Medical Affairs Project Specialist Lazio

Medical Affairs Project Specialist
Roma
Lazio, Lazio

Position Overview**: Basic Functions & Responsibility

The Medical Affairs Project Specialist is responsible for overseeing various activities (outlined below) of local Medical Affairs team and ensuring, for these activities, compliance to applicable our Research & Development Division"-GMSA policies and standard operating procedures (SOPs) as well as to the relevant local laws, regulations and local Industry Association Code of Practices.

**Primary Activities**:

Guide and drive the implementation of LDG and IIS our Research & Development Division"-GMSA policies, SOPs and guidelines at local level

Ensure that local implementation of LDG and IIS our Research & Development Division"-GMSA policies and SOPs is compliant with local laws, regulations and local Industry Association Code of Practices

Author local LDG and IIS SOPs, Execution Resource, work instructions, references and other governing documents when needed

Support Medical Operations Manager in the local implementation of the our Research & Development Division"-GMA LDG and IIS execution strategy in alignment with local Legal & Compliance Dept.

and HH Business Practices Manager

Identify and manage potential inconsistencies with LDG and IIS our Research & Development Division"-GMA policies and SOPs

develop and drive culture of compliance and integrity

Serve as local Point of Contact mostly for Local Data Generations and Investigator Initiated Study

Act as Country LDG point of contact of Medical Affairs for regional and global initiatives

Advise Medical Operations Manager and Therapeutic Area Leads on local quality and compliance issues

Coordinate therapeutic Area in updating Information &Technology system (eg: RevOps)

Collaborate with cross-functional teams to ensure readiness for LDG and IIS audits and inspections

Participate in LDG&IIS audits and inspection when required

Provide guidance to Medical Affairs on subsidiary LDG and IIS updates while gaining cross functional and cross-Country alignment

Monitor local LDG&IIS Medical Affairs processes in terms of actual practice and compliance to regulations.

Locally act as LDG&IIS compliance champion

**JOB REQUIREMENTS**:

**Education**:

University scientific Degree

**Master's scientific degree or an equivalent (eg**: clinical research, GCP, GPP, GXP);

**Skills**:

Strong analytical, organizational, and strategic thinking skills

Ability to work both independently and as part of a team to resolve complex matters

Communication skills (written/spoken)

Ability to work in a global environment

Ability to author and review SOPs

Ability support audits and inspections

Strong analytical, organizational, and strategic thinking skills

Ability to work both independently and as part of a team to resolve complex matters

Communication skills (written/spoken)

Ability to work in a global environment

Ability to author and review SOPs

Ability support audits and inspections

understand and intelligently applies data to make decisions that drive value for Medical Affairs and our customers.

think and acts beyond one's silo - bridges boundaries across teams, functions, divisions, geographies, external stakeholders and customers.

visualize the way forward, identifying opportunities that add value to the work, and to our internal customers.

organizes work efforts by prioritizing tasks, using resources optimally, establishing appropriate deadlines and ensuring on-time delivery.

plans and delivers ideas and information to others in a clear and impactful manner.

ability to consolidate and understand data, plan and/ or execute data analyses, summarize and synthesize data and objectively interpret results.

ability to objectively communicate analysis and results in verbal and written terms that can be understood by a variety of stakeholders.

**Experience**:

5 years of experience in the Pharmaceutical industry

hold observational studies and independent research project roles in medical affairs for at least 5 years gaining experience with respect to the local regulatory environment, relevant international and local codes of practice, guidelines and regulations

Previous US FCPA management activities is strongly recommended

policies, SOPs understanding and management are strongly required

understanding and use of processes and systems is in asset

Comprehensive understanding of Ex-US Standards is required.

Who we are

We are known as Merck & Co. , Inc. , Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else.

For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.

Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve live