Senior Medical Writing Specialist (REMOTE)

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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For further inquiries regarding the following opportunity, please contact one of our Talent Specialists

Divya at 224 369 2969

Sivanesan at 224 369 0756

Title: Senior Medical Writing Specialist (REMOTE)

Location: Remote

Duration: 6 Months with possible extension

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 Client 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 Mircosoft 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.
  
  

Purpose of this Role & Key Requirements / Day to Day life:

Looking for medical writers in regulatory settings such as the FDA, with experience using Microsoft applications to create documentation and presentations in PowerPoint. Understanding medical statistics provides some review clinical research and some familiarity with publishing. deeper experience in the medical sector in all three vascular phases

Top Skills

• Medical Writing
• Clinical
• Regulatory document
• An engineering background is nice to have
  
  

Medical devices Industry Experience: Not required

Education: Ph.D or Master’s or MD or bachelor’s degree or equivalent

# of Years if required Experience: Minimum 3+ years of experience

Non-Local Candidates OK Yes

Interview Process: 3 rounds (First two rounds initial screening with HM)

Hours of Operation: Normal

Travel Involved? No

About Us

DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.