Senior Associate, Medical Writing (MD)

ClinChoice

Pasig City, Philippines

Who this role is best for

Strong fit for medical writing professionals who perform systematic literature reviews and ensure compliance with data protection standards.

Best fit for

Candidates who can work in a diverse team and demonstrate strong time management skills
— “Can work in a diverse team environment”
Proficient in English and Microsoft Office, with a focus on regulatory compliance
— “Proficiency in oral and written English language”

Things to consider

Confidentiality and data protection compliance are non-negotiable requirements
— “Responsible for confidentiality, integrity, availability, and safeguarding of data”
Regulatory compliance with QMS, ISMS, and PIMS is a mandatory commitment
— “Complies with company QMS, ISMS, and PIMS requirements and applicable regulatory requirements”

How to stand out

Highlight experience with FDA-related reports and systematic literature reviews
— “Performs tasks according to the assigned medical writing activities including systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER)”
Emphasize ability to ensure quality and meet performance standards independently
— “Ensures error-free and acceptable quality of assigned deliverables”
Demonstrate familiarity with HEMA research and PMS/PSUR report writing
— “Performs tasks according to the assigned medical writing activities including ... Post-Market Surveillance (PMS) including Periodic Safety Update Reports (PSUR)”

Pace · SteadyCollaboration · MediumAutonomy · MediumDecision Impact · Team

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

generation of Clinical Evaluation Reports (CER)
Summary of Safety and Clinical Performance (SSCP)
State of the Art (SOA)
Post-Market Surveillance (PMS)

Typical background

1-3 years of experience in medical writing or related fieldBachelor’s degree in life sciences

Skills & requirements

Required

Medical WritingAnalytical SkillsTime ManagementMicrosoft Office

Preferred

Project ManagementTeam Collaboration

Stack & domain

Medical WritingSystematic Literature ReviewsClinical Evaluation Reports (cer)Summary Of Safety And Clinical Performance (sscp)State Of The Art (soa)Post-market Surveillance (pms)Periodic Safety Update Reports (psur)Premarket Approval (pma) Food And Drug Administration (fda) ReportsHumanitarian Device Exemption (hde)Investigative Device Exemption (ide) ReportsHealth Economics And Market Access (hema) ResearchTime ManagementMicrosoft Office Suites (word, Excel, PPT, Sharepoint)Analytical SkillsComprehension SkillsCommunication SkillsTeamworkProblem-solvingAttention To DetailHealthcare

About the role

Original posting from ClinChoice via Greenhouse

DUTIES & RESPONSIBILITIES:
Performs tasks according to the assigned medical writing activities including systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), State of the Art (SOA), Post-Market Surveillance (PMS) including Periodic Safety Update Reports (PSUR), and Premarket Approval (PMA) Food and Drug Administration (FDA) Reports, including Humanitarian Device Exemption (HDE), Investigative Device Exemption (IDE) Reports, and Health Economics and Market Access (HEMA) research. The specific tasks are to be determined based on the assigned role in the project.
Supports review of work done by peer teammates, on need basis
Alerts and escalates to senior members as required, whenever project deliverable risks are visualized, OR issues are encountered impacting the delivery schedule
Ensures error-free and acceptable quality of assigned deliverables
Responsible for ensuring training compliance and timesheet compliance
Ensures that all assigned goals (e.g., utilization and efficiency) are met as per set standards for the performance year
Follows and complies with the Company’s Code of Conduct, Policies, and Procedures
Responsible for confidentiality, integrity, availability, and safeguarding of data
Responsible for reporting of security incidents and PIMS breaches as applicable
Complies with company QMS, ISMS, and PIMS requirements and applicable regulatory requirements
Demonstrates adherence and compliance to PIMS/GDPR requirements as follows: data processed fairly, transparently, and lawfully; collected for specified and legitimate purposes; adequate, relevant, and limited to the specified purposes; processed in a secure manner
ROLE REQUIREMENTS:
At least 1-3 years of experience in medical writing, or any related field as applicable
Can work in a diverse team environment
Good analytical and comprehension skills
Proficient in time management and can work with minimal supervision,
Proficiency in oral and written English language
Proficiency in Microsoft Office Suites (e.g. Word, Excel, PPT, SharePoint).
EDUCATIONAL QUALIFICATIONS:
Minimum bachelor’s degree in any life sciences field

Source: ClinChoice careers (Greenhouse)