Medical Writer

Cambridge, MA

Medical Writer 1116559

Job Scope & Purpose:

Our client, a small, oncology-focused biotech company in Cambridge is seeking a medical writer experienced in regulatory submissions to join their growing team. Applicants should have a working knowledge of regulatory medical writing requirements with previous experience planning, preparing, writing, editing, formatting and finalizing high quality non-clinical, clinical, and regulatory documents, including clinical study protocols and amendments, clinical study reports, Investigator’s Brochures, aggregate safety reports, etc. If you have previous experience writing for a biotech/pharmaceutical company as a regulatory writer, continue reading and consider applying today.

Primary Job Requirements:

  • Bachelor’s degree in health sciences or related field with 2-4 years of medical writing experience in a pharmaceutical/biotechnology or CRO environment, or equivalent combination of education and experience. Advanced degree preferred
  • Familiarity with the requirements for preparation of key clinical and regulatory documents
  • Working knowledge of ICH and US regulatory requirements is required; working knowledge of other ex-US regulatory requirements is desired.
  • Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
  • Ability to interpret and present clinical data objectively in a clear, concise format; ability to help SMEs present specialty (e.g., non-clinical, PK, etc.) information clearly and concisely.

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.

achan@stratacuity.com
Code: ClinOps

 

 

 

 

 

 

 

 

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@apexsystemsinc.com or 844-463-6178.