Manager, Medical Writing (Medical Information)

Job Description

*Manager, Global Medical Information and Scientific Affairs responsible for ensuring timely delivery of clinical trial disclosure documents and medical information responses for Global OTC products. Responsible for the overall performance of the team including timely planning and proper execution of projects and deliverables. In addition, responsible for the performance and development of employees by setting the direction to the team, setting the strategies and ensuring high professional structure and standards within the team.These Responsibilities Include Some Of The FollowingManagement Responsibilities

1. 1. Medical Information and Clinical Trial Disclosure specific management responsibilities for team members.
   2. Make necessary recommendation to higher management on recruitment and budgeting
   3. Monitor teams performance on regular basis and suggest appropriate actions
   4. Supports the company s leadership team in the planning, development and implementation of document development strategies and development and presentation of quarterly business updates.
   5. Review client and departmental metrics by assisting in the tracking, maintaining and reviewing project related metrics as per the schedule
   6. Supports business development by assisting with proposal and costing development as well as bid defenses and customer meetings.
   7. Mentor the team for optimal and high quality delivery within assigned timelines and ensure development plan of team members is in place and followed
   8. Builds and maintain relationships with internal and external customers.
   9. Participates in the planning, writing, and review of deliverables, as needed.

Technical ResponsibilitiesClinical Trial Disclosure

• • Responsible for end to end delivery of disclosure documents in the area of regulated and policy driven clinical disclosures and data sharing. Deliver on complete, consistent and timely disclosure of documents in scope for public disclosure registries Clinicaltrials.gov, EU Clinical Trials Register, EU PAS register.
  • Coordinate/ Author disclosure documents (protocol summaries/ results summaries) and ensure review and approval of the same by the stakeholders according to defined SOPs and operational guides.
  • Ensure timely delivery of data disclosure artefacts (e.g. redacted full protocols, statistical analysis plans and clinical study reports), as required by applicable external regulations/ internal company policies.
  • Partners with clinical study team members to ensure disclosure requirements are addressed early during the process of protocol development. Reviews protocol/ concept protocol as appropriate, for compatibility with requirements of external registers.
  • Support consistent process for trial disclosure activities throughout the therapy area. Contribute to the development of procedural documentation including guidance documents and / or instructional documents. Support maintenance and improvement of processes for disclosure function according to evolving requirements.
  • Update Disclosure systems for disclosure activities planning, tracking and delivery. Ensures archival of final records in applicable systems for the posting of the documents on the required registries.
  • Support risk management framework implementation, including risk identification, assessment and prioritization and the definition of mitigation plans. Support risk mitigation for identified business transparency risks and manage the implications of these risks on disclosure documents.
  • Ensure compliance to organizational key performance indicators and monitor for continuous improvement in clinical data transparency and data sharing (e.g. Transparency Dashboard).
  • Contribute to the development of training material for the business, clinical support services and service provider(s).
  • Maintain awareness of changes in the disclosure, transparency and data sharing landscape, including new legal, regulatory requirements and industry trends and translate into GSK s Clinical Trial Disclosure and Transparency processes.

Medical Information

• • Conduct regular monitoring of enquiries in progress
  • Timely escalation of identified issues to client
  • Work on the mitigation plan with team members and ensure that appropriate action plan is in place and completed

, *We are looking for:

• • University Scientific Degree Master or equivalent professional experience
  • Broad scientific/ pharmaceutical industry background with at least 9 years of experience in scientific writing, regulatory writing, medical information or publications writing.
  • Awareness of ICH-GCP guidelines and regulations governing clinical trial disclosure (FDAAA 801 Final Rule, European Clinical Trial Directive, European Clinical Trial Regulation) and medical information
  • Experience with Clinical Trial Disclosure software solution(s).
  • Experience in Pharmaceutical company environment and specifically in matrix organization.
  • Operational knowledge and understanding of statistical concepts in clinical research.
  • Proven sense of urgency.
  • Excellent English language written and verbal communication skills in addition to proven negotiation skills.
  • Ability to resolve problems with use of knowledge, information and networks in a flexible way and to be successful in a matrix environment.
  • Self-motivated with the ability to work independently, to develop credibility with colleagues.
  • Comfortable to evolve in changing and challenging environment.

Keyskills :
end to end deliverydevelopment of employeesrisk management frameworkstatistical analysis planskey performance indicatorsenvironmental impact assessmentdata sharingclinical datastatements of work sow