about 2 months ago
My client, a clinical stage biopharma developing novel products in the oncology sphere, is looking to take on an experienced Medical Writer at the Director level to oversee the develoment of clinical protocols and associated regulatory submissions.
- Mentors and leads less experienced medical writers on complex projects, as necessary.
- Acts as lead for assigned writing projects.
- Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
- Develops or supports a variety of documents that include, but not limited to:
- Clinical study protocols and clinical protocol amendments;
- Clinical study reports;
- Patient narratives;
- Clinical development plans;
- IND submissions and annual reports;
- Integrated summary reports;
- NDA and (e)CTD submissions;
- Investigator brochures, as well as;
- Clinical journal manuscripts, clinical journal abstracts, and client presentations.
- Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
- 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.
- Serves as peer reviewer on internal review team providing review comments on draft and final documents
- 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
- Performs on-line clinical literature searches, as applicable.
- Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing
- Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
- Bachelor's degree in Science, Medical Technology, English, or equivalent experience.
- American Medical Writers Association (AMWA) certification is desired, with a specialty in Editing/Writing or Pharmaceutical.
- Minimum 2 years relevant professional experience, in a related area such as R&D, Technical Product Development, Quality, Regulatory Affairs, Clinical Research, or Medical Writing.
- 1-4 years writing experience as a medical writer in the health care industry preferred.
- 1-4 years experience in experimental design and data interpretation preferred.
- Knowledge of ADD products desirable.
- Good written and oral communication skills.
- Superior attention to detail.
- Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
- Fluent in word processing, flow diagrams and spreadsheets.
- Good working knowledge of personal computer software programs in Windows environment.
- Good communication, interpersonal, and team skills.
- Ability to critically review own work before sending out for internal/external review by team.
- Knowledge of regulations and standards affecting IVDs and Biologics