This Medical Writer is expected to be able to advise and collaborate on document strategy, authoring and review processes, and should establish best practices to generate high quality clinical and regulatory submission documents in compliance with ICH/GCP/regulatory guidelines. This position reports to the Chief Medical Officer.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Write, edit, contribute to, and manage the development of a variety of clinical and regulatory documents, as well as other documents per business needs.
Assess medical writing needs and ensure that each is adequately resourced for timely completion (in house and/or by consultant/CRO support).
Prepare scientific and regulatory documents for submission to the Food and Drug Administration (FDA) (Investigational New Drug applications, biologic license applications, annual reports, preclinical and clinical study reports, safety reports, and investigator’s brochures)
Ensure smooth and effective document management from start to finish (i.e., from template to final approved version), including but not limited to first draft authoring, coordination of review and adjudication, generation of bibliographies, and adherence to the style guide.
Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives, as required, ensuring adherence to applicable standards and requirements.
Support the development, implementation, and improvement of best practices, the document process, and SOPs as needed.
Develop and maintain templates and outlines for key documents.
Performs literature searches and/or prepares summaries of results
Prepares meeting reports and proceedings, safety documents or data analysis
Contributes to technical proposals and responds to technical questions
Full COVID-19 vaccination required; APT employees are required to be fully vaccinated against COVID-19 to work on the premises.
5-8 years of experience in medical or scientific writing in the pharmaceutical or biotech industry.
PhD/PharmD in a medically relevant scientific discipline, or a master's degree with 4 years of relevant work experience.
Previous experience with regulatory document authoring.
Track record of developing high-quality clinical development and scientific documents with experience writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, BLA/NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
In depth knowledge of drug and biologic development and approval processes and GCP principles.
Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support.
Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables.
Ability to manage/prioritize multiple projects and work in a fast-paced environment.
Flexible and able to adapt to changing deadlines and priorities.
Strong written, verbal, and interpersonal communication skills.
Highly attentive to detail.
Self-motivated and able to self-manage effort to maintain alignment with corporate goals.
Proficiency in the use of Microsoft Office applications and experience working in electronic document management systems.
Experience in responding to company and regulatory audits is a plus.
Please note this job description is not an all-encompassing and comprehensive list of activities, duties, or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
***APT is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. APT seeks to diversify its work force and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. At APT, we don’t just accept difference we celebrate it, we support it, and we thrive on it for the benefit of our employees, our therapeutics, and our community.