Senior Medical Writing Specialist Job at Planet Group, Baxter County, AR

TStkKzJHSEhya1E4RzZXWmYwajQ5NndHRGc9PQ==
  • Planet Group
  • Baxter County, AR

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.

Job Tags

Remote job, Contract work, Worldwide,

Similar Jobs

Sephora

DE&I Business & Industry Impact Initiatives Manager Job at Sephora

 ...world bring to life our purpose: to expand the way the world sees beauty by empowering the Extra Ordinary in each of us. We are united...  ...areas, delivering impactful training programs, and driving industry-wide initiatives to address systemic inequities in beauty and retail... 

Beacon Hill

Sales Recruiter IL Job at Beacon Hill

 ...Our client, a rapidly growing company in the Southwest suburbs, seeks an experienced Recruiter to oversee the entire recruiting process. This is an exciting chance to lead the recruiting function and collaborate closely with company leaders. Key Responsibilities: Create... 

Point32Health

Community Health Worker (CHW) - Public Plans Job at Point32Health

 ...Job Description Job Summary The Community Health Worker (CHW) assists members in managing their health goals in the community. The CHW role works collaboratively with team members of Point32Health Integrate Care Management team to increase member knowledge, motivation... 

Links Global USA

Creative Designer/Web Designer/Graphic Designer Job at Links Global USA

 ...Description:We are seeking a highly creative and skilled Creative Designer/Web Designer/Graphic Designer to join our marketing communications...  ...and platforms.Optimize graphics and web layouts for various digital and print channels to enhance user experience and engagement.... 

Calbee America

Warehouse/Logistics Manager Job at Calbee America

Calbee America, Inc. is looking for a Warehouse Manager/Logistics Manager for our facility in Fairfiled, CA. Calbee America, Inc offers...  ...RESPONSIBILITIES Plan and execute the daily and weekly shipping and production schedule based on available shipping containers...