Job Details:-
Hiring Organization: Rangam Consultants Inc.
Position Name: Medical Copywriter/Medical Editor(Proofreading/Formatting)
Qualification: Graduation
Industry: Private
Employment Type: [‘CONTRACTOR’]
Work Hours: 8
Salary: $20 To $30/An Hour
Location: Remote, United States
Go to Medical Copywriter/Medical Editor(Proofreading/Formatting) and start working at home.
Position Description:
Manager’s Update:
- Bachelor’s degree would be Desired but prior 5+ years of exp. without a degree will also work for this role.
- Must be familiar to work within a regulatory operation
- Previous documentation Specialist or Writer would be great fit for this position
- Must have a documentatin experience
- Must have exp. with MS word & PDF
- Experience working with documentation in a regulated industry (e.g., pharmaceutical, legal, government)
- Clinical Regulatory Operations & Standards group
- Must have a regulated industry experience.
- Exp. with document management system would be a plus but not a deal breaker
- Must be familiar with regulatory affairs
- Must have a documentation formatting experience
- Word processiong exp. would be a plus for this role
- For Level I & Level II fresh graduate will also work but need to have a degree in English/Communication
We are open to fully remote candidates; candidates local to Lake County may be required to be onsite a certain number of days a week. It will be an initial 6 month contract with potential to extend.
Please Look for direct experience
Formatting Regulartory documents in MS Word
– Regulartory operations
– submission Operations
– document processing
– Submission readiness
Summary:
The Clinical Word Processing group provides specialized word processing services to clients across various functional areas in the company. The Senior Word Processing Coordinator is responsible for formatting regulated clinical documents to ensure they comply with company standards and strict industry requirements, importing documents into the Regulatory Information Management system (RIMS) [i.e., electronic document management system], ensuring documents have the correct RIMS metadata and properties assigned, and verifying that documents correctly render from Word to PDF in the system. Other responsibilities include providing RIMS business support, troubleshooting issues in Word, and bookmarking/hyperlinking PDFs in Adobe Pro.
Must have:
- Advanced Microsoft Word knowledge (e.g., TOC building, cross referencing, table formatting, and troubleshooting skills)
Desired:
- Knowledge of Adobe Pro, including bookmarking and hyperlinking
- MS Word certification
- Experience working in a document management system
- Experience working with documentation in a regulated industry (e.g., pharmaceutical, legal, government)
Description:
- Proofreads documents for accuracy and consistency. Coordinates and communicates with other word processing team members for consistency for all documents.
- Ensures completion of work to meet multiple client deadlines.
- The Senior Word Processing Coordinator II is responsible for formatting, proofing, and completion of clinical protocols, clinical study reports, investigator brochures, summaries, and other related clinical documents.
- Provides regulatory document formatting support to the Medical Writing, Clinical, and Pharmacovigilance Teams, ensuring successful preparation of high-quality submission-ready documents.
- Ensures styles and formatting are consistent with defined eSubmission standards so that the documents created in MS Word correctly render to PDF.
- Imports and routes documents in the submission system ensuring proper naming conventions and document properties.
Responsibilities:
- Must continually train/be compliant with all current industry requirements as they relate to regulatory submissions, including electronic submission/approval standards.
- Populates document properties and ensures correct naming conventions are used per the eSubmissions System file naming conventions.
- Confirms formats and styles are consistent with those in the clinical regulatory templates, when applicable.
- Accountable for meeting the main objectives of assigned word processing projects within established timelines and with an appropriate quality level.
- Provides ongoing support for Medical Writing, Clinical, and other functional areas; acts as a liaison between eDocs support and Medical Writing as needed.
- Processes, proofreads, verifies and manages various clinical regulatory documents, ensuring they are submission-ready for publishing with an appropriate level of accuracy and consistency.
- Communicates regularly with colleagues and management regarding timelines and conflict to timelines for word processing requests, eSubmissions issues, and document completion dates.
- Responsible for effective communication among team members. Ensures all electronic document deliverables are processed and completed in alignment with timelines.
- Ensures document styles and formatting are consistent with defined eSubmissions standards, so that documents created in MS Word are correctly rendered to PDFs.
- Accountable for providing services and results on time, accurately and consistent with expectations.
- Maintains knowledge of eSubmissions styles and formatting standards.
- Participates in process improvement activities.
Qualifications:
- Bachelor of Science or Bachelor’s degree in English or Communications will be considered.
- 5+ years relevant pharmaceutical industry experience in a related area such as medical writing, quality, regulatory, clinical research, or product support/Research & Development desired.
Open to bringing someone in at the coordinator I or II levels (1+ years, 2+ years) – Pay rates will reflect level I or level II.
Intake Notes
1) What hours and days will this person be working: Monday – Friday 8am CT-4:30pm CT (start and stop time is flexible 1 hour in either direction)
2) What are the top 5 skills/requirements this person is required have?
a. Required Skill 1: Computer literacy; proficient formatting skills in Microsoft Word
b. Required Skill 2: independent learner; must be comfortable proactively asking questions
c. Required Skill 3: proven ability in the strict application of standardized requirements (style guides, checklists, job aids, etc)
d. Required Skill 4: proven ability to understand new technical concepts and extrapolate to new situations
e. Required Skill 5: strong independent time management skills
3) What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
Proficiency in Adobe and ISI toolbox, experience working in a document management system; knowledge of Common Technical Document (CTD) format
4) Other notable details about the environment from the hiring manager about this role.
Job comprises continuous short term assignments (1-2 days) conducted in Word or Adobe, contractor is expected to complete assignments efficiently with minimal oversight (after initial training period). management/mentor aways available to provide guidance but due to the independent nature of the work, contractor must be comfortable with proactively asking questions. Computer literacy is essential.
5) What positions/background experience do you feel are successful in this role
Experience in the strict application of technical rules/requirements and/or following checklists. Technical roles.
Job Type: Contract
Salary: $12.17 – $38.52 per hour
Benefits:
- Health insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
- Associate (Preferred)
Experience:
- document management systems: 4 years (Preferred)
- Proofreading: 4 years (Preferred)
- Adobe Pro, including bookmarking and hyperlinking: 4 years (Preferred)
- Advanced Microsoft Word: 4 years (Preferred)
- formatting regulated clinical documents: 4 years (Preferred)
Work Location: Remote
Full Job Description
Rangam Consultants Inc. – Medical Copywriter/Medical Editor(Proofreading/Formatting)
Some rules which are followed in good companies by good employees. About what you should know so that you may easily adapt them, given below.
- Company always wants you to be on time and you should be.
- Take less leave from the office.
- Focus on your work and try to learn more.
- Speak from your work not for your mouth.
- Keep on trying to get new things from your seniors, regarding your profile.
- Raise your point but only then when you are 100% sure about your point.
- Never hurry because haste makes waste.
- For earning some extra points than others. Just play out of your comfort zone.
- Always respect your seniors.
- Learn from mistakes made by you and others and do not try to repeat them.
How to apply:
- All the eligible candidates can apply for This Job as mentioned below
- Read official notification carefully From the Official Website.
- Read Notification Carefully Before Apply.
- Fill The Application Form (Link Is Given Below)
- Attach Required Document and Passport Size Photo with Signature.
- Then Submit. Done.
