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AstraZeneca · 7 hours ago

Clinical Regulatory Writing Manager (Associate Director)

Boston, MA

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$133K/yr - $200K/yr

7+ years exp

AstraZeneca is a company focused on turning drug development strategies into reality. As an Associate Director in Clinical Regulatory Writing, you'll manage clinical regulatory writing activities, author complex documents, and provide strategic communications leadership to drug projects.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

Responsibilities

Independently manage clinical regulatory writing activities across a complex portfolio of work

Author the most complex clinical-regulatory documents within a program, ensuring regulatory, technical, and quality standards are met

Provide strategic communications leadership to projects, establishing communication standards and advocating for quality and efficiency

Drive the development of the clinical Submission Communication Strategy (cSCS) when acting as a submission lead

Lead internal/external authoring teams and partner with vendor medical writers to ensure timely and quality delivery

Interpret complex data and information, condensing it into clear, concise messages that meet customer information requirements

Demonstrate strategic thinking and review capabilities

Collaborate proactively 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

Qualification

Medical writingClinical regulatory documentsDrug development knowledgeCommunication leadershipLife Sciences degreeContinuous improvementStrategic thinkingCollaboration

Required

BS Life Sciences degree in an appropriate discipline

Significant (7+ yrs) 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

Preferred

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

Benefits

Qualified retirement programs

Paid time off (i.e., vacation, holiday, and leaves)

Health, dental, and vision coverage in accordance with the terms of the applicable plans

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees