Medical Writer II
Medical Writer II
We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
- Interprets, analyzes, writes, formats, and produces Clinical Development Documents, such as final Clinical Study Reports, abstracts, white paper reviews and regulatory agency submission documents on a given product or medical question across several therapeutic areas.
- Provides the basis of introductions/conclusions for production of reports for select medical literature.
- Works with various teams (both internal and external) involved in the clinical study or group generating the data to engage all parties who may contribute to writing sections of documents, review and/or approve to ensure final approved documents are generated according to planned timelines and function in the capacity of editor.
What your responsibilities will be
- Authors the first and subsequent drafts of clinical study reports from data generated from clinical studies, using ability to understand and interpret the data from tables and graphs and be able to place them in written and diagrammatic format with the medical/scientific perspective.
- Utilizes statistical and medical literature evaluation skills to compare data and potential citations for generation of these documents. Uses appropriate style, grammar, and flow and assumes responsibility for completeness, accuracy, and content of the prepared document.
- Organizes the material with co-authors, format, and co-ordinates processes for internal review and prepares the clinical report for final sign off. Ensures that the production of final report is according to departmental SOPs.
- Authors the first (and subsequent) drafts of documents or abstracts/posters from data from clinical studies or other sources such as drug safety, or from published sources.
- Provides authorship support to Medical Directors for protocol shells, updating the investigator brochures, annual safety reports and for regulatory documents such as sections of Biological License Applications to FDA and other regulatory agencies.
- Interfaces and assists the physicians, key opinion leaders that may be involved in preparing documents to provide editorial assistance.
- Assists publications planning team in integrating the science of Talecris products and relevant clinical study results into the strategic planning and execution of product publication.
- Ensures implementation of quality control (QC) and other critical quality aspects for final documents. Drives document production timelines according to established plans.
- Maintains Clinical Study Registry and Results Disclosure, within current worldwide regulations, interfacing and uploading clinical protocol registration data and clinical study report disclosure data to FDA CT.gov, EU, and other worldwide website registries.
- Accountable for worldwide registration and results disclosure of clinical studies. Oversees and supports processes for review and approval of new or updates of existing SOPs relevant to medical writing.
- Works on complex assignments requiring in-depth evaluation of variable factors. Determines the appropriate methods and/or procedures to be used for new assignments. With sustained high levels of technical proficiency, performance, and accomplishments, has earned a reputation as an emerging leader in the field. Some barriers to entry exist (i.e., dept/peer review). Level at which career may plateau.
- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise.
Who you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Excellent scientific, technical and clinical studies knowledge.
- Excellent knowledge of MS Office, Viso, ISI Writer, Reference Manager, and medical/scientific search/retrieval tools.
- Excellent analytical, organizational, project management and communication (oral and written) skills.
- Ability to multi-task
- Bachelor's degree in science or related field with coursework in biology, pharmacy, or related areas. Advanced degree (MS, PhD, or PharmD) preferred
- Typically requires 8 years of pharmaceutical experience in clinical research/regulatory medical writing. (If PhD in statistics, equivalency is 5 years of pharmaceutical experience.)
What we offer
- It's a brilliant opportunity for someone with the right talents.
- Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications.
- We'll help you grow professionally.
- Flexibility for U Program: Hybrid Model
- Benefits Package
- Contract of Employment: Permanent position
If you're interested in joining our company and you have what it takes, then don't hesitate to apply. We look forward to receiving your application. Grifols is an equal opportunity employer.