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Remote General Medicine Rare Diseases Medical Affairs Medical Director

Posted almost 2 years ago

Vacancy Name Medical Director, General Medicine/Rare Diseases Medical Affairs (Remote), US

Vacancy No VN2473

Employment Type Regular

Location Country United States

Location City Boston

Detailed Description

SUMMARY:

To provide medical management and professional medical support for clinical research projects at WORLDWIDE as the assigned Medical Monitor (MM). To assist in activities requiring Medical support, including but not limited to: assistance with feasibility assessments, medical training and provision of medical/clinical input to the design of study protocols and/or clinical development programs as well as assistance with business development activities, as directed by the department head.

LOCATION: This role can be home based anywhere in US.

RESPONSIBILITIES:

Tasks may include but are not limited to:

Medically manages clinical trials to which s/he is assigned as MM

Serves as Global Lead MM (GLMM) for pan-regional and/or global trial(s) to which s/he is assigned

Collaborates with the other members of the Medical & Safety project teams to process Serious Adverse Events (SAEs)

Provides therapeutic and protocol-specific training to the project teams

Contributes medical input into the design of clinical development programs, study protocols, research papers, client focused white papers, etc

Provides after hours medical support for projects to which s/he is assigned

As directed supports Business Development through participation in proposal generation, feasibility assessments, review of proposals/contracts for medical services, and attendance at meetings with sponsors as directed by department senior management

Reviews and/or assist in the preparation of final study reports (CSRs), or other study documentation (Protocols, ISS/ISEs etc,) as directed by senior management

Maintains a high level of competence with assigned projects, including knowledge of project and therapeutic advances as well as marketplace developments by participating in internal meetings (company-wide project tracking, medical management meeting, etc) , review of relevant therapeutic/clinical literature and attendance in conferences and meetings

Interacts with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects

Identifies, documents and appropriately resolves out-of-scope work as directed by senior management

Assists in the annual attainment of departmental revenue targets and any other activities as directed by senior management

Maintains working knowledge of GCPs and regulatory requirements relating to clinical development and safety assure compliance with ethical, legal and regulatory standards

Assists in the mentoring of other medical staff) as directed by Senior management and by consistently displaying exemplary work ethics, compassion and integrity, supports Senior Management's leadership of both the department and the company

Maintains clinical/therapeutic acumen in medical subspecialty through online and/or in person scholarly programs/lectures

Demonstrates competence with the execution of SAE related medical review in WORLDWIDEs electronic safety database

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

OTHER SKILLS AND ABILITIES:

Excellent computer skills (Word, Excel, Access)

Excellent spoken and written English skills

Excellent organizational and time management skills

Excellent communication skills

Excellent presentation skills

REQUIREMENTS:

Medical Degree from an accredited institution of Medical Education.

At least 2 years of medical monitoring in clinical research or related industry

Valid passport and ability to travel as required.

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

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