Description
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.
Summary
- 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 Baxter 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.
