Now Hiring -Principal Medical Writer

We are a diverse and highly passionate team of professionals focused on one goal: getting life-changing and lasting therapies into the patients who need them most. We are looking for a Principal Medical Writer dedicated to Public Health, passionate about gene therapy development, and committed to making a difference in the lives of millions of patients, who can’t wait.

The Principal Medical Writer is responsible for providing scientific publications, presentations, or regulatory document support and advanced scientific writing expertise to the clinical teams, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the writing process. Provides medical writing expertise for multiple compounds and/or projects within Nanoscope’s therapeutic area. Interfaces with team members and external (e.g. PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing, Key Opinion Leaders, Medical Affairs) to ensure accurate and timely completion/delivery of information and review of scientific publications or clinical regulatory submissions. Serves as the scientific writing content expert.

We strongly encourage professionals with experience in ocular indications, rare diseases, or gene therapy to apply.

Internal Interfaces:

• Reports to: Chief Medical Officer
• Coordinates with: Chief Scientific Officer, Chief Medical Officer, Chief Technology and Manufacturing Officers, SVP-Regulatory and Quality, VP-Clinical Development, VP-Clinical Operations Officer, Lead-Medical Affairs, Biostatistics / Data Management, Project Management

External Interfaces:

• Key Opinion Leaders, SME-Consultants, Scientific Journals and Trade Media, Conference Coordinators, Patient Advocacy Groups, Regulatory Bodies; Vendors/Suppliers, Contract Research Organizations

Key Responsibilities:

• Serves as medical writing lead on more complex scientific publications or clinical regulatory documents such as those associated with filings and dossiers. Works closely with the Publications or Regulatory team(s) on document strategies.
• Implements all activities related to the preparation of scientific publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical data reports.
• Serves as a subject matter expert for Nanoscope’s therapeutic/product areas. As assigned, provides medical writing direction and guidance to assigned projects, including review of work product. Provides input and feedback to management regarding medical writing work product/quality.
• Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained.
• Responsible for effective communication among team members. Communicates deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Must identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals.
• Understands, assimilates, and interprets sources of info with appropriate guidance/direction from product teams and/or authors. Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols. Confirms completeness of info to be presented. Challenges conclusions as necessary. Independently resolves document content issues and questions.
• Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs.
• Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to scientific publications or clinical regulatory documents.
• Works with Regulatory Quality Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate), and works with team to draft responses as necessary.
• Maintains expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Advises teams regarding compliance with scientific publications or clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively. Learns and applies knowledge of therapeutic area and product to scientific publishing projects. Must continually train/be compliant with current standards.
• Serves as a medical writing representative on project teams. Acts as Subject Matter Expert regarding computer-based technologies utilized by the respective departments (e.g. eDocs, eCTD, journal/ congress databases). Assists and provides guidance to external medical writers and vendors/agencies. Recommends, leads, and implements tactical process improvements.

Qualifications

• Bachelor of Science required, with significant relevant writing experience, or Bachelor’s degree in English or communications, with significant relevant science experience. Masters or PhD in science discipline preferred with relevant writing experience.
• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
• 4 years relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D.
• 2 years ophthalmology gene therapy industry experience preferred.
• 4 years experience in experimental design and clinical/preclinical data interpretation preferred.
• High-level content writing experience and experience with all types of clinical publications or clinical regulatory documents required. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience. Working knowledge of statistical concepts and techniques.
• Expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.
• Knowledge and expertise with Common Technical Document content templates. Expert knowledge of current electronic document management systems and information technology.
• Excellent written and oral communication skills. Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
• Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment.
• Extensive experience in working with collaborative and cross-functional teams, both intra-organizationally and extra-organizationally in-person, through MS Teams/Skype/Zoom/ WebEx sessions; had project management experience, bringing working teams together for common objectives.
• Willingness to travel to various meetings, including overnight trips and up to 25% domestic/international travel may be required in the future.