Scientific Writing_Lead
Indegene · Bengaluru, Karnataka, India
About the Job
We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com.
What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it? We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers. We are a rapidly growing global organization and are
scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you. If this excites you, then apply below.Scientific Writing Lead
You will be responsible for:
- Responsible for authoring Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), Post-Market Surveillance Reports (PMSR), Periodic Safety Update Reports (PSUR), Annual Summary Reports (ASR), Post-Market Clinical Follow-up Plans and Evaluation Reports (PMCFP/PMCFER)
- Acquire knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature
- Develop literature search and data extraction strategy for search, screening, and summarization of articles, and develop in-depth knowledge and understanding of current scientific literature
- Participate in and/or perform comprehensive literature searches to support identified product lines and related clinical studies
- Stay informed about applicable clinical landscapes and trends
- Review literature search results and interpret and summarize risks, alternate therapies and device specific benefits; collect and summarize primary data to support risk assessment
- Critically appraise scientific literature and write clinical summaries for products literature to elucidate the clinical problem and current treatment techniques
- Evaluate data for similar competitor devices
- Perform data fact check of the documents authored
- Collaborate with the project/program stakeholders for product information to develop quality content for CERs, within the required timelines
- Manage assigned client account and ensure successful on time delivery of all deliverables as listed in the SoW
- Responsible for end-to-end technical execution of the project
- Work with PMO to ensure resources with the right skill set are assigned to the project
- Work with PMO for resource allocation and end-to-end project plan
- Act as client point of contact for day-to-day communication and project execution
- Guiding writers on end-to-end execution of the assigned deliverable
- Day-to-day communication with primary and supporting writer for project execution
- Review queries for project Kick-off meetings and status update calls
- Review assets tracker
- Guiding team members in product understanding, gathering inputs, literature search strategy and systematic literature review, literature screening and data extraction
- Working as subject matter expert for reviewing, revising and improving the quality of scientific content and content created by primary writers
Your Impact
About You:
- Experience in leading a team
- Experience in creating process flows, SOPs, Templates
- Good understanding of medical devices and an overall understanding of the medical field
- In-depth knowledge of EU MDR, MEDDEV 2.7.1 Rev 4, IMDRF and MDCG; translate the client requirements and apply in drafting of CE documents
- Good knowledge on EU MDR specifics related to Clinical Evaluation, Clinical risks and Benefits, Safety and Performance etc
- Strong flair and passion for technical writing
- Strong written and verbal communication/presentation skills
- Being up-to-date with the latest technical/scientific developments and relating them to various projects
- Ability to understand client requirements and KPIs
Must Have:
- Graduate or Post Graduate in Life Sciences (Pharm.D/M.Pharm/BDS/MBBS) or Bio Medical Engineering with 5 to 7 years experience
- 4+ experience in med device clinical affairs domain
- Sound experience in the application of therapeutic and device knowledge for development of clinical evaluation documents
- Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical evaluation assessment and report development
- Strong experience in conducting literature searches, reviews and appraisal of the scientific data
- Clear and effective communication, both verbal and written
- Excellent critical and analytical thinking skills
- Review experience in clinical evaluation (CEP/CER/SSCP) and post-market deliverables (PMSR/PSUR/PMCFP/PMCFER), IVDRs (PEP/PER)
- High level of attention to detail and accuracy
- Able to work effectively with cross-functional teams
- Able to manage multiple projects across numerous disciplines
- Strong communication, presentation, and interpersonal skills with high attention to detail and organization
- Consistent dedication and strong work-ethic to help meet aggressive timelines or multiple projects when necessary
- People management, with the ability to manage a team of 3-5 writers
APPLY VIA YOUR LINKEDIN ACCOUNT
Keywords: Scientific Writing Lead, med device clinical affairs domain, clinical evaluation, medical devices, technical writing, life sciences, EU MDR
