Associate Director, Medical Writing (Regulatory)

The Associate Director, Medical Writing (Regulatory) will collaborate with colleagues to write high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements.

Responsibilities:

Author, co-author, critically edit, and format clinical/regulatory documents, including New Drug Applications (NDAs), protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, administrative letters, and other regulatory submissions as needed

Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Project Management, CMC, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents

Develop and manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs

Facilitate comment resolution and adjudication with authors, reviewers, and project teams

Oversee vendors and contractors

May include management of in-house medical writing staff (based on experience and team need)

May serve as the functional area representative on project teams and advise such teams on content, format, and style requirements for documents

Participate in the development/refinement of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control to ensure efficient preparation of high-quality medical writing deliverables

Assist in the interviewing, mentoring, and integration of medical writing staff as needed

Maintain subject area expertise related to the company’s investigational products, disease indications, and regulatory and publication guidelines

Perform miscellaneous job-related duties and additional duties and responsibilities as needed

Preferred Skills, Qualifications and Technical Proficiencies:

Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines

Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness

Successful track record of working on complex clinical/regulatory writing projects across multiple therapeutic areas

Excellent attention to detail, multitasking, prioritization, and flexibility

Excellent communication skills with proven ability to interact in a cross-functional environment

Understanding of the drug-development process, including research and development processes and objectives and the required documents

Familiarity with US and European regulatory requirements and guidelines for documents; general knowledge of electronic Common Technical Document (e-CTD) requirements with respect to structure, format, and content

Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas

Proficiency in use of MS Office applications (Word, Outlook, Excel, PowerpointPowerPoint), Adobe Acrobat, electronic document management systems (eg, Veeva Vault, Box, SharePoint), and templates (eg, StartingPoint).

Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities

Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervision

Ability to think strategically, be resourceful, and lead without formal authority

Preferred Education and Experience:

BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred

8+ years of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience writing clinical study protocols, clinical study reports, investigator’s brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs); and understanding of the content of higher-level summary documents

Knowledge of endocrinology, oncology, neurology and/or metabolic disease areas preferred

The pay range that the Company reasonably expects to pay for this headquarters-based position is $181,000 - $213,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.

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