Assistant/Associate Scientific Director
- Employer
- AbbVie
- Location
- Irvine, CA, United States
- Start date
- Jan 21, 2021
View more
- Discipline
- Clinical, Medical Affairs
- Required Education
- Associate Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Associate/Assistant Scientific Director, Medical Affairs
Job Description
T he Associate/Assistant D i r e c t o r , M e d i c a l A f f a ir s has a k ey role w it h i n the BOTOX Therapeutic & Migraine T h e r ape u t i c A r ea . Wo r k i ng under t he l e ad e r s h i p of t h e Scientific Director/Medical Director, t h i s leader supports the development and execution of the migraine m e d i c a l s tr a t e g y, specifically as it pertains to onabotulinumtoxinA (BOTOX) in Migraine by providing scientific, strategic and operational input into core medical affairs activities including thought leader engagement plans and field provider interactions; generation and dissemination of clinical and scientific data; provider and payer educational initiatives and promotional material generation, this leader ensures tactical execution is r e l e v ant t o t he market - ph y s i c i an s , pa ti e n t s and p a y o r s.
The Associate/Assistant Di r e c t o r , M e d i c a l A ff a ir s m ust cond u ct t h e i r w o r k ac ti v i ti e s i n c o m p li a n ce wi t h a l l AbbVie i n t e r n a l r e qu i r e m en t s a nd wi t h a l l app l i ca b l e US r e g u l a t o r y r eq u i re m en t s. AbbVie i n t e r n a l r e qu i r e m en t s i n c l u de co m p l i a nce wi t h e t h i c s , en v ir on m en t a l he a l t h and s a f e t y , fi n a nc i a l , hu m an r e s ou r c e s , and g ene r al bu s i n e ss p o l i c i e s , r eq u i r e m en t s, a nd ob j e c t i v e s .
T he e m p l o y ee i s expe c t ed t o be f u ll y c a pa b l e o f p e rf or m i ng r o l es enco m pa s s ed i n t he p r e c ed i ng g r ade l e v e l s w it h i n t h e j ob f a m il y as r e q u i r ed by t h e o r g an i z a t i on. A d d i ti o n al ac t i v it i e s , sp e c i a l p ro j e c t s a nd a s s i g n m en t s m a y be g i ven, as r eq u ir e d. A s a r e su l t , t he p e r c e n t a g e o f t i m e s pent ac r oss k ey du ti e s a nd r e spon si b i l i t i es w i l l v a r y depen d i ng on p r o j e c t a s s i g n m en t s, t he r ape u t i c ar ea ne e ds a nd t h e r equ i r e m en t s w i t h i n the T h e r ape u t i c A r ea.
Key Responsibilities
- With oversight, contributes to the development of medical migraine strategy for BOTOX in Migraine.
- Contributes to the development of and leads the execution of the medical education tactics, advisory boards, and thought leader engagement plan in line with atogepant strategic plan.
- Leads the US Conference planning and execution.
- May be responsible for Medical Review (MR) training for on label, clinical data and disease state for atogepant.
- Responsible for managing budget for assigned projects including consulting and vendor management.
- Supports clinical and scientific data generation including alignment of the Investigator Initiated Study (IIS) strategy as needed to support external communication
- Provides subject matter expertise for MSL, health outcomes and commercial teams including competitive assessments and regular scientific literature reviews.
- Aligns medical education and scientific initiatives with atogepant Scientific Communication Platform
- Contributes to the strategic and leads annual medical tactical planning initiatives.
- Contributes to the generation of Medical Information (MI) communication content and supports training on MI materials.
- Contributes to all launch readiness reviews/planning.
Qualifications
Education and Experience
- M e d i c a l de g r ee, Ph D , Ph ar m D and / or o t h er h i g her s c i en t i f i c d e g r e e. P r e f e r a b l y ' boa r d c e r t i f i ed s p ec i a l t y qua l i f i c a ti on' or eq u i v a l e n t a n d ph a r m aceu ti c al i nd u s t r y r eco g n i z ed q ua l i f i c a ti on e. g . MSc
- At least 3-5 y ea r s of b i oph a r m aceu t i c a l / m ed i cal de v i c e i n du s tr y e x pe r i en c e , i n c l u d i ng substantial understanding of relevant therapeutic area required.
E sse n t i a l S k i l l s a nd A b i l iti e s
- Should ha v e a good un d e r s t a nd i ng of l e g al a n d r e g u l a t or y g u i de l i nes ( e. g . k no w l ed g e of O P D P p r o m o ti on a l r e g u l a ti o n s, CD E R / CB ER r e g u l a t i ons a s t hey r e l a t e t o d r ug app r o v a ls) .
- G ood und e r s t an d i ng of G o od C li n i c al P r a c t i ces, I C H g u i de l i ne s , P h R MA co d e, F D A C F R , I S O , c li n i c al r e se a r ch e t h i c s , H I P A A and pa t i e n t p ri v acy l aws, EU D ir e c t i v e and o t her ap p li c ab l e l oc a l r e g u l a t i ons
- G ood und e r s t an d i ng of Me d i c a l A f f a ir s p r i n c i p l e s , s t u dy de si g n and pu b l i c a ti o n s.
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.
- Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc.
- Ability to interact externally and internally to support global business strategy.
- Ability to work effectively with different cross functional groups and have strong interpersonal and communication skills. (both oral and written)
- Able to coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects.
- Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc.
- Pro f i c i ent w i th e l e c tr o n i c sy s t e m s i nc l u d i n g M i c r os of t O f f i c e Su i t e, S h a r ePo i n t , v i deocon f e r en c i ng p l a t f o r m s
- A b i l it y t o h and l e and p r i o r i ti z e m u lti p l e p r i o r i t i es
- Se lf - s t a r t e r wi t h a b i li t y t o w o r k i ndepe n de n tl y w it h r e m o t e or m i n i m al sup er v i s i o n
- A b i l it y t o w o r k e ff e c t i v e l y i n a t ea m / m a tri x en v ir on m ent
- A b i l it y t o i n f l ue n ce o t h e r s w it ho u t d ir e ct r ep o r t i ng r e l a t i ons h i ps
- Works with some supervision and guidance. Exercises judgment within well-defined practices and policies.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Significant Work Activities
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 15 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Company
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.
Stock Symbol: ABBV
Stock Exchange: NYSE
- Website
- http://www.abbvie.com/
- Phone
- 1-800-255-5162
- Location
-
1 North Waukegan Road
North Chicago
Illinois
60064
US
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