| Job List |
| Job ID: |
TA-03189-2 - Clinical Trial Manager |
| Description: |
• Conducts strategic assessment (gap analysis) of information needs within the therapeutic area and develops fulfillment strategies (e.g., publication/research planning, educational activities, attendance at key medical meetings and advisory boards, etc.);
• Provides expert clinical and technical product knowledge in response to clinical/medical inquiries from external and internal customers;
• Serves as a member of the advertising/promotional review committee representing Global Medical Affairs (GMA), and provides editorial input related to product line/therapeutic area;
• Develops/executes internal and external education/internal training programs with respect to medical/clinical issues within the product line/therapeutic area;
• Possesses an advanced understanding and maintains current knowledge of regulatory and quality requirements;
• Possesses/maintains a current familiarity of the published medical literature relating to the product line/therapeutic area and serves as a resource regarding clinical trends and their potential impact;
• Leads planning, development, and execution of product launches. Activities may include writing/amending package inserts, licensing submissions, and development of training materials;
• Participate in post-market research initiatives including development of safety surveillance registry protocols, study database analyses, and reporting;
• Develops strategies and initiatives that improve and streamline current processes within GMA to improve scientific data and communications services to internal and external customers;
• Oversees product development including clinical appropriateness reviews.
Provides clinical expertise within an individual therapeutic unit and clinical knowledge for the entirety of the product line(s) related to that therapeutic unit. Leads strategic assessment, planning, and execution of scientific communications, post-market research initiatives, and supervises/trains employees within the therapeutic area. Provides medical/clinical expertise related to products to internal (marketing, manufacturing, quality assurance, regulatory affairs, R&D, and legal) and external (healthcare professionals, patients, advocacy groups, etc.) customers from the U.S. and abroad, and assists in resolution of product queries/complaints. Reviews/approves advertising and promotional, as well as scientific and educational, materials within the therapeutic area.
Advanced degree required (PharmD, PhD, MD) plus 2+ years experience in a pharmaceutical, medical device, or biotech company preferred. Supervisory or clinical experience is highly desirable, with familiarity with ICH guidelines/GCP. Knowledge of hemophilia, as well as biopharmaceuticals used to treat immune deficiencies, alpha 1 antitrypsin deficiency and other blood-related disorders therapeutic areas is helpful.
Must possess interpersonal skills and a demonstrated ability to manage conflict situations as well as a demonstrated record of responsible actions. Must also have excellent verbal/written communication skills, excellent presentation and teaching skills, be computer literate, and able to participate in a cross-functional team approach. Ability to influence, initiate, and accept change, and address complex, multi-faceted questions and issues. Demonstrates exceptional follow-through with respect to tasks and projects.
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Salary: 135k,
Job Type: Permanent,
Total Exp: 5-10 Yrs,
Start Date: ASAP,
Location: Chicago, IL |
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| Job ID: |
TA-03189-1 - Medical Affairs Manager |
| Description: |
Our client is a pharmaceuticals company that is publicly traded. It is a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products for serious conditions of the eye.
In order for our client to further build their pipeline as a specialty pharmaceutical company, they expect to acquire complementary products in ophthalmology, either already marketed or in late-stage development. Their management team has extensive experience in the development and commercialization of ophthalmic pharmaceuticals. Their Ophthalmology expertise can be found in the Marketing, Sales, Manufacturing, Clinical, Regulatory and General Management functions.
If you thrive on the challenge of launching products, and the rewards of exceeding revenue targets while building a successful company, we welcome your response!
The successful candidate will report directly to the Director, Medical Affairs. As a key member of the Medical Affairs team, the Medical Affairs Manager serves as an extension of Medical Affairs in their region. They contribute to the overarching strategy and tactics that are important to assuring the proper direction and success of the departments efforts.
Specific job responsibilities include but are not limited to: identifying and communicating ideas from thought leaders that are important for clinical and research initiatives, development, support and delivery of regional medical education programs, speaker development, identification of sites and opportunities for company sponsored and investigator initiated clinical trials, providing professional support to regional sales on medical and clinical issues, and competitive intelligence. The position requires a highly energetic professional who can deliver consistent results in a constantly changing and relatively unstructured daily environment.
Duties & Responsibilities:
Primary Responsibilities
• Medical affairs customer relations management with key national and regional opinion leaders and centers of influence.
• Support, development / delivery of regional medical education programs
• Speaker development and maintenance
• Phase 3b / 4 research trial site support and investigator initiated research proposal cultivation and facilitation.
• Scientific support at key regional and national congresses
• Competitive intelligence gathering and assimilation
• Responding to unsolicited off-label requests that require personal communications
• Hospital formulary, regional managed care and government account support and presentations.
Other Responsibilities
• Sales force support dictated by the magnitude medical and scientific rigor required
• Regional sales force medical and scientific product related training
• Territory management
Additional Dimensions:
• Customer relationship management skills
• Goal development / Business planning / Execution / Documentation
• Platform, small group moderator and one on one presentation skills
• Development and delivery of reports and Business reviews utilizing MS word, Excel, and PowerPoint.
Qualification Requirements:
Education & Experience
• Terminal Doctorate Degree (Pharm.D., M.D., Ph.D)
• Experience as liaison in pharmaceutical industry preferred.
• Post-graduate teaching and training preferred
Knowledge & Abilities
• Firm background in scientific methodology, general pharmacology and therapeutics
• Understanding of basic clinical research and statistics
• Demonstrated excellent commutations and presentation skills
Physical Demands and Work Environment
• Ability to travel overnight
• Ability to drive up to 3 hours
• Ability to organize and work within a home office environment
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Salary: 140k,
Job Type: Permanent,
Total Exp: 4 yrs,
Location: South Central U.S. |
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| Job ID: |
CIR-06128-1 - Regional CRA - Los Angeles |
| Description: |
The Regional CRA manages the implementation of study protocols at research sites. Responsibilities include but are not limited to: serving as a CRA for clinical studies; performing monitoring visits including site qualification, initiation, monitoring and closeout visits; developing monitoring plan; maintaining contact with study sites, report preparation and communications documentation; conducting training; preparing for and participating in Sponsor and FDA audits; managing clinical project assistants and associates.
Required qualifications: BA/BS degree or equivalent combination of education and experience in a medical or scientific discipline; minimum 1 year regional monitoring experience; significant technical, medical or industry experience in a clinical research setting; strong understanding of Medical Terminology, Physiology, and Pathophysiology; working knowledge of Good Clinical Practices; strong organizational skills; the ability to multi-task and work effectively in a fast-paced environment; strong written and verbal communication and diplomacy skills; professional demeanor and appearance; ability to travel.
Preferred qualifications: BS in scientific discipline; 2+ years experience in a CRO. They will consider an experienced CRC with oncology experiencefor this position.
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 2-4 Yrs,
Location: Los Angeles |
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| Job ID: |
CIR-04071-9 - Regional CRA - West Coast |
| Description: |
The Regional CRA manages the implementation of study protocols at research sites. Responsibilities include but are not limited to: serving as a CRA for clinical studies; performing monitoring visits including site qualification, initiation, monitoring and closeout visits; developing monitoring plan; maintaining contact with study sites, report preparation and communications documentation; conducting training; preparing for and participating in Sponsor and FDA audits; managing clinical project assistants and associates.
Required qualifications: BA/BS degree or equivalent combination of education and experience in a medical or scientific discipline; minimum 1 year regional monitoring experience; significant technical, medical or industry experience in a clinical research setting; strong understanding of Medical Terminology, Physiology, and Pathophysiology; working knowledge of Good Clinical Practices; strong organizational skills; the ability to multi-task and work effectively in a fast-paced environment; strong written and verbal communication and diplomacy skills; professional demeanor and appearance; ability to travel.
Preferred qualifications: BS in scientific discipline; 2+ years experience in a CRO. They will consider an experienced CRC with oncology experiencefor this position.
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 2-4 Yrs,
Location: California |
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