External Comms Associate Director

Description:

• 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.
• 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

Qualifications:

• Life Sciences Masters degree in an appropriate discipline.
• Desirable: Advanced degree in a scientific discipline (Ph.D.).
• Minimum 5 years of relevant experience for Bachelor's/Master's candidates.
• 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
• Pharmaceutical industry experience is required.
• Regulatory writing
• Clinical study protocols
• Clinical study reports (CSRs)
• Medical/clinical authoring experience

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.