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Senior Medical Writing Specialist
One Baxter Parkway Riverwoods, IL 60015 US
Job Description
Target Pay Rate: 60-75.53/hr **salary will be commensurate with experience
Job Description:
The healthcare industry requires that we abide by regulations from all around the world. Part of the requirements is to produce clinical documents which support the safety and efficacy of our products. The Senior Medical Writing Specialist in Worldwide Medical Advanced Surgery will write and edit clinical documents to support regulatory submissions for relevant products. The ideal candidates must have a scientific background and be fluent in English (both writing and speaking). \
Essential Duties and Responsibilities:
- With oversight, develops high quality clinical documents ensuring scientific excellence and regulatory compliance. The development process includes writing, interpreting, and summarizing clinical and non-clinical data, compiling information, and ensuring delivery within timelines.
- Clinical documents may include investigator brochures, protocols, clinical study reports, integrated reports, clinical sections of core technical documents/new drug applications/briefing documents per regulations, manuscripts/abstracts for publication and/or presentation.
- Ensure compliance of clinical documents with national and international regulatory requirements and guidelines and procedures (as applicable).
- Work closely with cross functional team members and serve as MW representative at study team meetings.
- Prepare document timelines, with guidance from manager, as needed.
- Conduct literature searches.
- Develop deeper knowledge of specific therapeutic areas.
Qualifications:
- Experience in scientific and/or medical writing.
- Experience in the analytical evaluation of scientific data and written or oral presentation in a logical, clear, concise manner.
- Strong organizational skills and meticulous attention to detail.
- Familiarity with clinical trial-related and regulatory clinical submission templates and documents
- Ability to apply global regulatory authority regulations and/or guidance.
- Manage multiple projects with competing priorities.
- Experience working in a team environment (remotely) as well as independently.
- Medical statistics knowledge
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, OneNote, Outlook, Teams
Education and/or Experience:
- The Senior Medical Writing Specialist must have a BS or MS in scientific or clinical discipline with excellent writing skills. 5 years of on-the-job experience in scientific/medical writing (e.g., clinical trial and regulatory documents) preferred but not mandatory.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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