Group Lead - Medical Information

Job description

Job title: Group Lead – Medical Information Hiring Manager: Head – Scientific Communications, Medical Information & Graphics Location: Hyderabad % of travel expected: As per business need Job type: Permanent and Full time About the job Our Team: Sanofi Business Operations (BO) is an internal Sanofi resource organization setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CMO, and R&D, Data & Digital functions. BO strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? Main responsibilities: The overall purpose and main responsibilities are listed below: Provides functional and operational leadership to the Medical Information Writing Team, acting as the domain expert for the relevant activities within the Medical Information team, engaging stakeholders, developing the team members, and acting as a strategic thought partner aligned with the vision of the Medical Writing team. Independently research and authors response documents, reviews compendia, and prepares US FDA Annual reports with minimal guidance or supervision by the global and local Medical Information team. Proficient understanding of Medical Information achieved through a combination of product knowledge, along with editing, writing, and document management. Essential job duties and responsibilities: 1) Acts as a strategic thought partner to the Global Medical Information function aligned with the vision of Medical Writing. 2) Proficient in Conducting literature searches and reviews; and extracting/ summarizing complex data from the scientific literature. 3) Independently works to generate evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific response documents for products in multiple therapeutic areas, develops US FDA Annual Reports, and reviews compendia 4) Ability to produce medical documents according to all Sanofi relevant global guidelines, country guidelines and policies. 5) Acts as a Subject Matter Expert maintaining expertise in the processes, templates, and guidelines, and key deliverables aligned with the key trends and developments in the industry. 6) Provides operational and functional leadership in producing high-quality deliverables from the medical writing team. 7) Peer reviews, coaches, mentors, and develops expertise within the team motivating people to excellence (on key deliverables, processes, templates, and guidelines). 8) Guides and have oversight of the end-to-end process as captured in the activity catalogue. 8) Works in alignment with line function visions, demonstrating great collaboration with the team. 9) Agile and knowledgeable to be able to work across different therapeutic areas and new deliverable types, willing to stretch and be the front-runner. 10) Demonstrates resolve and urgency to accomplish tasks without direct authority or control. Participate in cross-functional project teams as needed. Ensure that assigned projects are completed on schedule. 11) Collaborates effectively with Global Medical Information teams to execute content plans 12) Demonstrates a deep understanding and/or experience of working in a regulated GXP environment To create synergies and provide functional and operational direction across global business units, segments and key markets operations across various therapeutic areas and processes so that cost savings up to 10 mil euros are achieved with deliveries optimized through multi-layered teams People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) across multiple Global business units and products – with an end objective to develop medical information content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical information writers in developing knowledge and sharing expertise. Performance: 1) Act as a strategic thought partner, operational and functional leader, providing coaching, mentoring, and expertise support. 2) Provide functional expert support and oversight of deliverables (local and custom scientific response documents, US FDA Annual Reports, and Compendia Reviews) as per agreed timelines and quality. 3) Supports delivery of projects in terms of resourcing, quality, timeliness, efficiency, and high technical standards. 4) Implement relevant elements of the medical information writing plan and associated activities for the year identified for the countries and regions. Process: (1) Support delivery of projects in terms of resourcing, quality, timeliness, efficiency, and high technical standards for deliveries made by the group, including scientific documents and clinical/medical reports; (2) Contribute to overall quality enhancement by ensuring high scientific standards for the output produced by the group; (3) Secure adherence to compliance procedures and internal/operational risk controls in accordance with any and all applicable regulatory standards; (4) Implement relevant elements of content plans and associated activities for the year identified for the assigned countries. 5) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 6) Design an overall plan of action basis end-customers feedback & improve course content and delivery, continuous improvement and efficiency. Stakeholder: Work closely with medical teams globally across GBUs as well as in countries/regions/areas to identify medical information needs and assist in developing assigned deliverables. 2) Liaise with the Medical department to prepare relevant & customized deliverables. 3) Collaborate with the Global Medical Information team and country medical information teams as relevant. 4) Support regulatory interactions with various health authorities for inspections. About you Experience: ≥10 years of experience in content creation in medical information or scientific writing for the pharmaceuticals/healthcare industry, or equivalent experience in the clinical setting, pharmacovigilance; At least 10 years of direct medical information writing experience in the pharmaceutical company; Minimum 3 years of experience in managing global, cross-functional teams and working in, a Matrix environment; strong ability in managing a multi-layered team of ≥10 members; and ability to influence and negotiate difficult situations. Soft skills: Excellent communication skills (written, verbal, and presentation), Team management, and Stakeholder management; communication skills; and ability to work independently and within a team environment, demonstrated ability to motivate, coach, or mentor people, work as an SME, develop and manage high performing teams Technical skills: As applicable (Including but not limited to Expert knowledge of medical information documents including Response documents, Compendia review and FDA Annual Reports, Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills, Knowledge about literature evaluation and multilevel response development). Understanding of the local country legal requirements with regards to Medical Information document provision for customers including health care professionals, patients, carers and other relevant decision makers (such as ABPI Code of Practice for UK) is desirable. Education: Advanced degree in life sciences/pharmacy/similar discipline (Ph.D., Master, or bachelor’s in science, D Pharms) or medical degree (MBBS, BDS, BAMS, BHMS, MD) Languages: Excellent knowledge