Regulatory Medical Writer (Remote)

Key Responsibilities

• Creates writing deliverables that include, but may not be limited to:

o clinical study protocols and clinical protocol amendments;

o clinical study reports;

o IND submissions and annual reports;

o Integrated summary reports;

o NDA and (e)CTD submissions;

o investigator brochures, as well as;

o clinical journal manuscripts, clinical journal abstracts, and client

presentations.

• Reviews statistical analysis plans and table/figure/listing specifications for

appropriate content, and for grammar, format, and consistency.

• Interacts with department head and staff members in data management,

biostatistics, regulatory affairs, and medical affairs as necessary to produce writing

deliverables.

• Adheres to established regulatory standards, including but not limited to ICH-E3

guidelines, as well as Company Standard Operating Procedures, client standards,

and Company and/or client approved templates when completing medical writing

projects, on-time and on-budget.

• Coordinate quality control reviews of documents and maintaining audit trails of

changes.

• May perform quality control (QC) review if requested by supervisor (e.g., QC in-text

tables against statistical tables, verify titles in standard table of contents, paginate a

document, etc.).

• Provide input on data analysis planning and interpretation.

• Assist with project-related administrative tasks (e.g., copying of data and insertion

into tabbed binders, replacing old data with new data, etc.).

• Demonstrates knowledge of regulatory submission requirements and processes.

Education and Experience

• Bachelor’s degree in the life sciences; MS or PhD preferred.

• Minimum of 2 years of experience in the writing regulatory documents for

pharmaceutical, biologic or medical device companies.

• Expert word processing skills in MS Word, including proficiency with tables, graphs,

and figures are required.

• Must be able to work in a collaborative team environment.

• Strong computer skills, project management skills, and a high attention to detail.

• Excellent demonstrable understanding of ICMJE and GPP guidelines and

regulations required.

• Ability to write presentations and articles for peer reviewed publications that conform

to prescribed style and format.

• Knowledge of internet software, spreadsheet software, word processing software,

graphics software (e.g., PowerPoint), bibliographic software e.g. EndNote) and any

other applicable software as may be needed by the job from time to time as it

changes.

Preferred Skills

• Proven team player who can focus and continuously reinforce efforts to meet

timelines.

*CO candidates may not be considered

***Compensation within this range will be commensurate with level of experience***