Senior Medical Writer - Safety Focus

Certara Philippines, Inc.; Philippines; Hybrid; PHP 1,000,000 - 2,000,000; Full time

Job summary

Veristat is seeking a Senior Medical Writer - Safety Focus to lead authoring of aggregate safety reports across DSURs, PSURs, PBRERs and related safety deliverables.

You will act as project lead on smaller engagements, interfacing directly with clients, and support larger programs as a member of a larger delivery team, ensuring timely, compliant, high-quality submissions.

Qualifications

• Bachelor’s degree or higher, in a scientific discipline strongly preferred.
• 5+ years of regulatory writing experience with aggregate safety report writing including: DSURs, PSURs, PBRERs, RMPs, PADERs, ACOs, safety topic reviews.
• Experience leading an internal project team and understanding regulatory authority guidelines and requirements.

Responsibilities

• Lead authoring of aggregate safety reports and interface directly with clients.
• Act as project lead on smaller engagements and support larger engagements as a delivery-team member.

Skills

Regulatory writing

Attention to detail

Client interfacing

Team collaboration

Data synthesis

Time management

Education

Bachelor's degree in a scientific discipline

Job description

Position specific overview

The Senior Medical Writer - Safety Focus is a major contributor to document authorship for a variety of aggregate safety reports within the safety service line. The Medical Writer - Safety Focus will be the project lead on smaller projects, interfacing directly with the client, but also support larger, more complex engagements as a member of a larger delivery team.

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!

Work Arrangement:

Veristat is on a hybrid setup that allows employees to work both in the office and at home.

Education, Experience, Training, and Knowledge

• Bachelor’s degree or higher, in a scientific discipline strongly preferred
• 5+ years of regulatory writing experience with aggregate safety report writing including: Development safety update reports (DSURs); Periodic safety update reports (PSURs); Periodic benefit-risk evaluations reports (PBRERs); Risk management plans (RMPs); Periodic adverse drug experience reports (PADERs); Addenda to clinical overviews (ACOs); Safety topic reviews
• Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptanceExperience in the development of aggregate safety reports

Skills & Abilities:

• Proficiency with Microsoft Word skills (editing tools, creating, and modifying tables, and inserting figures) and document management techniques
• Strong understanding of the document creation process and of the drug development lifecycle
• Ability to work in a collaborative environment, be tolerant of differences in culture and beliefs, easily build relationships with others, openly share information, and willingly contribute toward accomplishment of team goals
• Be action- and detail-oriented, always seeking new development opportunities to build knowledge and skills
• Show flexibility to meet project needs as required by deadlines and to meet corporate goals and objectives
• Remain knowledgeable of changes in the industry and adapt best practices
• Demonstrate solid time management and other organizational skills
• Ability to synthesize data across multiple data sources and documents to create summary reports
• Ability to use logical arguments to persuade others when presenting ideas and suggestions but also respond positively to opposing views voiced by others
• Develop professional relationships with clients to further the business relationship and maintain current industry knowledge
• Ability to identify and institutionalize work practices that are most effective to ensure consistency in performance

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.