Senior Medical Writer

Needham, MA

Senior Medical Writer 2028496
LocationMA, NY, NJ, DE, CT, CA, PA based (Remote) 
Therapeutic Areas:  Undisclosed
Job Overview: The Senior Medical Writer will provide hands-on medical writing expertise, review data, and collaborate with internal teams across preclinical and clinical stage projects.
Primary Job Responsibilities:

  • Develop and manage clinical documents, ensuring accuracy, consistency, and regulatory compliance
  • Adhere to timelines, ensuring efficient completion of writing assignments
  • Summarize data clearly, maintaining document consistency and standardization
  • Serve as a medical writing expert, leading discussions and addressing audit findings effectively
Primary Job Requirements:
  • Advanced scientific degree and a minimum of 4 years in pharmaceutical regulatory writing
  • Understand drug development, clinical data, and cross-departmental relationships
  • Be knowledgeable of ICH-GCP and regulatory requirements, with experience in IND/NDA submissions
  • Possess excellent communication, organizational skills, and proficiency in MS Office and publishing software


About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

 

 

 

 

 

 

 

 

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.

Employee Type:
FullTime

Location:
Needham, MA

Job Type:
Strata: Clin/Reg

Date Posted:
May 8, 2024

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