Senior Medical Writing Specialist (REMOTE)
Senior Medical Writing Specialist (REMOTE)
DivIHN Integration Inc
United States
See who DivIHN Integration Inc has hired for this role
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.
Visit us at https://divihn.com/find-a-job/ to learn more and view our open positions.
Please apply or call one of us to learn more
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
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
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.
Visit us at https://divihn.com/find-a-job/ to learn more and view our open positions.
Please apply or call one of us to learn more
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.
- 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
- 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.
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
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.
-
Seniority level
Associate -
Employment type
Full-time -
Job function
Marketing, Public Relations, and Writing/Editing -
Industries
Software Development
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