• Job Details

  • Job Details
  • Job Title / Designation :

    Deputy General Manager - Medical Writing
  • Number of Vacancies :

  • Job Description :

    This role involves Leading and Managing delivery of project/s in terms of resourcing, quality, timeliness, efficiency and high technical standards for deliveries made by Medical Writing group including scientific documents and Clinical/Medical reports produced for assigned clinical studies. Also specialize in a specific TA/Portfolio/Segment and contribute to overall quality enhancement by ensuring high scientific standards for output produced by the medical writing group through expert review and feedback mechanism to delivery teams. Develop standards and work in cohesion with internal/client functional leads.

    Technical Responsibilities :
    Independently author high level Medical/Clinical & Scientific writing documents in accordance with the SLAs/ KPIs agreed upon with the clients with respect to timelines & quality
    Perform scientific review of medical writing documents produced by teams.
    Ensure adherence to Cognizant and Client SOPs (Standard Operating Procedures)
    Comply with project / trial standards and specifications following internal guidelines as well as the guidelines set by the various health/regulatory authorities.
    Perform quality control checks for all the generated reports/documents.
    Adherence to QMP Quality Management Process
    Participate in innovation and process improvement initiatives
    Provide inputs as necessary into planning, processes and key operational metrics viz. timelines, quality, efficiency
    Coordinate and communicate effectively with primary contacts at Client teams to ensure satisfactory progress of project work and timely resolution of issues
    Participate in client or regulatory audits.
    Cross functional teams Work with Biostatisticians, Statistical programmers & other functions in completion of reports.
    To assist management team in providing status and metrics on deliverables, resource utilization, productivity and quality of deliverable

    Operations/Project Management Responsibilities (as applicable):
    Plan and organize activities for successful delivery of the portfolio/project
    Responsible for planning, processes and key operational metrics viz. timelines, quality, efficiency
    To lead engagement level activities related to Operations, People and Client management. Prevent client escalations by timely mitigation measures for operational & people issues that may impact the targets & delivery
    Contribution to business development activities RFP, bid defense, Budgets, operations setup
    Manage project level budgets, P&L and invoiving.
    Review & approve project related expenses.
    Risk Management to maintain business continuity
    Ensure audit readiness
    Leading client or regulatory audits
    Optimal deployment & utilization of resources
    Risk Management to maintain business continuity
    Strategize and contribute towards process improvement initiatives.

    Team Management Responsibilities
    Plan and Manage timelines for assigned projects for self and team. Be responsible for day to day progress of work.
    Responsible for performance management of team through goal setting and periodic reviews.
    Identify development needs and ensure training fulfillment for the team Ensure completeness of individual training records/ log and update their training plan as per role requirement/s
    Mentor, Coach & act as SME for team members in resolving any technical and operational issues
    To train the team members in or Clients SOPs and Working Standards/ Instructions, Regulatory Guidelines.
    Ensure teams compliance to organizational policies and procedures
    Process Capture and analyze study team metrics
    Manage employee retention
    Contribute to Recruitment activities as required

  • Work Experience :

    Between 12 Years to 15 Years
  • Functional Area :

    Pharma / Biotech / Healthcare / Medical / R and D
  • Industry Type :

  • Keywords :

    Medical Writing
  • Job Location :

  • Desired Candidate Profile
  • Profile Description :

    Minimum Experience required: Relevant experience in medical writing/information domain with:
    10 years for Educational qualifcations 1 & 2.
    8 years for Educational qualifcations 3.
    Minimum 5 years in Managerial capacity for operations management role.

  • Basic/Graduation :

    Any graduate
  • Post Graduation :

  • Recruiter Contact Details
  • Contact Person :

    Ms.Supriya Ranaware
  • Address :

    308 - 309, Metro House, 7/B, Mangaldas Road, Opp. TMTC, Pune - 411 001.