timelines and resources to achieve stated goals.
- Advise the Corporation on relevant new and existing regulatory risk and compliance requirements and provide regulatory expertise, advice, and support to Sales & Marketing and other product-related teams and the Copy Review Committee (CRC). Foster and facilitate teamwork between GRA and these allied functions.
- Contribute to the development and implementation of Corporate and Department procedures and policies for regulation of marketed promotional materials and press releases.
- Provide leadership for and manage regulatory aspects of the copy review/approval process for product promotional materials, maintain compliance of promotional materials with the governing FDA regulations, and submit promotional materials to OPDP in a timely fashion.
- Monitor and interpret promotional labeling regulations and guidelines for the successful and compliant commercial marketing of client's pharmaceutical products. Pro-actively monitor the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape.
- Provide colleagues in GRA and allied functions with cutting edge guidance on requirements and changes.
- Foster collaborative, efficient, and effective working relations with FDA in order to further build the cordial working relationship between client and FDA.
- Work closely with the GRA rep on Project Teams to support A&P Activities.
WHAT YOU NEED TO BRING TO THE TABLE:
- BS or MS in scientific discipline or equivalent. Advertising and Promotional experience is a MUST.
- Five to nine (5 - 9) years of pharmaceutical industry experience, including three to five (3 -5) years in regulatory affairs. Preference for at least three (3) years experience in post-marketing regulatory affairs, specifically pharmaceutical promotional activity.
- Knowledge of Advertising and Promotional FDA regulations and experience with FDA communication and contact is necessary.
- Excellent interpersonal skills and written and oral communications skills.
- Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously.
- Must be able to innovate, analyze, and solve problems with minimal supervisory input.
- Able to accommodate modest amount of domestic travel.
- Ability to manage multiple responsibilities with high degree of self-motivation.
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Hannah Cihlar
Yoh, a DayJ2W: PROF
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Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Warren, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Marketing/Vertrieb, Sonstiges