Senior Medical Writer

Company: Kinsley Power Systems
Location: Waltham
Posted on: September 13, 2020

Job Description:

Independently writes clinical protocols, reports, and investigator brochures and mentors junior writers. The Sr. Medical Writer will collaborate with other writers, other departments, and medical writing vendors to ensure quality and consistency of clinical documents submitted to regulatory agencies.

Key Responsibilities

Collaborates with Biostatistics, Clinical Operations, Clinical Science, Translational Medicine, Regulatory Affairs, and other departments on the development and/or revision of protocols, protocol amendments, clinical study reports, clinical sections of regulatory submission documents, investigator’s brochures, presentation material, etc. Writes CTD Module 2 summary documents and Module 5 integrated summaries

Manages all aspects of the medical writing processes for document development including quality control, scheduling/timeline management, driving document preparation, coordinating document reviews and revisions, maintaining version control, and coordinating final reviews and approval

Researches and collects source documentation (eg, literature searches, project files). Helps maintain database of literature references

Participates in reviewing, editing, and creating SOPs, job aids, and templates. Acts as recognized technical resource for peers. Improves operational procedures for the Medical Writing group and implements them

Attends regular project meetings, identifies project tasks, and with the Sr. Director of Medical Writing, formulates strategy for completion. Plays an educational role on cross-functional project teams, advocating for better understanding and appreciation of Medical Writing’s place in clinical development

Acts as an internal and external liaison for Medical Writing. Plays an active role in negotiating timelines for primary projects. Provides guidance and expertise to work teams regarding all aspects of clinical writing, including the correct usage of templates as well as the content of regulatory guidances on documents

Routinely contributes to the training and development of less-experienced peers. Coaches less-experienced team members in problem solving. Provides constructive input for performance evaluations

Supervises and reviews the work of more junior medical writers, as well as contract medical writers

Minimum Education & Experience Requirements

BS in medical or life sciences or related area, plus a minimum of 3 years of writing experience in a clinical development or other scientific environment, OR

M.Sc./MPH, and 2 years of experience as a medical writer OR

Ph.D. in life sciences, and 18 months of experience as a medical writer

Knowledge/Skills/Attributes Needed

Good understanding of experimental design and ethical principles in human clinical trials

Proficiency in clinical writing, including protocols, study reports, and investigator brochures. Familiarity with the writing of CTD summary documents. Good understanding of clinical research documentation, ICH guidelines, and GCP.

Must be very skilled in written and oral communication. Intermediate-to-advanced negotiation skills required, to allow effective collaboration with other disciplines on complex projects. Exemplary proficiency in presentation skills needed.

Good understanding of the work of other clinical functional areas. Sufficient understanding of biostatistics to correctly interpret and describe results in clinical reports and other documents.

Demonstrated proficiency in Microsoft Office software and advanced proficiency in MS Word. Skilled in using and developing document templates. Proficiency using EndNote software.

Capacity to provide thoughtful coaching of junior writers

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.

Keywords: Kinsley Power Systems, Waltham , Senior Medical Writer, Other , Waltham, Massachusetts