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Job Title : Medical Writer

Job Location : California USA

Job Location Type : Remote

Job Contract Type : Fulltime

Job Seniority Level : MidSenior level

Would you like to join an international team working to improve the future of healthcare Do you want to enhance the lives of millions of people Grifols is a global healthcare company that since 1909 has been working to improve the health and wellbeing of people around the world. We are leaders in plasmaderived medicines and transfusion medicine and develop produce and market innovative medicines solutions and services in more than 110 countries and regions.

Location :

Remote candidate must be located in one of the following states AZ CA CO DC FL GA ID LA MA MD ME MI MO MT NC NE NJ OR PA RI SC TN TX UT VA WI

Summary

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.

Primary Responsibilities

• 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 coauthors format and coordinates 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 Grifols 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.

Additional Responsibilities

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.

Knowledge Skills & Abilities

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 multitask.

Requirements

Bachelor's degree in science or related field with coursework in biology pharmacy or related areas. Advanced degree (MS PhD or PharmD) preferred.

Medical Writer 1 : Typically requires 5 years of pharmaceutical experience in clinical research / regulatory medical writing. (If PhD equivalency is 2 years of pharmaceutical experience.)

Medical Writer 2 : Typically requires 8 years of pharmaceutical experience in clinical research / regulatory medical writing. (If PhD in statistics equivalency is 5 years of pharmaceutical experience.)

Depending on the area of assignment directly related experience or a combination of directly related education and experience and / or competencies may be considered in place of the stated requirements. Example : If a job level requires a Bachelor’s degree plus 4 years of experience an equivalency could include 8 years of experience an Associate’s degree with 6 years of experience or a Master’s degree with 2 years of experience.

Pay Scale

The estimated pay scale for the Medical Writer role based in the United States (nonCalifornia) is$90000.00 $140000.00 per year. Additionally the position is eligible to participate in 8% of the company bonus pool (depending on level of role). We offer a wide variety of benefits including but not limited to : Medical Dental Vision PTO 9 paid Holidays per year plus 2 additional floating holidays up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education experience skillset knowledge where the role is performed internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909 Grifols has been a family company that prides itself on its familylike culture. Our company has more than tripled over the last 10 years and you can grow with us!

For California

The estimated pay scale for the Medical Writer (12) role based in California is$100000.00 $150000.00 per year.

Occupational Demands

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 68 hours per day. Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

Third Party Agency And Recruiter Notice

Agencies that present a candidate to Grifols must have an active nonexpired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.

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Key Skills

Clinical Research,Adobe Acrobat,FDA Regulations,Technical Writing,Biotechnology,Clinical Development,Clinical Trials,Microsoft Powerpoint,Research Experience,Document Management Systems,Word Processing,Writing Skills

Employment Type : Full Time

Vacancy : 1