Principal Medical Writer
Principal Medical Writer 1275190
Job Scope & Purpose:
Our Boston based client is looking for an experienced regulatory medical writer to join their growing team. The incumbent will support the development of oncology drug candidates by providing medical writing expertise and support to cross-functional project teams. Applicants should have previous experience authoring clinical, regulatory and pharmacovigilance documents such as clinical study protocols and amendments, study reports, investigator’s brochures, safety reports, briefing packages, and clinical summary documents. If you have previous experience working for an oncology focused medical writing team with a biotech or pharmaceutical company and are looking for a new challenge where you can work globally to impact cancer development, continue reading and consider applying today.
Primary Job Requirements:
- BS required, advanced degree in scientific discipline preferred
- At least 5 years in medical writing with experience in oncology preferred, including participating in submissions to the US FDA (NDA, BLA) and EMA (MAA)
- Experienced in the preparation of clinical and regulatory, documents
- Understand regulatory requirements for different phases of development and different regulatory pathways
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.
Code: RegQA
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.