Medical Writing

2 weeks ago

Chennai Tamil Nadu, India Guires Solutions Pvt Ltd Full time

**Industry**

Pharmaceuticals, Cosmetics, Medical Devices, Food Supplement, Labeling and Scientific Communications

**Position**

Full Time, Permanent

**Division**

Pubrica Brand

**Reports to**:
Pubrica Business Head

**About Company**

Guires Group is a renowned global provider of services in advanced Contract Research, Data Science, Development, Pilot Manufacturing, Education, Consulting and outsourcing. Under our diverse brand portfolio, we are dedicated to facilitating the development of innovative products and solutions across diverse industries."

**Job Function**

**Work Schedule**:
Full Time, Monday to Saturday, 10:00a.m. to 7:00pm. Hours may vary on occasion, depending on workload. Second and Fourth Saturday Holiday.

**Work Location**

Chennai, Tamil Nadu.

**Req. Qualification**:

- Bachelor’s degree in Life Sciences
- PhD, PharmD, or other post-graduate degree.

**Req. Experience**:

- Extensive experience in global operations and delivery, particularly in Business Process Outsourcing (BPO).
- Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise).
- 1+ years’ experience leading medical writing projects.
- 1+ years’ experience leading activities or components of a project to meet business, publication and regulatory submission needs.
- 1+ years’ experience scientific or medical and regulatory writing, clinical trial documents/or publications experience specifically within the biotech and pharmaceutical industry
- Demonstrated project management and time management skills.
- Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates).

**Req. Knowledge and Skills**:

- Proven track record in Publication Management and Regulatory Affairs Program Management.
- Strong business development skills.
- Expertise in MIS reports & Analytics.
- Exceptional planning and leadership abilities.
- Demonstrated proficiency in transition management.
- Outstanding problem-solving and decision-making skills.
- Effective personnel management experience.
- Demonstrated success in customer relationship management.
- Ability to drive productivity and efficiency improvements.
- Experience in process creation and improvement.
- Exceptional communication skills, including the ability to present ideas and data clearly to senior-level stakeholders.
- Creative problem-solving skills with a record of impactful decision-making.
- Capability to lead and manage projects of increasing complexity.
- Familiarity with the role of other disciplines contributing to drug development programs.

Key Responsibilities
- Strategic Business Development: Develop and execute strategies to enhance our Regulatory Affairs business units, including Publication, Research & Development, focusing on niche solutions and thought leadership.
- Client Management: Act as the primary point of contact for multiple pharmaceutical and medical device clients, ensuring the successful delivery of scientific communication and Regulatory Affairs services.
- Sales and Solutioning: Lead RFP responses, prospecting efforts, and client presentations, offering expert consulting and sales pitches within the regulatory affairs domain.
- Functional Expertise: Provide expertise in Regulatory Affairs functions, including Regulatory Affairs Strategy CMC & Operations, Publishing & Submission, RIMS, Labeling & Artwork Management, Medical Writing, Scientific Communication, Publication, and Research & Development.
- Manage projects and stakeholders. Lead the writing process, use project management skills to finish regulatory documents on time, and create and communicate realistic timelines. Identify and address potential issues, collaborate with teams and stakeholders for document development, and keep everyone informed about project status.
- Content strategy and execution including document preparation development, and finalization/document management: Gather and analyze data from various sources to create a clear content strategy. Write, edit, and oversee regulatory documents for clinical development, ensuring accuracy. Lead authoring team meetings and coordinate reviews. Maintain consistency in data and negotiate timeline changes. Collaborate with experts and manage relationships with vendors when necessary.
- Knowledge skill and development: Continuously enhance your expertise in your assigned therapeutic area, including diseases and compounds. Be flexible to handle various document types, therapeutic areas, and compounds as project demands shift. Stay current with regulatory and publication guidelines. Develop a comprehensive understanding of your compound, therapeutic area, and the external landscape, including competitors, to effectively contribute to clinical planning, submission strategies, and regulatory responses, while also sta

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