Sr. Medical Writer

BioCryst

Posted on: June 20, 2022

Closing: July 20, 2022

Salary: Undisclosed

Position Type: Full Time

Job Description

At BioCryst, we are passionate about advancing novel therapeutics for patients with rare and serious diseases. Our structure-guided drug design process leads us to the discovery and development of novel small-molecule drugs. We integrate traditional biology and medicinal chemistry along with a wide array of advanced technologies to understand the three-dimensional structures of active sites of target enzymes. Our scientists then design molecular structures to create bespoke drugs for patients. We focus on therapeutic areas with either no available treatments or large unmet patient needs. BioCryst’s US headquarters are located in Durham, North Carolina, our European headquarters in Dublin, Ireland and our Discovery Center of Excellence in Birmingham, Alabama. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit the Company’s website at www.biocryst.com.

JOB SUMMARY:

The purpose of this role is to write or coordinate the preparation of, all clinical, regulatory, and scientific documents intended to support clinical and regulatory deliverables for BioCryst drug development project teams. The scope of the role includes authoring, review, managing document timelines and workflow, and quality assurance check of documents and management of external medical writers. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Author or coordinate the authoring of clinical documents including study investigators brochures, clinical study reports, and clinical study summaries (for posting to study registries).
• Author or coordinate the authoring of regulatory documents including Common Technical Document (CTD), clinical and nonclinical sections for IND, NDA, and MAA documents, briefing documents for regulatory interactions (FDA meetings, EMA Scientific Advice), and responses to regulatory agency questions.
• Author or coordinate the authoring of multidisciplinary documents including orphan drug designation requests, manuscripts, and posters.
• Support primary author, writing or coordinating first drafts, managing internal and external reviews, and journal submission.
• Organizes Framework Meetings prior to the initiation of key clinical or regulatory documents to ensure alignment on essential insights and scope.
• Coordinate the review and quality check of all documents.
• Work with Clinical Development, Biostatistics, Safety, Regulatory Affairs, and Project Management to ensure document preparation timelines are consistent with Program goals.
• All other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Bachelor's and advanced degree, a life science-related discipline preferred.
• 8-10+ years’ experience (or an equivalent combination of education and experience) in Medical Writing in the Biopharmaceutical industry, with regulatory writing experience supporting IND and NDA filings.
• Ability to work without close supervision.
• Excellent written, verbal, and interpersonal communication skills.
• Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
• Ability to multi-task and complete assignments on time.
• Excellent problem-solving capabilities and organizational skills.
• Knowledge of medical, pharmaceutical, and clinical research concepts.
• A high degree of familiarity with statistical and data output.
• Expert level skills in relevant computer software including Microsoft Word and familiarity with bibliographic citation tools and software.
• Knowledge of the methods, techniques, and procedures of medical writing tasks.
• Prior clinical protocol and CSR writing experience.
• Prior experience with documents for submissions in electronic Common Technical Document (eCTD) format.
• Detailed and experienced-based understanding of applicable regulations and the CTD structure.

 

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

BioCryst requires all U.S. based employees to either (a) establish that they have been fully vaccinated against COVID-19; or (b) obtain an approved exemption as an accommodation. Proof of vaccination or an approved exemption form is required after a conditional job offer has been made to the applicant and prior to the start date. This requirement is a condition of employment at BioCryst, and it applies regardless of whether the position is located at a physical BioCryst location or is fully remote.

BioCryst

Posted on: June 20, 2022

Closing: July 20, 2022

Salary($): Undisclosed

Position Type: Full Time

Career Focus: Medical Writing

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