Description:

FULLY REMOTE (Pacific Standard PST Time Zone)

Regulatory Writing Manager

In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards.

-Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development phases 1-4

-Write CTD sections including the Summary of Clinical Efficacy Summary of Clinical Safety Summary of Clinical Pharmacology Summary of Biopharmaceutics Clinical Overview Table of All Studies briefing documents and safety narratives

-Write other regulatory submission documents eg RTQs PIPs white papers breakthrough therapy applications orphan drug applications

-Lead study timelines for regulatory documents and regulatory submission strategy

-Act as a functional area representative and lead on product teams

-Assist with the following activities: hiring resourcing therapeutic areas and project teams and departmental governance

-Ensure quality of regulatory submission documents at all stages of development

-Provide expertise and mentorship on document design and principles of good medical writing to the department and product teams

-Participate in departmental meetings as well as departmental and cross-departmental initiatives

Basic Qualifications:

Doctorate degree

Or

Masters degree and 3 years of Writing Regulatory or scientific submission/documents experience

Or

Bachelors degree and 5 years of Writing Regulatory or scientific submission/documents experience

Or

Associates degree and 10 years of Writing Regulatory or scientific submission/documents experience

Or

High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience

Preferred Qualifications:

-Masters or higher degree in biology chemistry or other scientific field

-5 years in writing clinical and regulatory documents

• Ability to optimally operate in an environment that involves negotiation persuasion collaboration and analytical judgment

• Ability to analyze medical data and interpret its significance

  -Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance eg ICH governing regulatory submission documents and industry compliance

  -Strong written/oral communication skills and attention to detail

  -Understanding and application of principles concepts theories and standards of scientific/technical field

• Strong time and project management skills engaging approach and perseverance with a drive for results

  -Leadership skills and ability to guide and influence the work of others

  -Strong leadership in a collaborative team environment

In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards.

• Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4)

• Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives

• Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications)

• Lead study timelines for regulatory documents and regulatory submission strategy

• Act as a functional area representative and lead on product teams

• Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance

• Ensure quality of regulatory submission documents at all stages of development

• Provide expertise and mentorship on document design and principles of good medical writing to the department and product teams

• Participate in departmental meetings, as well as departmental and cross-departmental initiatives

Additional Skills & Qualifications:

Doctorate degree

Or

Master’s degree and 3 years of Writing Regulatory or scientific submission/documents experience

Or

Bachelor’s degree and 5 years of Writing Regulatory or scientific submission/documents experience

Or

Associate’s degree and 10 years of Writing Regulatory or scientific submission/documents experience

Or

High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience

Preferred Qualifications:

• Masters or higher degree in biology, chemistry, or other scientific field

• 5+ years in writing clinical and regulatory documents

• Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment

• Ability to analyze medical data and interpret its significance

• Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance

• Strong written/oral communication skills and attention to detail

• Understanding and application of principles, concepts, theories, and standards of scientific/technical field

• Strong time and project management skills, engaging approach, and perseverance with a drive for results

• Leadership skills and ability to guide and influence the work of others

• Strong leadership in a collaborative team environment

Experience Level:

Intermediate Level

About Aston Carter:

Aston Carter provides world-class corporate talent solutions to thousands of clients across the globe. Specialized in accounting, finance, human resources, talent acquisition, procurement, supply chain and select administrative professions, we extend the capabilities of industry-leading companies. We draw on our deep recruiting expertise and expansive network to meet the evolving needs of our clients and talent community with agility and excellence. With offices across the U.S., Canada, Asia Pacific and Europe, Aston Carter serves many of the Fortune 500. We are proud to be a ClearlyRated Best of Staffing® double diamond winner for both client and talent service.

Diversity, Equity & Inclusion

At Aston Carter, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email astoncarteraccommodation@astoncarter.com (%20astoncarteraccommodation@astoncarter.com) for other accommodation options.