Associate Director, R&I Clinical Regulatory Writing (CReW)

What You will Do

• Independently manage clinical regulatory writing activities across a portfolio of work.
• Author 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.
• Drive the development of the clinical Submission Communication Strategy.
• 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 information requirements.
• Be a strategic thinker and demonstrate strategic review capabilities.
• Proactively collaborate with other functions at the program level.
• Support the development of others in Clinical Regulatory Writing.
• Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the Clinical Regulatory Writing function on drug and non-drug projects, as required.

Minimum Qualifications

• A Bachelor's degree
• At least 5 years of experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or Contract Research Organization environment.
• Experience leading submission authoring and authoring submission level documents.
• Understanding of the drug development process from development through life-cycle management.
• Experience in working within, and contributing to, large, diverse, matrix teams.
• Excellent verbal and written communication skills in English.
• In depth knowledge of the technical and regulatory requirements related to the role.
• Flexibility in adapting to changing circumstances and latest information.

Desirable Qualifications

• An advanced degree in a scientific discipline (Ph.D.)

Benefits

Our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

Benefits offered include a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.