Principal Medical Writer- MedPubs Focus

Job summary

The Principal Medical Writer plans and prepares regulatory documents and medical communications to support product development. They are responsible for analyzing and presenting scientific information in accordance with industry guidelines and company standards.

Job details

Job Description: Key Purpose: The Principal Medical Writer independently plans and prepares a range of regulatory documents and/or medical communications to support all phases of product development. The primary responsibilities of the position are organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with industry guidelines (International Council for Harmonisation (ICH) and other regulatory guidelines, or International Committee of Medical Journal Editors (ICMJE) and Good Publications Practice (GPP) guidelines, as appropriate) and individual company document standards. The Principal Medical Writer works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams as appropriate. Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. * 105+ approved therapies for marketing applications prepared by Veristat * 480+ oncology projects in the past 5 years * 350+ rare disease projects delivered in the past 5 years * Flexible, inclusive culture — 70% remote workforce, 66% women-led teams Learn more about our core values here [https://www.veristat.com/veristat-culture-our-core-values]! What we offer: * The estimated hiring range for this role is $ 132K-151K plus applicable bonus. This hiring range is specific to the US and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data. * Benefits vary by location and may include: * Remote working * Flexible time off * Paid holidays * Medical insurance * Tuition reimbursement * Retirement plans What we look for: * Bachelor’s degree required; PhD, MD or PharmD preferred; science-related field preferred. * Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting. * Experience as a lead writer on a minimum of 20 manuscripts, 20 abstracts, 20 posters or oral presentations across all phases of drug development and therapeutic areas. * Advanced knowledge of ICH and related regulatory guidelines and/or ICMJE and GPP guidelines; ISMPP CMPP certification preferred. Skills & Abilities: * Proficient in MS Office Suite (advanced MS Word, PowerPoint and Excel); Adobe Acrobat for developing and editing poster slides, pdf poster layouts and slide sets * Knowledge publication guidelines and industry standards, adherence to client publication policies and procedures, confidentiality, secure file transfer, copyright and privacy protection. * Excellent oral and written communication skills to work across an organization, facilitate discussions with clients and internal and external authors * Strong analytical skills to anticipate client needs within client engagements, identify where improvements can be made and offer suggestions for making work more efficient * Maintain industry knowledge, identify and adopt work practices that are the most effective to ensure consistency in performance for self and the team Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process. Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

What you’ll do

The Principal Medical Writer plans and prepares regulatory documents and medical communications to support product development. They are responsible for analyzing and presenting scientific information in accordance with industry guidelines and company standards.

Requirements

Requires a Bachelor's degree (PhD, MD, or PharmD preferred) and at least 7 years of medical writing experience in a CRO or pharma setting. Candidates must have a proven track record as a lead writer on at least 20 manuscripts, abstracts, or posters.

Benefits

• Remote Working
• Flexible Time Off
• Paid Holidays
• Medical Insurance
• Tuition Reimbursement
• Retirement Plans

Listed skills

• Client · Preferred
• Flexible · Preferred
• Decision Making · Preferred
• Organization · Preferred
• Teams · Preferred
• Time · Preferred
• Adobe · Preferred
• Analytical · Preferred
• Communication · Preferred
• Communication Skills · Preferred
• Development · Preferred
• management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Medical Writing
• Regulatory Writing
• Manuscript Preparation
• ICH Guidelines
• ICMJE Guidelines
• GPP Guidelines
• MS Office Suite
• Adobe Acrobat
• Analytical Skills
• Oral Communication
• Written Communication
• Publication Planning

Job areas

• Science & Research
• Healthcare
• Consulting

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