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Clinical Regulatory Writing Associate Director

Ampcus Inc

Gaithersburg, Maryland • Today

Easy Apply

Contract

$65 - $75

Clinical Contracts Associate

Arnex Solutions LLC

Remote • Today

Full-time, Third Party

Depends on Experience

Job Details

Skills

Life Sciences
Medical Writing
Pharmaceutical Industry
Strategic Communication
Drug Development
regulatory requirements
life cycle management
submission

Summary

Description:

Typical Accountabilities

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.).

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10115448
Position Id: 26-13288
Posted 6 hours ago

Fitment

Dice Job Match Score™

🎯 Assessing qualifications...

Contact the job poster

Sunil Baviskar

Recruiter @ Ampcus Inc

View Profile

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Job Details

Skills

Life Sciences
Medical Writing
Pharmaceutical Industry
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regulatory requirements
life cycle management
submission

Summary

Description:

Typical Accountabilities

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.).

Dice Id: 10115448
Position Id: 26-13288
Posted 6 hours ago

Fitment

Dice Job Match Score™

🎯 Assessing qualifications...

Contact the job poster

Sunil Baviskar

Recruiter @ Ampcus Inc

View Profile

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

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