Associate Director, Medical Writing
Associate Director, Medical Writing 1317461
Location: Watertown, MA (Remote)
Science/ Focus: Small Molecule
Therapeutic Area(s): Viral infections and liver diseases
Job Overview: This individual will lead medical writing activities for clinical documentation preparation to support the advancement of clinical-stage programs.
Responsibilities:
- Coordinate the preparation and timely delivery of high-quality documents for domestic and international regulatory filing and clinical programs
- Produce documents to support clinical trials and regulatory submissions, in accordance with domestic and international regulations and guidelines
- Prepare detailed timelines of writing activities for assigned documents and validate dates with all impacted document production team members
- 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 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.
Qualifications:
- MS or PhD (preferred)
- 5+ years Medical Writing experience in the biopharmaceutical industry
- 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
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.
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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.