Principal/Senior Medical Writer 1153867
Job Scope & Purpose:
Our long-term client is a clinical stage biopharmaceutical company focused on acute kidney injury and seeking a Principal Medical Writer to join an impressive team. The company offers a robust pipeline and room to grow. The principal medical writer will serve as subject matter expert on clinical protocols, protocol amendments, clinical study reports, Investigator’s Brochures, and briefing books. The principal medical writer may also provide guidance on document strategy for more complex dossiers for regulatory submission such as IND and NDA/BLA filings. The position requires the ability to work collaboratively with cross-functional teams in a fast-paced environment. Other qualifications include the ability to recognize and resolve resourcing or scheduling conflicts across projects and communicate with upper management. The qualified candidate will also have experience in management of external vendors and the development of operational process improvements such as work practice documents, SOP development and updates, and document templates.
Primary Job Responsibilities:
Primary Job Requirements:
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.
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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 firstname.lastname@example.org or 844-463-6178.