Green Key Resources
Artificial Intelligence & Digital Innovation Medical Writer -Associate Director/
Green Key Resources, Boston, Massachusetts, us, 02298
Artificial Intelligence & Digital Innovation Medical Writer - Associate Director/Principal
Looking for experience as Lead Project MW on multiple types of clinical documents. Position is focused on integrating AI and digital innovation in medical writing.
Direct message the job poster from Green Key Resources.
Overview
Lead medical writing efforts for clinical documentation and regulatory submissions in a hybrid work environment.
Collaborate with cross‑functional teams to ensure quality and compliance of clinical documents.
Mentor junior medical writers and manage documentation teams effectively.
Contribute to process improvement initiatives and implement innovative technologies.
Coordinate preparation of clinical modules for regulatory submissions globally.
Ensure timely production of high‑quality clinical documents for study start, conduct, and completion.
Act as subject matter expert in medical writing for transversal initiatives.
Maintain awareness of current clinical documentation requirements and standards.
Key Responsibilities & Duties
Prepare and coordinate clinical documents for regulatory submissions and study reports.
Collaborate with Clinical Trial Teams and Project Teams to ensure document accuracy and compliance.
Mentor and train junior medical writers, fostering professional growth.
Implement process improvements and innovative solutions for document preparation.
Coordinate with external services and review documentation generated by contractors.
Ensure consistency across regulatory documents and manage database modifications.
Provide expertise in clinical development methodologies and regulatory environments.
Represent medical writing in cross‑functional initiatives and projects.
Job Requirements
Master’s degree or Ph.D. in life sciences, PharmD, or medically qualified.
Minimum of 6 years of experience in medical writing, with leadership roles preferred.
Proficiency in clinical documentation standards and regulatory requirements.
Strong skills in Microsoft Word and electronic document management systems.
Excellent interpersonal and leadership abilities in a multicultural environment.
Experience with process improvement and innovative digital technologies.
Native English speaker or proven proficiency in English communication.
Knowledge of company‑targeted therapeutic areas is desirable.
Other Details
Seniority level: Director
Employment type: Full‑time
Job function: Writing/Editing
Industry: Pharmaceutical Manufacturing
#J-18808-Ljbffr
Direct message the job poster from Green Key Resources.
Overview
Lead medical writing efforts for clinical documentation and regulatory submissions in a hybrid work environment.
Collaborate with cross‑functional teams to ensure quality and compliance of clinical documents.
Mentor junior medical writers and manage documentation teams effectively.
Contribute to process improvement initiatives and implement innovative technologies.
Coordinate preparation of clinical modules for regulatory submissions globally.
Ensure timely production of high‑quality clinical documents for study start, conduct, and completion.
Act as subject matter expert in medical writing for transversal initiatives.
Maintain awareness of current clinical documentation requirements and standards.
Key Responsibilities & Duties
Prepare and coordinate clinical documents for regulatory submissions and study reports.
Collaborate with Clinical Trial Teams and Project Teams to ensure document accuracy and compliance.
Mentor and train junior medical writers, fostering professional growth.
Implement process improvements and innovative solutions for document preparation.
Coordinate with external services and review documentation generated by contractors.
Ensure consistency across regulatory documents and manage database modifications.
Provide expertise in clinical development methodologies and regulatory environments.
Represent medical writing in cross‑functional initiatives and projects.
Job Requirements
Master’s degree or Ph.D. in life sciences, PharmD, or medically qualified.
Minimum of 6 years of experience in medical writing, with leadership roles preferred.
Proficiency in clinical documentation standards and regulatory requirements.
Strong skills in Microsoft Word and electronic document management systems.
Excellent interpersonal and leadership abilities in a multicultural environment.
Experience with process improvement and innovative digital technologies.
Native English speaker or proven proficiency in English communication.
Knowledge of company‑targeted therapeutic areas is desirable.
Other Details
Seniority level: Director
Employment type: Full‑time
Job function: Writing/Editing
Industry: Pharmaceutical Manufacturing
#J-18808-Ljbffr