What are the responsibilities and job description for the Clinical Regulatory Writer (Associate Director or Manager) position at myGwork - LGBTQ Business Community?
This job is with AstraZeneca, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly. Job Title: Clinical Regulatory Writer, Associate Director or Manager
Location: Boston, MA - Hybrid (3 days onsite)
Introduction To Role
Are you ready to be part of the solution, turning drug development strategies into reality? As a Clinical Regulatory Writer, you will play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca's core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals.
Accountabilities
As a Clinical Regulatory Writer, you will:
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.
Essential Skills/Experience
Education/Experience required:
Associate Director level : BS Life Sciences degree or simiilar, 7 yrs medical writing experience in pharmaceutical industry or CRO.
Manager level: BS Life Sciences degree or simiilar, 2-7 yrs medical writing experience in 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 Skills/Experience
Advanced degree in a scientific discipline (Ph.D.)
Experience with CSR, CTD module 2 summaries
Experience leading clinical submission (NDA/BLA/MAA)
Experience developing clinical submission communication strategy
This is a Hybrid role - minimum requirment 3 days per week onsite
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
AstraZeneca is where innovation meets collaboration. We harness diverse knowledge to move with agility, working seamlessly across functions globally. Our team is empowered to make quick decisions, influencing drug development strategy at all levels. With a science-driven approach, we bring life-changing medicines to patients, constantly asking questions and trying new things. Your professional growth is passionately supported here, with opportunities to work on projects at all stages of development.
Ready to make an impact? Apply now and be part of our dynamic team!
The annual base pay (or hourly rate of compensation) for this position ranges from $133,042.40 - $199,563.60 USD Annual for Associate Director level, and $ 113,293.60 - $169,940.40 USD Annual for Manager level. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Salary: Negotiable
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Location: Boston, MA - Hybrid (3 days onsite)
Introduction To Role
Are you ready to be part of the solution, turning drug development strategies into reality? As a Clinical Regulatory Writer, you will play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca's core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals.
Accountabilities
As a Clinical Regulatory Writer, you will:
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.
Essential Skills/Experience
Education/Experience required:
Associate Director level : BS Life Sciences degree or simiilar, 7 yrs medical writing experience in pharmaceutical industry or CRO.
Manager level: BS Life Sciences degree or simiilar, 2-7 yrs medical writing experience in 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 Skills/Experience
Advanced degree in a scientific discipline (Ph.D.)
Experience with CSR, CTD module 2 summaries
Experience leading clinical submission (NDA/BLA/MAA)
Experience developing clinical submission communication strategy
This is a Hybrid role - minimum requirment 3 days per week onsite
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
AstraZeneca is where innovation meets collaboration. We harness diverse knowledge to move with agility, working seamlessly across functions globally. Our team is empowered to make quick decisions, influencing drug development strategy at all levels. With a science-driven approach, we bring life-changing medicines to patients, constantly asking questions and trying new things. Your professional growth is passionately supported here, with opportunities to work on projects at all stages of development.
Ready to make an impact? Apply now and be part of our dynamic team!
The annual base pay (or hourly rate of compensation) for this position ranges from $133,042.40 - $199,563.60 USD Annual for Associate Director level, and $ 113,293.60 - $169,940.40 USD Annual for Manager level. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Salary: Negotiable
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Salary : $133,042 - $199,564