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Medical Writer Clinical IV (ABBVJP00015396)
Job description
Job Description
Prepares technical documents to support both domestic and international regulatory submissions. Incorporates text, graphs, charts, tables, and statistical analysis. Proofreads, circulates, edits, assembles, inspects, and duplicates product submissions. Requires a PhD, PharmD, or MS degree. Reports will be written from scratch, so advanced knowledge of clinical studies is mandatory. Qualified candidates need to have experience in the reporting of: Clinical Study Reports, Investigative Brochures, IND's, NDA's, annual reports. Writing of Briefing Documents is sometimes preferred.10+ years experience required. Requires a Clinical Background
NOTES FROM INTAKE CALL:
1) What hours and days will this person be working?
2) What are the top 5 skills/requirements this person is required have?
a. Required Skill 1:
b. Required Skill 2:
c. Required Skill 3:
d. Required Skill 4:
e. Required Skill 5:
3) What years of experience, education, and/or certification is required?
4) What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
5) What is the environment that this person will be working in (i.e. group setting vs individual role)?
6) Is any testing required for this role?
7) 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)?
8) Other notable details from the hiring manager about this role
About Kyyba:
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Disclaimer:
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.
Rewards:
Medical, dental, vision
401k
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client
SELECT AWARDS
Prepares technical documents to support both domestic and international regulatory submissions. Incorporates text, graphs, charts, tables, and statistical analysis. Proofreads, circulates, edits, assembles, inspects, and duplicates product submissions. Requires a PhD, PharmD, or MS degree. Reports will be written from scratch, so advanced knowledge of clinical studies is mandatory. Qualified candidates need to have experience in the reporting of: Clinical Study Reports, Investigative Brochures, IND's, NDA's, annual reports. Writing of Briefing Documents is sometimes preferred.10+ years experience required. Requires a Clinical Background
NOTES FROM INTAKE CALL:
1) What hours and days will this person be working?
2) What are the top 5 skills/requirements this person is required have?
a. Required Skill 1:
b. Required Skill 2:
c. Required Skill 3:
d. Required Skill 4:
e. Required Skill 5:
3) What years of experience, education, and/or certification is required?
4) What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
5) What is the environment that this person will be working in (i.e. group setting vs individual role)?
6) Is any testing required for this role?
7) 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)?
8) Other notable details from the hiring manager about this role
About Kyyba:
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Disclaimer:
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.
Rewards:
Medical, dental, vision
401k
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client
SELECT AWARDS
- An INC 5000 company for 10 years
- Corp! Michigan Economic Bright Spots
- Crain’s Detroit Business Top Staffing Service Companies in Detroit
- TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions
- Best of MichBusiness winner in HR Wizards & Partnerships
- Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest
- 101 Best & Brightest Companies to Work for in Michigan
Required profile
Experience
Level of experience: Expert & Leadership (>10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory. Other Skills
- Report Writing
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