External Comms Associate Director

Job Title – External Comms Associate Director

Location – Boston MA 02210

Duration – 12 months contract (With the possibility of extension)

Shift - M-F Hours: 8-4pm or 9-5pm

Position Overview:

• The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices.
• We support the Company’s core therapeutic areas in all phases of clinical development.
• Our vision is to be an industry leading organization driving strategic communication excellence to achieve successful submissions and approvals.

The Clinical Regulatory Writing Associate Director is expected to:

• Independently manage clinical regulatory writing activities across a complex portfolio of work.
• Author the most complex clinical-regulatory documents within a program by ensuring that relevant regulatory, technical and quality standards are achieved, and that relevant processes and best practice are applied.
• As part of a clinical delivery or submission team, provide strategic communications leadership to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency.
• When acting as a submission lead, drive the development of the clinical Submission Communication Strategy (cSCS).
• Lead internal/external authoring teams and provide strong partnership with vendor medical writers to ensure delivery to time and quality.
• Drive the clinical interpretation of complex data and information and condense it into clear, concise and accurate messages that address customer information requirements.
• Be a strategic thinker and demonstrate strategic review capabilities.
• Proactively collaborative with other functions at the program level.
• Support the development of Clinical Regulatory Writing Managers.
• Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non-drug projects, as required Education, Qualifications

Skills and Experience Essential:

• Life Sciences masters degree in an appropriate discipline.
• Significant medical writing experience in the pharmaceutical industry or CRO.
• Ability to advise and lead communication projects.
• Understand drug development and communication process from development, launch through life cycle management.
• In depth knowledge of the technical and regulatory requirements related to the role

Desirable:

• Advanced degree in a scientific discipline (Ph.D.).

Company Overview:

• Infojini Consulting is a Staffing and Recruitment company and incorporated in Baltimore, MD.
• Infojini caters various hospitals, health & wellness centers, pharmacy, and medical facilities over fifty states across the United States.