Associate Director, Clinical Regulatory Writing; CReW

Associate Director, Clinical Regulatory Writing (CReW)

We are recruiting an Associate Director, Clinical Regulatory Writing (CReW). 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.

• 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.
• 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 others in Clinical Regulatory Writing.
• Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non‑drug projects, as required.

• Bachelor's degree in Life Sciences in an appropriate subject area
• Minimum of 5 years’ experience
• 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.

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

The annual base pay for this position ranges from $ - $ USD Annual. Base pay offered may vary depending on multiple individualized factors, including market location, job‑related knowledge, skills, and experience. In addition, 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.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.