Medical Writer II (Finance)
Writes and edits various documents to support Clinical Development. Such documents may include clinical study reports (CSRs), common technical document (CTD) summaries for submission to regulatory agencies, protocols, Investigator Brochures, literature reviews, study manuals, and standard operating procedures (SOPs). Assembles CSR and CTD summary appendices and narratives.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Writes and edits CSRs, CTD summaries and other clinical trial documentation as necessary for submission to the Food and Drug Administration (FDA) or other regulatory agencies or for in-company use.
• Assembles CSR and CTD summary appendices and narratives.
• Edits, rewrites, or otherwise prepares drafts of Clinical Protocols and Investigator Brochures.
• Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed.
• Writes and maintains files on informative journal abstracts according to current or estimated future needs.
• Study contact on relevant regular and ad hoc project teams as required.
• Integrates various sources of information into a uniform style and language for regulatory compliance.
• Other duties as needed.
• BS/BA degree in related discipline and five years of related experience; or,
• MS/MA degree in related discipline and three years of related experience; or,
• Equivalent combination of education, experience, and expertise.
• May require certification in assigned area.
• Experience in Biotech/Pharmaceutical industry preferred.
• Prior medical technical writing experience within the biotech/pharmaceutical/CRO realm.
• Experience and significant participation in preparation of clinical documents for regulatory submissions (e.g. clinical protocols, INDs, NDAs, BLAs).
• Familiarity with therapeutic area of Oncology desirable.
• Experience and use of electronic literature tools to obtain reprints of abstracts and medical publications
• Excellent writing ability.
• Proficient in Windows suite.
• Ability to communicate with cross-functional team members (eg, clinical development, biometrics, regulatory affairs, quality assurance, manufacturing, nonclinical) and incorporate diverse feedback into a high-quality document.
• Performs a variety of supervised complicated tasks with creativity and latitude.
• May provide direction to teams based on general policies and management guidance.
• Determines methods and procedures on new assignments.
• Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Has understanding and wide application of relevant technical principles, theories, concepts and techniques.
• Has good general knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
• Networks with key contacts outside own area of expertise.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.