In search of a physician career change opportunity or a new non-clinical career? An executive search firm is working with a biopharmaceutical company in Summit NJ, to fill the position of Permanent Medical Writer (Scientific & Medical writing).
Responsibilities will include, but are not limited to, the following:
1.Working with other relevant line functions, prepare clinical documents in support of regulatory submissions, including Investigator’s Brochures, clinical study reports, integrated summaries of efficacy and safety, registration dossiers, and responses to health authorities.
2.Participate in study and clinical team meetings and assist the teams in resolving issues related to document preparation.
3.Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
4.Prepare templates for clinical documents that are consistent with FDA and ICH guidelines and with electronic submission guidelines.
5.Develop the strategy for document preparation, including time frames that meet or exceed company standards and the document review processes.
6.Facilitate document review meetings and discussions.
7.Participate in the development of outsourcing plans for medical writing.
8.Manage outsourced medical writing projects.
9.Review work of other writers (in-house or contract) for accuracy, quality, focus, and adherence to format and stylistic requirements.
10.Train and guide other writers (in-house or contract) in company policies and procedures related to document preparation.
11.Assist with transferring and presenting clinical / regulatory data to Marketing for journal submissions.
Skills/Knowledge Required:
•Ability to interpret and analyze scientific and medical data
•Proficient with the use of Word and electronic templates
•Familiarity with ICH and health authority guidelines pertaining to submission relevant documents
•Scientific or medical background as applicable
•Excellent grammatical and communication skills, both written and oral
•Knowledge of electronic document repository use
•Knowledgeable in industry trends for study reports and international dossier preparation, including electronic document submissions (eCTD)
•Ability to train others writing skill sets
•Experience working with CROs
•Ability to work with complex projects and within cross-functional teams
•Ability to search and scan various internal and external databases, i.e. Pub Med, Gen Bank, Library of Congress. Identify internal resource information that would aid in completion of the task.
•Experience writing all types of clinical and regulatory documents
If you are interested in this opportunity, please email your CV and a cover letter to info at prnresource.com, and we will forward it to the executive search firm looking to fill the position.
R – OD 3-18
