Head of Medical Writing, Director through Executive Director level

Requisition Number: 2774

Position Title: Senior Director, Medical Writing

External Description:

SUMMARY: In this role the Head of Global Medical Writing will direct the overall operation of the growing Medical Writing team for Worldwide Clinical Trials Globally. S/he will develop an organizational structure, recruit and manage staff to ensure excellence in performance and establish quality parameters for the Medical Writing deliverables. S/he will train and motivate staff with a proactive educational approach. S/he will develop and manage operating budgets for the department and individual projects. The ideal candidate will identify and develop business opportunities involving new Medical Writing projects and opportunities including business improvements in order to further build the successful reputation for the team. This will involve interface with Business Development department and other departments as needed regarding Sponsor presentations and new project bids. S/he will attend relevant FDA, industry and scientific meetings and maintain relationships with industry contacts.

 
RESPONSIBILITIES:

• Recruit, lead, develop and mentor, to further build a strong team that has a reputation for successful delivery of Medical Writing expertise globally
• Plan and implement improvements to ensure that the group is able to deliver effectively to meet and exceed study objectives on behalf of sponsors.
• Organize and maintain the resourcing for global projects
• Liaise with sponsors, clinical project managers, and business development personnel in order to advise on the delivery of study objectives
• Develop and consistently manage the budget to ensure financial objectives are met, providing new business cost estimates when required
• Identify and develop business opportunities involving new Medical Writing projects and opportunities for the company and interface with Business Development department and other departments as needed to successfully conduct Sponsor presentations and new project bids
• Attend relevant FDA, industry and scientific meetings and maintain relationships with industry contacts

 
REQUIREMENTS:

 

• BS/BA (scientific discipline preferred) or equivalent with 8 or more years relevant experience in the pharmaceutical industry or an advanced degree with 5 years relevant experience
• Experience leading a Medical Writing team including deep understanding of departmental and project finances
• Comprehensive knowledge of drug development, including ICH and regulatory guidelines
• Demonstrates core values of integrity, teamwork, excellence, accountability, tenacity
• Skilled in communicating with all levels including potential clients and corporate leaders
• Strong management skills, including the ability to supervise and evaluate departmental personnel
• Passionate about innovation and leadership in developing new ideas related to Medical Writing.
• Previous experience developing process improvements, SOPs and creating efficiencies where none existed previously.
• High degree of self-motivation and the ability to work efficiently and independently across several countries
• Ability to motivate others and to provide clear and comprehensive coaching
• Good understanding of experimental methods, research design, and statistical analysis
• Advanced scientific, technical reading, writing, and editing skills
• Attention to detail—style, consistency, grammar, syntax, scientific accuracy
• Ability to accurately interpret data and express findings in a clear and concise written manner
• Proficient in medical writing software and related tools

 

 

 

 

 

#LI-EW1 #LI-Remote

City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Head of Medical Writing, Director through Executive Director level

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Belgrade, Vojvodina RS

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