Proclinical is currently recruiting for a REMOTE Medical Writer with a biopharmaceutical company.
- Responsible for providing clinical regulatory document support to the clinical teams, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the clinical writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups (e.g., PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of clinical regulatory submissions.
- Serves as medical writing lead on clinical regulatory documents. Works closely with the Regulatory team(s) on document strategies. Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US).
- Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained.
- Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with clinical regulatory requirements.
- Effectively communicates clinical regulatory document deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates and with an appropriate quality level. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate.
- Interprets and explains data generated from a variety of sources. Verifies that results are consistent with protocols. Challenges conclusions when necessary. Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies.
- Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs.
- Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. eDocs and eCTD databases). May mentor and provide guidance to more junior medical writers and/or external vendor/agencies. Implements tactical process improvements.
Skills and Requirements:
- Bachelor of Science; in related field
- At least 5 years of medical writing experience in the pharmaceutical, health care, or regulated industry experience
- Writing clinical summary of safety and clinical summary of efficacy a plus.
- Experience in experimental design and clinical/preclinical data interpretation preferred.
- Knowledgeable of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions.
- Ability to assimilate and interpret scientific content and translate information for appropriate audience.
- 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.
- Experienced in writing Phase 2-4 clinical study reports.
- Demonstrated ability in leading cross-functional teams
- Demonstrated ability to manage timelines and execute to due date.
- Excellent organizational skills, attention to detail, and strong oral and written communications skills
If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.