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Senior Medical Writer, Promotional Review

市场运营限定地区(需当地身份)
公司Lifelancer
薪资$115,000 - $125,000/年
工作地点United States
地域资格限定地区(需当地身份)
时区要求日间重叠约 9 小时,基本正常作息
用工类型Full Time
发布时间2 天前
数据来源Himalayas
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注意地域限制:该职位明确限定在 United States 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。

Job Title: Senior Medical Writer, Promotional Review
Job Location: Remote, California, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Senior Medical Writer - Make an Impact at the Forefront of Innovation
The Senior Medical Writer provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients and demonstrates subject matter and therapeutic area expertise. The Senior Medical Writer may assist program manager. The role involves collaborating with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

What You'll Do:
•Serve as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies.
•May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
•Review routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
•Ensure compliance with quality processes and requirements for assigned documents. Provide input on and independently develops best practices, methods and techniques for achieving optimal results, including various client specific processes.
•May assist in program management activities. Identify and resolve out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
•Represent the department at project launch meetings, review meetings, and project team meetings.

Education & Experience Requirements:
•Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
•Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
•Experience working in the pharmaceutical/CRO industry preferred
•Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills, Abilities:
•Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
•Strong project management skills
•Excellent interpersonal skills including problem solving
•Strong negotiation skills
•Excellent oral and written communication skills with strong presentation skills
•Significant knowledge of global, regional, national and other document development guidelines
•In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
•Great judgment and decision-making skills
•Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

Working Conditions and Environment:
•Work is performed in an office environment.
•Exposure to electrical office equipment.
•Occasional drives to site locations with occasional travel both domestic and international.
•Long, varied hours required occasionally.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.
Compensation and Benefits
The salary range estimated for this position based in California is $115,000.00–$125,000.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
  • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit:

This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.
Originally posted on Himalayas

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