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Associate Director Medical Writing

Job Description

Director AND Associate Director Medical Writer - Oncology


Immediate Director AND Associate Director Medical Writer Need with a pharmaceutical company in New Providence, NJ.


They have a strong focus on Oncology with a robust pipeline for treatment of hematological cancers and solid tumors.


This a 6 month contract to HIRE!!!


Job Responsibilities:

  • Work with the clinical and regulatory teams to independently prepare and lead the planning and development of clinical and regulatory documents across clinical programs, including but not limited to Clinical Study Reports (CSRs), protocols, protocol amendments, Briefing Packages, DSURs, Investigator Brochures {IBs), IND and BLA clinical sections in eCTD format under strict timelines. Work closely with study teams to ensure that documents are scientifically accurate, internally consistent, and meet intended purpose. Act as a subject matter expert on internal standards and external regulatory guidelines.
  • Ensures key messages are clear and consistent within and across documents. Contribute strategically and scientifically at the project and/or study team level
  • Understand clinical data and use text, tables, and figures as appropriate to accurately and effectively convey key messages;
  • Oversee all internal and outsourced medical writing activities for scientific content and alignment with company position, clarity, accuracy, and consistency;
  • Lead and collaborate with cross-functional team members (Clinical Operations, Clinical Development, PK, Biometrics, Pharmacovigilance, Regulatory affairs, Quality, and CMC) to develop strategy and timelines to ensure accurate and timely completion/delivery of high-quality, scientifically-justified documents.
  • Gives input to process improvement within and across functional areas
  • Implements document quality controls, standards and best practices Process and Resource Management, assist with quality control (QC) and 'peer' review of clinical study reports and other submissions.
  • Assist in the day-to-day operational activities and other assignments as needed and specified by management.

Requirements:

  • Advanced degree preferred (PhD or PharmD) with 6-8 years of experience writing regulatory documents in pharmaceutical industry OR Master's degree in a scientific discipline with 10+ years of experience in a pharmaceutical, biotechnology, contract research company {CRO)
  • Prior experience in Oncology//hematology therapeutic area is desired.
  • Direct recent experience with submissions to the US FDA (NDA, BLA) and EMA (MAA)
  • Current experience with eCTD requirements
  • Experience in the preparation of protocols, study reports, investigator brochures, safety updates, and BLA/IND/NDA clinical sections

Perks:

  • Work from Home: Mondays and Fridays (after the 1st month)

Please reach out to discuss the details as we are looking to schedule phone screens March 19th!




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards 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 call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 

Job Snapshot

Location US-NJ-New Providence
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Pharmaceutical
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Company Overview

Aerotek

We know that a company’s success starts with its employees. We also know that an individual’s success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek’s people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With more than 230 non-franchised offices, Aerotek’s 6,000 internal employees serve more than 300,000 contract employees and 17,000 clients every year. To learn more, visit Aerotek.com. Learn More

Contact Information

US-NJ-New Providence
Lauren Houmis
9738294437
Snapshot
Aerotek
Company:
US-NJ-New Providence
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Pharmaceutical
Store Type:

Job Description

Director AND Associate Director Medical Writer - Oncology


Immediate Director AND Associate Director Medical Writer Need with a pharmaceutical company in New Providence, NJ.


They have a strong focus on Oncology with a robust pipeline for treatment of hematological cancers and solid tumors.


This a 6 month contract to HIRE!!!


Job Responsibilities:

  • Work with the clinical and regulatory teams to independently prepare and lead the planning and development of clinical and regulatory documents across clinical programs, including but not limited to Clinical Study Reports (CSRs), protocols, protocol amendments, Briefing Packages, DSURs, Investigator Brochures {IBs), IND and BLA clinical sections in eCTD format under strict timelines. Work closely with study teams to ensure that documents are scientifically accurate, internally consistent, and meet intended purpose. Act as a subject matter expert on internal standards and external regulatory guidelines.
  • Ensures key messages are clear and consistent within and across documents. Contribute strategically and scientifically at the project and/or study team level
  • Understand clinical data and use text, tables, and figures as appropriate to accurately and effectively convey key messages;
  • Oversee all internal and outsourced medical writing activities for scientific content and alignment with company position, clarity, accuracy, and consistency;
  • Lead and collaborate with cross-functional team members (Clinical Operations, Clinical Development, PK, Biometrics, Pharmacovigilance, Regulatory affairs, Quality, and CMC) to develop strategy and timelines to ensure accurate and timely completion/delivery of high-quality, scientifically-justified documents.
  • Gives input to process improvement within and across functional areas
  • Implements document quality controls, standards and best practices Process and Resource Management, assist with quality control (QC) and 'peer' review of clinical study reports and other submissions.
  • Assist in the day-to-day operational activities and other assignments as needed and specified by management.

Requirements:

  • Advanced degree preferred (PhD or PharmD) with 6-8 years of experience writing regulatory documents in pharmaceutical industry OR Master's degree in a scientific discipline with 10+ years of experience in a pharmaceutical, biotechnology, contract research company {CRO)
  • Prior experience in Oncology//hematology therapeutic area is desired.
  • Direct recent experience with submissions to the US FDA (NDA, BLA) and EMA (MAA)
  • Current experience with eCTD requirements
  • Experience in the preparation of protocols, study reports, investigator brochures, safety updates, and BLA/IND/NDA clinical sections

Perks:

  • Work from Home: Mondays and Fridays (after the 1st month)

Please reach out to discuss the details as we are looking to schedule phone screens March 19th!




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards 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 call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 
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Associate Director Medical Writing Apply now