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21 days old

Sr. Medical Writer

Kelly Services
Chicago, IL 60684
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Senior Medical Writer** at a prestigious Fortune 500 company working in **North Chicago, IL.**


**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes, however your resume must be received via the Submit Resume button included within.


**Job Title: Senior Medical Writer**


**Pay: $48-52 per hour**


Purpose:

Describe the primary goals, objectives or functions or outputs of this position.

The Senior Medical Writer is responsible for providing clinical regulatory document support to the clinical teams, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the clinical writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups (e.g., PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of clinical regulatory submissions.


Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

Serves as medical writing lead on clinical regulatory documents. Works closely with the Regulatory team(s) on document strategies. Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US).

Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained.

Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with clinical regulatory requirements.

Effectively communicates clinical regulatory document deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates and with an appropriate quality level. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate.

Understands, assimilates, and interprets sources of information with appropriate guidance/direction from development teams. Interprets and explains data generated from a variety of sources. Verifies that results are consistent with protocols. Challenges conclusions when necessary. Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies.

Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs.

Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to clinical regulatory documents.

Works with Regulatory Quality Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate) and works with team to draft responses as necessary.

Knowledgeable of US and international regulations, requirements, and guidance associated with clinical regulatory document preparation and submissions. Must continually train/be compliant with all current industry requirements as they relate to clinical regulatory submissions, including electronic submission/approval standards.

Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. eDocs and eCTD databases). May mentor and provide guidance to more junior medical writers and/or external vendor/agencies. Implements tactical process improvements.


Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience.

American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.

3 years relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D.

3 years experience in experimental design and clinical/preclinical data interpretation preferred.

Knowledgeable of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions.

Knowledge and experience with Common Technical Document content templates. Working knowledge of current electronic document management systems and information technology.

Excellent written and oral communication skills. Experience in working with collaborative, cross-functional teams, including project management experience.

Ability to assimilate and interpret scientific content and translate information for appropriate audience.

Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.

Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment.


What are the top 3-5 skills requirements should this person have?


1: Experienced in writing Phase 2-4 clinical study reports.

2: Demonstrated ability in leading cross-functional teams

3: Demonstrated ability to manage timelines and execute to due date.

4: Excellent organizational skills, attention to detail, and strong oral and written communications skills


What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

Examples: Bachelor of Science; 4 year pharma, health care, or regulated industry

Writing clinical summary of safety and clinical summary of efficacy a plus.

What type of environment is this person working in?

o Group setting

o Individual Setting

o Combination of both

Combination

Work Schedule (Define days,# of hours)/ Is Overtime offered or required? If yes, how many hours, what impact to scheduled working hours?

Very little OT expected. 8 hours per day, core hours central 9 to 3, half hour or hour for lunch

Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? Full time remote


Is the worker onshore or offshore? (If offshore confirm with manager that the worker will align to a USD Cost Center for invoicing purposes.) If no, escalate to Operations Manager onshore


Will there be Domestic and/or International Travel? If yes, list proposed countries and % of time travelling: No travel expected.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-02-03 Expires: 2021-03-06

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Sr. Medical Writer

Kelly Services
Chicago, IL 60684

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