Takeda Pharmaceuticals
Associate Director, Medical Writing - Remote
Takeda Pharmaceuticals, Providence, Rhode Island, us, 02912
Takeda Pharmaceuticals Associate Director, Medical Writing - Remote Providence, Rhode Island Apply Now
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. Join Takeda as an Associate Director Medical Writing where you will be responsible for medical writing activities for a program or multiple programs within a therapeutic area depending on the scope and stage of clinical development. With minimal oversight, you will provide strategic direction to cross-functional project teams to ensure that clinical regulatory documents (e.g., investigators' brochures, study protocol and amendments, study reports) accurately present key clinical messages in accordance with program goals and regulatory requirements.How you will contribute:Lead the writing strategy providing expertise including organization, content, timelines, and resource requirements.Provide advanced input for study designs, analysis plans, sections of INDs, and marketing applications.Coordinate activities of Takeda employees, contract employees, and vendors, ensuring resolution of issues.Manage deliverables and preparation of documents for submission to FDA or other regulatory agencies.Represent Medical Writing on cross-functional teams and task forces.Serve as lead writer for important regulatory response documents and key components of regulatory submissions.The Associate Director, Medical Writing is seen as an expert in medical writing and performs work independently with minimal supervision.Minimum Requirements/Qualifications:Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor’s degree is required.At least 10 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company.Experience as lead writer for key documents included in major US and/or international regulatory submissions.Demonstrated ability to understand and interpret clinical and scientific data with minimal oversight.Excellent project management skills including understanding of clinical timelines and roles of other functional areas.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work.This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.#LI-RM1
If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information.#J-18808-LjbffrRemote working/work at home options are available for this role.
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. Join Takeda as an Associate Director Medical Writing where you will be responsible for medical writing activities for a program or multiple programs within a therapeutic area depending on the scope and stage of clinical development. With minimal oversight, you will provide strategic direction to cross-functional project teams to ensure that clinical regulatory documents (e.g., investigators' brochures, study protocol and amendments, study reports) accurately present key clinical messages in accordance with program goals and regulatory requirements.How you will contribute:Lead the writing strategy providing expertise including organization, content, timelines, and resource requirements.Provide advanced input for study designs, analysis plans, sections of INDs, and marketing applications.Coordinate activities of Takeda employees, contract employees, and vendors, ensuring resolution of issues.Manage deliverables and preparation of documents for submission to FDA or other regulatory agencies.Represent Medical Writing on cross-functional teams and task forces.Serve as lead writer for important regulatory response documents and key components of regulatory submissions.The Associate Director, Medical Writing is seen as an expert in medical writing and performs work independently with minimal supervision.Minimum Requirements/Qualifications:Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor’s degree is required.At least 10 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company.Experience as lead writer for key documents included in major US and/or international regulatory submissions.Demonstrated ability to understand and interpret clinical and scientific data with minimal oversight.Excellent project management skills including understanding of clinical timelines and roles of other functional areas.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work.This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.#LI-RM1
If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information.#J-18808-LjbffrRemote working/work at home options are available for this role.