Medical/Regulatory Writer - US based preferred

Closed Posted 3 years ago Paid on delivery
Closed Paid on delivery

Hello - I am looking for a skilled Medical/Regulatory Writer.

MUST have following skills:

*Minimum of BS/BA degree in science (Masters or PhD preferred) with at least 5 years of regulatory writing and submission experience

*Ability to work with complex projects, within cross-functional teams, and under tight timelines

Requires attention to accuracy, quality, and adherence to format and stylistic requirements

Excellent grammatical and communication skills, both written and oral

Expertise in MS WORD

Responsibilities will include, but are not limited to, the following:

Author regulatory submission documents, eg, CSRs, CTD summary documents (2.7.3, 2.7.4, possibly 2.7.1, and 2.7.2), and Clinical Overviews (2.5), Integrated Summaries of Efficacy and Safety, Pediatric Investigation Plans, Proposed Pediatric Study Requests, Requests of Product Specific Waivers, and applications for Orphan Drug Designations

Prepare IBs (FIH/other, IB updates)

Provide direction to team on content and optimal data presentation/summarization in the document

Develop the strategy for document preparation and the document review processes, including the management of timelines

Facilitate document review meetings and discussions

May act as medical writing lead on submissions or new programs, including early development programs

May contribute to Clinical Trial Data Sharing activities, including act as the lead for team review and redaction of private patient and/or confidential commercial information from documents and/or review documents prepared for redaction

Complete required training on time

MUST SUBMIT samples of Recent experience writing regulatory submission documents, eg, CSRs, CTD summaries or clinical overview, briefing books

ADD the word "MEDICAL" to the top of your message so that I know you have read this message in its entirety. If you do not, I will delete your message for sending spam.

Medical Writing Medical Technical Writing Health

Project ID: #25590268

About the project

13 proposals Remote project Active 3 years ago

13 freelancers are bidding on average $380 for this job

muiguevans

Hello client, I have gone through your project specification you have provided and are doable for me. I am a professional writer and would like to work on your project. You will get your work done fast and accurately, More

$250 USD in 1 day
(80 Reviews)
5.8
johnwanjiku

Hi, Hope you are fine I understand your project that state:Medical/Regulatory Writer - US based preferred Customized articles, essays, and business plan services are available for those people who want quality and nat More

$250 USD in 7 days
(19 Reviews)
4.5
Zarinaali

MEDICAL Hi there I have an excellent medical writer who can help you with this paper. Please send me a message to discuss more about details.

$500 USD in 7 days
(14 Reviews)
4.4
coozmoobusiness

MEDICAL Hi, there I hope you are doing great today. Are you looking for a high-quality and well-researched medical written by a professional with more than 7 years of experience in the medical field? As a former privat More

$500 USD in 7 days
(3 Reviews)
3.7
taliarehan

"MEDICAL" Hey there, I am a dedicated freelancer assisting the freelance community for finest quality with dedication. I have been into professional writing for over a decade now. I guarantee 0% plagiarism, excellen More

$250 USD in 5 days
(5 Reviews)
4.2
PradeepBaghel2

MEDICAL Dear Client, I am a biomedical engineer and a medical research consultant. I help organizations gain relevant custom insights/intelligence as per their needs related to R&D, regulatory, and market due-diligenc More

$500 USD in 7 days
(0 Reviews)
0.0
CinthyaCelina27

MÉDICO Soy estudiante de medicina, sobre saliente en mi clase. Puedo ayudarle de manera eficaz , transparente comprometida con la responsabilidad que debe de tener este trabajo, al mismo tiempo enriquecerme de conoci More

$250 USD in 30 days
(0 Reviews)
0.0
vikideepa8822d

I am medical summarizer, I had well knowledge about summarize the medical records.

$283 USD in 10 days
(0 Reviews)
0.0
eskeebaugh

MEDICAL Dear Hiring Manager, I am writing to express my interest in your Medical/Regulatory Writer position. Because I am new to Freelancer, I can provide additional information and writing samples to introduce you t More

$500 USD in 7 days
(0 Reviews)
0.0
shaikhmohsin881

I am hardworking I complete my work within given time Relevant Skills and Experience I have 2 year experience in Regulatory Affairs department

$556 USD in 10 days
(0 Reviews)
0.0