Description
SUMMARY OF POSITION
We are seeking a skilled Medical Writer to develop high-quality clinical and regulatory documents in compliance with industry standards and regulatory guidelines. The ideal candidate will collaborate with cross-functional teams, including Clinical, Regulatory, Biostatistics, and Medical Affairs, to create well-structured, scientifically accurate, and regulatory-compliant documents.
JOB REQUIREMENTS
Regulatory Document Writing:
o Prepare and author clinical and regulatory documents, including but not limited to:
? Clinical Study Protocols (CSPs) and Protocol Amendments
? Clinical Study Reports (CSRs)
? Investigator's Brochures (IBs)
? Informed Consent Forms (ICFs)
? Common Technical Document (CTD) Modules (e.g., Module 2.5 Clinical Overview, Module 2.7 Clinical Summary)
? Briefing Documents for Regulatory Authorities (e.g., FDA, EMA)
? Periodic Safety Reports
? Risk Management Plans (RMPs) and Pediatric Investigation Plans (PIPs)
? New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAAs)
? Responses to regulatory queries
Clinical Development Support:
o Develop and maintain clinical development plans, clinical trial protocols, and statistical analysis plans
o Collaborate with clinical teams to ensure alignment of clinical documents with study objectives and regulatory requirements
o Interpret complex scientific and clinical data and communicate findings clearly and concisely
Regulatory Compliance & Standards:
o Ensure documents comply with ICH, GCP, FDA, EMA, and other applicable regulatory agency guidelines
o Maintain up-to-date knowledge of regulatory writing best practices, industry trends, and evolving guidelines
Collaboration & Review:
o Work closely with cross-functional teams, including medical, clinical, regulatory, statistical, and quality assurance teams
o Review and edit documents prepared by internal teams or external vendors to ensure scientific accuracy, clarity, and compliance
o Participate in team meetings, regulatory interactions, and strategy discussions
o Drive document production timelines according to established plans
o Plan and manage multiple simultaneous document development projects with shifting priorities
EDUCATION PREFERRED
Advanced degree (PhD, PharmD, MD, or MSc) in Life Sciences, Medicine, Pharmacy, or a related field
WORK EXPERIENCE
Minimum 3-5 years of medical writing experience in the pharmaceutical, biotech, or CRO industry
Strong background in writing regulatory documents for clinical trials and submissions
Epilepsy or Neurology experience is a plus
Experience with drug development across different phases (Phase I-IV) is a plus
Strong understanding of the drug development process, clinical research concepts, clinical study conduct, clinical study data collection, regulatory requirements, and biostatistical concepts
Familiarity with medical terminology and ability to interpret complex clinical data
Strong understanding of the concepts of coding dictionaries (MedDRA, WHODrug, etc.)
Excellent scientific writing, editing, and document structuring skills
Ability to simplify complex scientific concepts for diverse audiences
Proficiency in ICH guidelines, GCP, and regulatory submission requirements (FDA, EMA, etc.)
Strong attention to detail, ability to manage multiple projects, and meet deadlines
Ability to work independently and collaboratively in a fast-paced environment
High level of Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
Experience with document management systems and publishing tools (e.g., EndNote, Adobe Acrobat, regulatory submission platforms)
Veeva experience
Skills
Audit, Gcp, cro audit, tmf, edc
Top Skills Details
Audit,Gcp,cro audit,tmf,edc
Additional Skills & Qualifications
NEW UPDATED REQ INFO
SK Life Science is looking to fill one additional Medical Writer position. The job description has been reattached here for your references, as well. Please do not submit candidates into SWM VMS unless they meet all requirements below:
Advanced degree (PhD, PharmD, MD, or MSc) in Life Sciences, Medicine, Pharmacy, or a related field
Minimum 3-5 years of medical writing experience in the pharmaceutical, biotech, or CRO industry
Strong background in writing regulatory documents for clinical trials and submissions
Ability to simplify complex scientific concepts for diverse audiences
Proficiency in ICH guidelines, GCP, and regulatory submission requirements (FDA, EMA, etc.)
Strong attention to detail, ability to manage multiple projects, and meet deadlines
Ability to work independently and collaboratively in a fast-paced environment
High level of Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
Experience with document management systems and publishing tools (e.g., EndNote, Adobe Acrobat, regulatory submission platforms)
Veeva experience
Must Haves:
5 years of Medical writing experience
Most urgent need is supporting phase 3 study
CSPs, CSRs, IBs, ICFs, supporting regulatory documents
Should be able to be lead author independently (2-3 years experience authoring)
Global phase 3 studies, pivotal studies
Technology: Veeva RIM, Microsoft suite,
4 year degree
CNS experience
Like to Haves:
epilepsy experience highly preferred
Clear communication skills necessary
Someone that may be able to come into the office once a quarter would be ideal
EST working time zone required, living in EST preferred
Job Type & Location
This is a Contract position based out of Paramus, NJ.
Pay and Benefits
The pay range for this position is $70.00 - $80.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Apr 20, 2026.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.
