Associate Director, Medical Writing 1263100\ \ \ \ Job Scope & Purpose:\ \ \ \ Our client is seeking an experienced Medical Writer to join their team! The research and development activities use a robust, chemistry-driven approach in the development of small molecule drugs for the treatment of viral infections, liver diseases and COVID19. The Medical Writer will lead medical writing activities for clinical documentation preparation to support the advancement of clinical-stage programs. This person will report to the VP, Regulatory Affairs and be responsible for managing external writers.This opportunity has the flexibility to be remote if you live within a commuting distance to Watertown, MA.\ \ \ \ Primary Job Responsibilities:\ \ \ \ \ \ \ Coordinate the preparation and delivery of high-quality documents for domestic and international regulatory filing and clinical programs.\ \ \ Produce documents to support clinical trials and regulatory submissions\ \ \ Prepare detailed timelines of writing activities for assigned documents\ \ \ Research and recommend external partners, and monitor the quality and progress of subcontracted writing activities\ \ \ Lead the development of clinical protocols and amendments, investigator's brochures (IBs), clinical study reports (CSRs), investigational new drug (IND) applications and clinical documents to support Health Authority submissions\ \ \ Lead the development of standard operating procedures for improved efficiencies in clinical document production, editorial style guides, clinical document templates, clinical document publishing, and implementation of content management systems to ensure consistent and high-quality clinical documents.\ \ \ \ \ \ Primary Job Requirments:\ \ \ \ \ \ \ MS or PhD in a relevant scientific field is strongly preferred\ \ \ 5+ years Medical Writing experience in the biopharmaceutical industry\ \ \ In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.\ \ \ Prior experience with IND/CTA/NDA/BLA/MAA submissions and expertise in requirements, including eCTD standards\ \ \ Knowledge of clinical trial transparency requirements; familiarity with submissions to clinical trial registries (ClinicalTrials.gov, EudraCT)\ \ \ \ \ \ 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: 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 or .