In collaboration with key contributors, writes and edits assigned regulatory documents that conform to global regulatory submission and internal document standards.

May collaborate with other writers or manage the writing effort of contract writer(s) to complete deliverables.

Provides peer review, quality control, and editing support for regulatory documents and may also provide editorial or review support for other types of documents, such as manuscripts or presentations, CRFs, or study materials.

Develops and maintains document templates and content guidelines that conform to document specifications and internal publishing requirements for regulatory filing.

Develops and maintains work process documents, Style Guide, or other instruments relevant to development of regulatory documents.

Assists in the preparation and distribution of documentation to the project team members.

Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.

Works effectively with cross-functional groups within BioMetrics and document production teams.

During project development, serves as clinical subteam specialist in clinical documentation.

Ensures content and messages are consistent across regulatory documents within a project.

Performs regulatory intelligence for information pertinent to Medical Writing and provide preliminary assessment of impact of new or modified regulations and guidances.

Mentors writers.

Other tasks as assigned.

Education

Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing.

Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

Experience

Fulfills one of the following:

5 to 8 years of experience as a medical writer in the pharmaceutical industry

At least 8 years of experience in the pharmaceutical industry

At least 10 years of medical or scientific writing experience as a fulltime and primary job responsibility

Clinical Studies

Intermediate understanding of the drug development process (discovery to market), clinical study conduct, and clinical study data collection and basic understanding of database management, data integration, and generation of datasets.

Intermediate applied knowledge of documentation required for the conduct of clinical studies, protocol design (including objectives, efficacy and safety endpoints procedures for collecting and reporting AEs and SAEs), and study results reporting.

Direct experience with documentation for at least 3 phases of drug development.

Medical Writing

Advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.

Advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.

Skilled in data interpretation from complex tabular and graphical clinical data presentations; able to draw conclusions and to enhance the interpretation based on related output.

Ability to create complex tables as required.

Intermediate to advanced applied knowledge of basic clinical laboratory tests.

Advanced capabilities to research literature and interview subject matter experts to quickly gain familiarity with therapeutic area

Advanced understanding of the concepts of coding dictionaries (MedDRA, WHO Drug)

Intermediate understanding of biostatistical and clinical research concepts.

Intermediate understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection.

Fully capable of writing high-quality documents that support corporate goals and objectives.

Able to mentor others in all of the above skills and tasks.

Computer/Office Equipment Skills