Pharmacovigilance Medical Writing Manager

Pharmacovigilance Medical Writing Manager

Position Summary

The Pharmacovigilance Medical Writing Manager is responsible for writing and editing a variety of scientific and medicalcontent including but not limited to the following: Aggregate Reports Risk Management Plan(RMP) Risk Evaluation andMitigation Strategies (REMS) protocols investigator brochures clinical study reports responses to regulatory questionsand other clinical and regulatory documents in accordance with applicable Good Clinical Practice requirements andlegislation. The medical writer will work independently to review Client documents and author the reports. The medicalwriter will collaborate with the PV Project Leads and other relevant functions to ensure accuracy and clarity of allrelevant content.

Essential

To accomplish this job successfully an individual must be able to perform with or without reasonable accommodationeach essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individualswith disabilities to perform the essential functions.

Essential Functions Statement(s)

• Proactively contribute to development and implementation of Medical Writing best practices policies SOPs andprocess improvement initiatives leading to efficient and improved standards and systems for authoring reviewediting and finalization of documents in compliance with applicable company SOPs and regulations;
• Develop and refine templates to improve inter-department/program alignment and efficiency in accordance withstandards and regulatory guidelines and requirements;
  
• Define document development strategy and resource needs for programs including medical writing vendorengagement and oversight;
• Drive document execution tactics such as: define document development implement review and revisionprocesses develop timelines including timelines related to document birth dates assign resources facilitatedocument-related meetings provide cross-functional updates and define data needs etc. to ensure timelycompletion of key documents for complex global programs;
  
• Author edit and quality review a variety of scientific and medical documents including but not limited to thefollowing: Aggregate Reports Risk Management Plan(RMP) Risk Evaluation and Mitigation Strategies (REMS)protocols investigator brochures clinical study reports responses to regulatory questions and other clinical andregulatory documents in accordance with applicable SOPs Good Clinical Practice requirements and legislation.
• Collaborate with clients and the PV staff to ensure that all documents meet the required standards for contentformat and style;
• Maintain up-to-date knowledge of relevant therapeutic areas and scientific developments;
• Develop and practice ongoing scientific expertise relevant to therapeutic areas product labelling pivotal studies anddisease state management;
• Integrate scientific expertise with regulatory and compliance guidelines to ensure comprehensive review andcreation of materials submitted into approval process;
• Use appropriate software/platforms/available tools to organize and maintain references for documents;
• Attend and participate in all appropriate client and internal meetings
• Support the continuous development of the Medical Writing capabilities; provide ongoing training/mentoring to thePV team members as needed;
• Inform the Global Head of PV and DS when required of the status of projects and in particular any issues thataffect document quality and project budget;
• Provide new business cost estimates when required and support the GHPD and Business Development team in newbusiness acquisitions for PV projects including medical writing services.

Position Qualifications

Competency Statements

• Excellent working knowledge of relevant terminology International Conference on Harmonization (ICH) GoodClinical Practice (GCP) Standard Operating Procedures (SOPs) applicable regulatory requirements qualitymanagement processes.
  
• Superior writing and editorial skills strong data analysis skills ability to interpret clinical data and understandcomplex scientific and clinical information and create consistent strategic messaging for diverse audiences.
• Ability to contribute to oversee and coordinate work of multiple PV staff members and vendor resources acrossmultidisciplinary teams
• Teamwork communication collaboration and alignment across a matrix organization are essential
• Commitment to delivering high-quality timely results leading by example demonstrating agility and navigatingambiguity are critical to success
• Demonstrates innovative capacity and ability to implement change

Ethical - Ability to conform to a set of values and accepted standards.
Accountability - Ability to accept responsibility and account for his/her actions.
Accuracy - Ability to perform work accurately and thoroughly.
Analytical Skills - Ability to use thinking and reasoning to solve a problem.
Detail Oriented - Ability to pay attention to the minute details of a project or task.
Self Motivated - Ability to be internally inspired to perform a task to the best of ones ability using his or her owndrive or initiative.
Organized - Possesses the trait of being well organized or following a systematic method of performing a task.
Technical Aptitude - Ability to comprehend complex technical topics and specialized information.
Financial Aptitude - Ability to understand and explain economic and accounting information prepare and managebudgets and make sound long-term investment decisions.
Tactful - Ability to show consideration for and maintain good relations with others.
Problem Solving - Ability to find a solution for or to deal proactively with work-related problems.
Active Listening - Ability to actively attend to convey and understand the comments and questions of others.
Customer Oriented - Ability to take care of the client needs while following company procedures.
Communication Written - Ability to communicate in writing clearly and concisely.
Communication Oral - Ability to communicate effectively with others using the spoken word.
Applied Learning - Ability to participate in needed learning activities in a way that makes the most of the learningexperience.
Demonstrated leadership skills.
Excellent influencing and negotiation skills.
Demonstrated ability to work in a matrix environment.
Ability to establish and maintain effective working relationships with co-workers managers and clients.

Fluent in English.

Experience

8-10 years of relevant experience including education and/or medical writing experience withinpharmaceutical/biotech industry.

Direct experience in the pharmaceutical/biotech industry with understanding of requirements for clinical trials anddrug development regulatory submissions pharmacovigilance reporting and medical communications

Other Requirements: pharmaceutical industry experience including an understanding and working knowledge ofglobal legal regulatory and compliance requirements with regards to pharmacovigilance.

Computer Skills

Proficiency with Embase OvidPV PubMed Microsoft Office Suite (Outlook Word Excel) safety databases such asOracle Argus Safety ArisG LifeSphere Veeva Safety AB Cube SafetyEasy etc.

WORK ENVIRONMENT

Remote

The company has reviewed this job description to ensure that essential functions and basic duties have been is intended to provide guidelines for job expectations and the employees ability to perform the position described.

It is not intended to be construed as an exhaustive list of all functions responsibilities skills and abilities. Additionalfunctions and requirements may be assigned by supervisors as deemed appropriate. This document does not representa contract of employment and the company reserves the right to change this job description and/or assign tasks for theemployee to perform as the company may deem appropriate.

Disclaimer

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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex national origin age disability genetic information or veteran status.

Recruitment Agency Notice:

Thank you for your interest in working with Med Communications. We kindly ask that recruitment agencies avoid sending unsolicited CVs as our in-house team manages all hiring processes.

Please be aware that any unsolicited CVs or candidate profiles received without prior engagement or agreement with our recruitment team will be considered free and carry no obligation on the part of Med Communications. We thank you for your compliance with our policy.

Should collaboration opportunities arise we will reach out to preferred partners proactively. Your understanding and cooperation are appreciated.